Trial Outcomes & Findings for Study of VIP152, Venetoclax, and Prednisone (VVIP) in Relapsed/Refractory Lymphoid Malignancies (NCT NCT05371054)
NCT ID: NCT05371054
Last Updated: 2025-11-25
Results Overview
CR rate is defined as the percentage of participants who meet criteria for complete response (CR) as measured by the Lugano Classification Response Criteria for Non-Hodgkin lymphoma (NHL). Complete response is defined as target nodes/nodal masses that regress to \<1.5 cm in longest transverse diameter of a lesion (LDi).
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE1/PHASE2
Target enrollment
8 participants
Primary outcome timeframe
24 cycles (i.e., 72 weeks)
Results posted on
2025-11-25
Participant Flow
Participant milestones
| Measure |
Cohort 1/Phase 1: Arm 1 Dose Escalation Dose Level 1 Enitociclib (VIP152) 15 mg & Venetoclax 600 mg
Enitociclib (VIP152), Venetoclax and prednisone (VVIP)-VIP152 and venetoclax at escalating doses with prednisone at fixed doses to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of VIP152 and venetoclax.
Vysis LSI MYC Break Apart Rearrangement Probe Kit: MYC rearrangement fluorescence in situ hybridization (FISH) testing is performed using the Vysis LSI MYC Break Apart Rearrangement Probe (Abbott Molecular, Inc.) in the Chromosome Pathology Section, Laboratory of Pathology, Center for Cancer Research (CCR), National Cancer Institute (NCI). This kit is not Food and Drug Administration (FDA) approved. It is being used as a treatment determining in-vitro diagnostic device in this study.
Venetoclax: Administered orally, days 1-10, per specified dose level; every 21 days for up to 24 cycles, or until disease progression or unacceptable toxicity VIP152: Administered intravenously, days 2 and 9, per specified dose level; every 21 days for up to 24 cycles, or until disease progression or unacceptable toxicity Prednisone: Administered orally, days 1-10, at a dose of 100 mg; every 21 days for up to 24 cycles, or until disease progression or unacceptable toxicity Cohort 1 Dose Escalation: participants with either refractory/relapsed (R/R) MYC-rearranged diffuse large B-cell lymphoma (DLBCL)/high-grade B-cell lymphoma (HGBCL), R/R non-germinal center B-Cell (GCB) DLBCL (no MYC rearrangement) and/or R/R peripheral T-cell lymphoma (PTCL)
|
Cohort 1/Phase 1: Arm 1 Dose Escalation Dose Level 2 Enitociclib(VIP152) 22.5 mg & Venetoclax 600 mg
Enitociclib (VIP152), Venetoclax and prednisone (VVIP) - VIP152 and venetoclax at escalating doses with prednisone at fixed doses to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of VIP152 and venetoclax.
Vysis LSI MYC Break Apart Rearrangement Probe Kit: MYC rearrangement fluorescence in situ hybridization (FISH) testing is performed using the Vysis LSI MYC Break Apart Rearrangement Probe (Abbott Molecular, Inc.) in the Chromosome Pathology Section, Laboratory of Pathology, Center for Cancer Research (CCR), National Cancer Institute (NCI). This kit is not Food and Drug Administration (FDA) approved. It is being used as a treatment determining in-vitro diagnostic device in this study.
Venetoclax: Administered orally, days 1-10, per specified dose level; every 21 days for up to 24 cycles, or until disease progression or unacceptable toxicity
VIP152: Administered intravenously, days 2 and 9, per specified dose level; every 21 days for up to 24 cycles, or until disease progression or unacceptable toxicity
Prednisone: Administered orally, days 1-10, at a dose of 100 mg; every 21 days for up to 24 cycles, or until disease progression or unacceptable toxicity
Cohort 1 Dose Escalation: participants with either refractory/relapsed (R/R) MYC-rearranged diffuse large B-cell lymphoma (DLBCL)/high-grade B-cell lymphoma (HGBCL, R/R non-germinal center B-Cell (GCB) DLBCL (no MYC rearrangement) and/or R/R peripheral T-cell lymphoma (PTCL)
|
Cohort 1/Phase 1: Arm 1 Dose Escalation Dose Level 3 Enitociclib (VIP152) 30 mg & Venetoclax 600 mg
Enitociclib (VIP152), Venetoclax and prednisone (VVIP) - VIP152 and venetoclax at escalating doses with prednisone at fixed doses to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of VIP152 and venetoclax.
Vysis LSI MYC Break Apart Rearrangement Probe Kit: MYC rearrangement fluorescence in situ hybridization (FISH) testing is performed using the Vysis LSI MYC Break Apart Rearrangement Probe (Abbott Molecular, Inc.) in the Chromosome Pathology Section, Laboratory of Pathology, Center for Cancer Research (CCR), National Cancer Institute (NCI). This kit is not Food and Drug Administration (FDA) approved. It is being used as a treatment determining in-vitro diagnostic device in this study.
Venetoclax: Administered orally, days 1-10, per specified dose level; every 21 days for up to 24 cycles, or until disease progression or unacceptable toxicity
VIP152: Administered intravenously, days 2 and 9, per specified dose level; every 21 days for up to 24 cycles, or until disease progression or unacceptable toxicity
Prednisone: Administered orally, days 1-10, at a dose of 100 mg; every 21 days for up to 24 cycles, or until disease progression or unacceptable toxicity
Cohort 1 Dose Escalation: participants with either refractory/relapsed (R/R) MYC-rearranged diffuse large B-cell lymphoma (DLBCL)/high-grade B-cell lymphoma (HGBCL, R/R non-germinal center B-Cell (GCB) DLBCL (no MYC rearrangement) and/or R/R peripheral T-cell lymphoma (PTCL)
|
Cohort 1/Phase 1: Arm 1 Dose Escalation Dose Level 4 Enitociclib (VIP152) 30mg & Venetoclax 800mg
No participants were enrolled in cohort 1/phase 1:Arm 1 dose escalation dose level 4. VIP152, Venetoclax, \& prednisone-Enitociclib(VIP152) \& venetoclax at escalating doses with prednisone at fixed doses to determine the maximum tolerated dose \& recommended phase II dose of VIP152 \& venetoclax. Vysis LSI MYC Break Apart Rearrangement Probe Kit:MYC rearrangement fluorescence in situ hybridization testing is performed using the Vysis LSI MYC Break Apart Rearrangement Probe (Abbott Molecular, Inc.) in the Chromosome Pathology Section, Laboratory of Pathology, Center for Cancer Research, National Cancer Institute. This kit is not Food and Drug Administration approved. It is being used as a treatment determining in-vitro diagnostic device in this study. Venetoclax:Administered orally, days 1-10, per specified dose level;every 21 days for up to 24 cycles, or until disease progression or unacceptable toxicity. VIP152:Administered intravenously, days 2 and 9, per specified dose level; every 21 days for up to 24 cycles, or until disease progression or unacceptable toxicity. Prednisone:Administered orally, days 1-10, at a dose of 100mg;every 21 days for up to 24 cycles, or until disease progression or unacceptable toxicity. Cohort 1 Dose Escalation:participants with either refractory/relapsed (R/R)MYC-rearranged diffuse large B-cell lymphoma/high-grade B-cell lymphoma, R/R non-germinal center B-Cell diffuse large B-cell lymphoma(no MYC rearrangement) \&/or R/R peripheral T-cell lymphoma.
|
Cohort 2/Phase 2: Arm 2 Dose Expansion with Enitociclib (VIP152) & Venetoclax
No participants were enrolled in cohort 2/phase 2: Arm 2 dose expansion.
Enitociclib (VIP152), Venetoclax and prednisone (VVIP) - VIP152 and venetoclax at the recommended phase II dose (RP2D) with prednisone at fixed doses.
Vysis LSI MYC Break Apart Rearrangement Probe Kit: MYC rearrangement fluorescence in situ hybridization (FISH) testing is performed using the Vysis LSI MYC Break Apart Rearrangement Probe (Abbott Molecular, Inc.) in the Chromosome Pathology Section, Laboratory of Pathology, Center for Cancer Research (CCR), National Cancer Institute (NCI). This kit is not Food and Drug Administration (FDA) approved. It is being used as a treatment determining in-vitro diagnostic device in this study.
Venetoclax: Administered orally, days 1-10, at the recommended phase 2 dose (RP2D); every 21 days for up to 24 cycles, or until disease progression or unacceptable toxicity
VIP152: Administered intravenously, days 2 and 9, at the recommended phase 2 dose (RP2D); every 21 days for up to 24 cycles, or until disease progression or unacceptable toxicity
Prednisone: Administered orally, days 1-10, at a dose of 100 mg; every 21 days for up to 24 cycles, or until disease progression or unacceptable toxicity
Participants with refractory/relapsed (R/R) MYC-rearranged diffuse large B-cell lymphoma (DLBCL)/high-grade B-cell lymphoma (HGBCL) for Phase 2 dose expansion.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
2
|
0
|
0
|
|
Overall Study
COMPLETED
|
3
|
3
|
2
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of VIP152, Venetoclax, and Prednisone (VVIP) in Relapsed/Refractory Lymphoid Malignancies
Baseline characteristics by cohort
| Measure |
Cohort 1/Phase 1: Arm 1 Dose Escalation Dose Level 1 Enitociclib (VIP152) 15 mg & Venetoclax 600 mg
n=3 Participants
Enitociclib (VIP152), Venetoclax and prednisone (VVIP) - VIP152 and venetoclax at escalating doses with prednisone at fixed doses to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of VIP152 and venetoclax.
Vysis LSI MYC Break Apart Rearrangement Probe Kit: MYC rearrangement fluorescence in situ hybridization (FISH) testing is performed using the Vysis LSI MYC Break Apart Rearrangement Probe (Abbott Molecular, Inc.) in the Chromosome Pathology Section, Laboratory of Pathology, Center for Cancer Research (CCR), National Cancer Institute (NCI). This kit is not Food and Drug Administration (FDA) approved. It is being used as a treatment determining in-vitro diagnostic device in this study.
Venetoclax: Administered orally, days 1-10, per specified dose level; every 21 days for up to 24 cycles, or until disease progression or unacceptable toxicity
VIP152: Administered intravenously, days 2 and 9, per specified dose level; every 21 days for up to 24 cycles, or until disease progression or unacceptable toxicity
Prednisone: Administered orally, days 1-10, at a dose of 100 mg; every 21 days for up to 24 cycles, or until disease progression or unacceptable toxicity
Cohort 1 Dose Escalation: participants with either refractory/relapsed (R/R) MYC-rearranged diffuse large B-cell lymphoma (DLBCL)/high-grade B-cell lymphoma (HGBCL), R/R non-germinal center B-Cell (GCB) DLBCL (no MYC rearrangement) and/or R/R peripheral T-cell lymphoma (PTCL)
|
Cohort 1/Phase 1: Arm 1 Dose Escalation Dose Level 2 Enitociclib(VIP152) 22.5 mg & Venetoclax 600 mg
n=3 Participants
Enitociclib (VIP152), Venetoclax and prednisone (VVIP) - VIP152 and venetoclax at escalating doses with prednisone at fixed doses to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of VIP152 and venetoclax.
Vysis LSI MYC Break Apart Rearrangement Probe Kit: MYC rearrangement fluorescence in situ hybridization (FISH) testing is performed using the Vysis LSI MYC Break Apart Rearrangement Probe (Abbott Molecular, Inc.) in the Chromosome Pathology Section, Laboratory of Pathology, Center for Cancer Research (CCR), National Cancer Institute (NCI). This kit is not Food and Drug Administration (FDA) approved. It is being used as a treatment determining in-vitro diagnostic device in this study.
Venetoclax: Administered orally, days 1-10, per specified dose level; every 21 days for up to 24 cycles, or until disease progression or unacceptable toxicity
VIP152: Administered intravenously, days 2 and 9, per specified dose level; every 21 days for up to 24 cycles, or until disease progression or unacceptable toxicity
Prednisone: Administered orally, days 1-10, at a dose of 100 mg; every 21 days for up to 24 cycles, or until disease progression or unacceptable toxicity
Cohort 1 Dose Escalation: participants with either refractory/relapsed (R/R) MYC-rearranged diffuse large B-cell lymphoma (DLBCL)/high-grade B-cell lymphoma (HGBCL, R/R non-germinal center B-Cell (GCB) DLBCL (no MYC rearrangement) and/or R/R peripheral T-cell lymphoma (PTCL)
|
Cohort 1/Phase 1: Arm 1 Dose Escalation Dose Level 3 Enitociclib (VIP152) 30 mg & Venetoclax 600 mg
n=2 Participants
Enitociclib (VIP152), Venetoclax and prednisone (VVIP) - VIP152 and venetoclax at escalating doses with prednisone at fixed doses to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of VIP152 and venetoclax.
Vysis LSI MYC Break Apart Rearrangement Probe Kit: MYC rearrangement fluorescence in situ hybridization (FISH) testing is performed using the Vysis LSI MYC Break Apart Rearrangement Probe (Abbott Molecular, Inc.) in the Chromosome Pathology Section, Laboratory of Pathology, Center for Cancer Research (CCR), National Cancer Institute (NCI). This kit is not Food and Drug Administration (FDA) approved. It is being used as a treatment determining in-vitro diagnostic device in this study.
Venetoclax: Administered orally, days 1-10, per specified dose level; every 21 days for up to 24 cycles, or until disease progression or unacceptable toxicity
VIP152: Administered intravenously, days 2 and 9, per specified dose level; every 21 days for up to 24 cycles, or until disease progression or unacceptable toxicity
Prednisone: Administered orally, days 1-10, at a dose of 100 mg; every 21 days for up to 24 cycles, or until disease progression or unacceptable toxicity
Cohort 1 Dose Escalation: participants with either refractory/relapsed (R/R) MYC-rearranged diffuse large B-cell lymphoma (DLBCL)/high-grade B-cell lymphoma (HGBCL, R/R non-germinal center B-Cell (GCB) DLBCL (no MYC rearrangement) and/or R/R peripheral T-cell lymphoma (PTCL)
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=45 Participants
|
0 Participants
n=12929 Participants
|
0 Participants
n=6349 Participants
|
0 Participants
n=4548 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=45 Participants
|
1 Participants
n=12929 Participants
|
2 Participants
n=6349 Participants
|
5 Participants
n=4548 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=45 Participants
|
2 Participants
n=12929 Participants
|
0 Participants
n=6349 Participants
|
3 Participants
n=4548 Participants
|
|
Age, Continuous
|
62.67 years
STANDARD_DEVIATION 12.42 • n=45 Participants
|
68.33 years
STANDARD_DEVIATION 12.22 • n=12929 Participants
|
43.5 years
STANDARD_DEVIATION 6.36 • n=6349 Participants
|
60 years
STANDARD_DEVIATION 14.25 • n=4548 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=45 Participants
|
0 Participants
n=12929 Participants
|
0 Participants
n=6349 Participants
|
1 Participants
n=4548 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=45 Participants
|
3 Participants
n=12929 Participants
|
2 Participants
n=6349 Participants
|
7 Participants
n=4548 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=45 Participants
|
2 Participants
n=12929 Participants
|
0 Participants
n=6349 Participants
|
2 Participants
n=4548 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=45 Participants
|
1 Participants
n=12929 Participants
|
2 Participants
n=6349 Participants
|
6 Participants
n=4548 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=45 Participants
|
0 Participants
n=12929 Participants
|
0 Participants
n=6349 Participants
|
0 Participants
n=4548 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=45 Participants
|
0 Participants
n=12929 Participants
|
0 Participants
n=6349 Participants
|
0 Participants
n=4548 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=45 Participants
|
0 Participants
n=12929 Participants
|
1 Participants
n=6349 Participants
|
1 Participants
n=4548 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=45 Participants
|
0 Participants
n=12929 Participants
|
0 Participants
n=6349 Participants
|
0 Participants
n=4548 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=45 Participants
|
1 Participants
n=12929 Participants
|
0 Participants
n=6349 Participants
|
1 Participants
n=4548 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=45 Participants
|
1 Participants
n=12929 Participants
|
0 Participants
n=6349 Participants
|
4 Participants
n=4548 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=45 Participants
|
0 Participants
n=12929 Participants
|
0 Participants
n=6349 Participants
|
0 Participants
n=4548 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=45 Participants
|
1 Participants
n=12929 Participants
|
1 Participants
n=6349 Participants
|
2 Participants
n=4548 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=45 Participants
|
3 participants
n=12929 Participants
|
2 participants
n=6349 Participants
|
8 participants
n=4548 Participants
|
PRIMARY outcome
Timeframe: 24 cycles (i.e., 72 weeks)Population: This outcome measure was not done because no participants were enrolled in the phase 2 cohort.
CR rate is defined as the percentage of participants who meet criteria for complete response (CR) as measured by the Lugano Classification Response Criteria for Non-Hodgkin lymphoma (NHL). Complete response is defined as target nodes/nodal masses that regress to \<1.5 cm in longest transverse diameter of a lesion (LDi).
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to 18 weeks.Number of non-serious adverse events (AE's) with grade was assessed by the CTCAEv5.0. A non-serious adverse event is any untoward medical occurrence that does not meet seriousness criteria. Grade 1 is mild. Grade 2 is moderate. Grade 3 is serious. Grade 4 if life-threatening.
Outcome measures
| Measure |
Cohort 2/Phase 2: Arm 2 Dose Expansion with Enitociclib (VIP152) & Venetoclax
n=3 Participants
No participants were enrolled in cohort 2/phase 2: Arm 2 dose expansion. Enitociclib (VIP152), Venetoclax, and prednisone (VVIP) - VIP152 and venetoclax at the recommended phase II dose (RP2D) with prednisone at fixed doses.
Vysis LSI MYC Break Apart Rearrangement Probe Kit: MYC rearrangement fluorescence in situ hybridization (FISH) testing is performed using the Vysis LSI MYC Break Apart Rearrangement Probe (Abbott Molecular, Inc.) in the Chromosome Pathology Section, Laboratory of Pathology, Center for Cancer Research (CCR), National Cancer Institute (NCI). This kit is not Food and Drug Administration (FDA) approved. It is being used as a treatment determining in-vitro diagnostic device in this study.
Venetoclax: Administered orally, days 1-10, per specified dose levelat the RP2D; every 21 days for up to 12 24 cycles, or until disease progression or unacceptable toxicity VIP152: Administered intravenously, days 2 and 9, per specified dose levelat the RP2D; every 21 days for up to 12 24 cycles, or until disease progression or unacceptable toxicity Prednisone: Administered orally, days 1-10, at a dose of 100 mg; every 21 days for up to 12 24 cycles, or until disease progression or unacceptable toxicity Participants with refractory/relapsed (R/R) MYC-rearranged diffuse large B-cell lymphoma (DLBCL)/high-grade B-cell lymphoma (HGBCL) for Phase 2 dose expansion.
|
Cohort 1/Phase 1: Arm 1 Dose Escalation Dose Level 2 Enitociclib(VIP152) 22.5 mg & Venetoclax 600 mg
n=3 Participants
Venitociclib (VIP152), venetoclax and prednisone (VVIP) - VIP152 and venetoclax at escalating doses with prednisone at fixed doses to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of VIP152 and venetoclax.
Vysis LSI MYC Break Apart Rearrangement Probe Kit: MYC rearrangement fluorescence in situ hybridization (FISH) testing is performed using the Vysis LSI MYC Break Apart Rearrangement Probe (Abbott Molecular, Inc.) in the Chromosome Pathology Section, Laboratory of Pathology, Center for Cancer Research (CCR), National Cancer Institute (NCI). This kit is not Food and Drug Administration (FDA) approved. It is being used as a treatment determining in-vitro diagnostic device in this study.
Venetoclax: Administered orally, days 1-10, per specified dose level; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity
VIP152: Administered intravenously, days 2 and 9, per specified dose level; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity
Prednisone: Administered orally, days 1-10, at a dose of 100 mg; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity
Cohort 1 Dose Escalation: participants with either refractory/relapsed (R/R) MYC-rearranged diffuse large B-cell lymphoma (DLBCL)/high-grade B-cell lymphoma (HGBCL, R/R non-germinal center B-Cell (GCB) DLBCL (no MYC rearrangement) and/or R/R peripheral T-cell lymphoma (PTCL)
|
Cohort 1/Phase 1: Arm 1 Dose Escalation Dose Level 3 Enitociclib (VIP152) 30 mg & Venetoclax 600 mg
n=2 Participants
Enitociclib (VIP152), Venetoclax and prednisone (VVIP) - VIP152 and venetoclax at escalating doses with prednisone at fixed doses to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of VIP152 and venetoclax.
Vysis LSI MYC Break Apart Rearrangement Probe Kit: MYC rearrangement fluorescence in situ hybridization (FISH) testing is performed using the Vysis LSI MYC Break Apart Rearrangement Probe (Abbott Molecular, Inc.) in the Chromosome Pathology Section, Laboratory of Pathology, Center for Cancer Research (CCR), National Cancer Institute (NCI). This kit is not Food and Drug Administration (FDA) approved. It is being used as a treatment determining in-vitro diagnostic device in this study.
Venetoclax: Administered orally, days 1-10, per specified dose level; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity
VIP152: Administered intravenously, days 2 and 9, per specified dose level; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity
Prednisone: Administered orally, days 1-10, at a dose of 100 mg; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity
Cohort 1 Dose Escalation: participants with either refractory/relapsed (R/R) MYC-rearranged diffuse large B-cell lymphoma (DLBCL)/high-grade B-cell lymphoma (HGBCL, R/R non-germinal center B-Cell (GCB) DLBCL (no MYC rearrangement) and/or R/R peripheral T-cell lymphoma (PTCL)
|
|---|---|---|---|
|
Phase 1: Number of Solicited and/or Non-solicited Non-serious Adverse Events (AE's) With Grade
Grade 1 Alanine aminotransferase increased
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
|
Phase 1: Number of Solicited and/or Non-solicited Non-serious Adverse Events (AE's) With Grade
Grade 1 Alkaline phosphatase increased
|
2 adverse events
|
4 adverse events
|
1 adverse events
|
|
Phase 1: Number of Solicited and/or Non-solicited Non-serious Adverse Events (AE's) With Grade
Grade 1 Anemia
|
9 adverse events
|
7 adverse events
|
3 adverse events
|
|
Phase 1: Number of Solicited and/or Non-solicited Non-serious Adverse Events (AE's) With Grade
Grade 1 Aspartate aminotransferase increased
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
|
Phase 1: Number of Solicited and/or Non-solicited Non-serious Adverse Events (AE's) With Grade
Grade 1 Blood bilirubin increased
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
|
Phase 1: Number of Solicited and/or Non-solicited Non-serious Adverse Events (AE's) With Grade
Grade 1 Bone pain
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
|
Phase 1: Number of Solicited and/or Non-solicited Non-serious Adverse Events (AE's) With Grade
Grade 1 Constipation
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
|
Phase 1: Number of Solicited and/or Non-solicited Non-serious Adverse Events (AE's) With Grade
Grade 1 Creatinine increased
|
0 adverse events
|
0 adverse events
|
2 adverse events
|
|
Phase 1: Number of Solicited and/or Non-solicited Non-serious Adverse Events (AE's) With Grade
Grade 1 Flatulence
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
|
Phase 1: Number of Solicited and/or Non-solicited Non-serious Adverse Events (AE's) With Grade
Grade 1 Cytomegalovirus infection reactivation
|
1 adverse events
|
4 adverse events
|
0 adverse events
|
|
Phase 1: Number of Solicited and/or Non-solicited Non-serious Adverse Events (AE's) With Grade
Grade 1 Headache
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
|
Phase 1: Number of Solicited and/or Non-solicited Non-serious Adverse Events (AE's) With Grade
Grade 1 Diarrhea
|
1 adverse events
|
2 adverse events
|
0 adverse events
|
|
Phase 1: Number of Solicited and/or Non-solicited Non-serious Adverse Events (AE's) With Grade
Grade 1 Edema limbs
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
|
Phase 1: Number of Solicited and/or Non-solicited Non-serious Adverse Events (AE's) With Grade
Grade 1 Fatigue
|
2 adverse events
|
0 adverse events
|
0 adverse events
|
|
Phase 1: Number of Solicited and/or Non-solicited Non-serious Adverse Events (AE's) With Grade
Grade 1 Skin and subcutaneous tissue disorders - tinea corporis
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
|
Phase 1: Number of Solicited and/or Non-solicited Non-serious Adverse Events (AE's) With Grade
Grade 2 Anemia
|
6 adverse events
|
6 adverse events
|
1 adverse events
|
|
Phase 1: Number of Solicited and/or Non-solicited Non-serious Adverse Events (AE's) With Grade
Grade 2 Back pain
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
|
Phase 1: Number of Solicited and/or Non-solicited Non-serious Adverse Events (AE's) With Grade
Grade 2 Creatinine increased
|
0 adverse events
|
0 adverse events
|
2 adverse events
|
|
Phase 1: Number of Solicited and/or Non-solicited Non-serious Adverse Events (AE's) With Grade
Grade 2 Hyperphosphatemia
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
|
Phase 1: Number of Solicited and/or Non-solicited Non-serious Adverse Events (AE's) With Grade
Grade 2 Hypokalemia
|
5 adverse events
|
4 adverse events
|
1 adverse events
|
|
Phase 1: Number of Solicited and/or Non-solicited Non-serious Adverse Events (AE's) With Grade
Grade 2 Neutrophil count decreased
|
3 adverse events
|
4 adverse events
|
0 adverse events
|
|
Phase 1: Number of Solicited and/or Non-solicited Non-serious Adverse Events (AE's) With Grade
Grade 2 Pain in extremity
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
|
Phase 1: Number of Solicited and/or Non-solicited Non-serious Adverse Events (AE's) With Grade
Grade 2 Platelet count decreased
|
0 adverse events
|
2 adverse events
|
1 adverse events
|
|
Phase 1: Number of Solicited and/or Non-solicited Non-serious Adverse Events (AE's) With Grade
Grade 2 Skin infection
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
|
Phase 1: Number of Solicited and/or Non-solicited Non-serious Adverse Events (AE's) With Grade
Grade 3 Hypokalemia
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
|
Phase 1: Number of Solicited and/or Non-solicited Non-serious Adverse Events (AE's) With Grade
Grade 3 Neutrophil count decreased
|
2 adverse events
|
1 adverse events
|
0 adverse events
|
|
Phase 1: Number of Solicited and/or Non-solicited Non-serious Adverse Events (AE's) With Grade
Grade 3 Platelet count decreased
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
|
Phase 1: Number of Solicited and/or Non-solicited Non-serious Adverse Events (AE's) With Grade
Grade 4 Neutrophil count decreased
|
0 adverse events
|
4 adverse events
|
1 adverse events
|
|
Phase 1: Number of Solicited and/or Non-solicited Non-serious Adverse Events (AE's) With Grade
Grade 1 Hypokalemia
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
|
Phase 1: Number of Solicited and/or Non-solicited Non-serious Adverse Events (AE's) With Grade
Grade 1 Hypomagnesemia
|
3 adverse events
|
4 adverse events
|
0 adverse events
|
|
Phase 1: Number of Solicited and/or Non-solicited Non-serious Adverse Events (AE's) With Grade
Grade 1 Insomnia
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
|
Phase 1: Number of Solicited and/or Non-solicited Non-serious Adverse Events (AE's) With Grade
Grade 1 Nausea
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
|
Phase 1: Number of Solicited and/or Non-solicited Non-serious Adverse Events (AE's) With Grade
Grade 1 Neutrophil count decreased
|
0 adverse events
|
4 adverse events
|
1 adverse events
|
|
Phase 1: Number of Solicited and/or Non-solicited Non-serious Adverse Events (AE's) With Grade
Grade 1 Pain in extremity
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
|
Phase 1: Number of Solicited and/or Non-solicited Non-serious Adverse Events (AE's) With Grade
Grade 1 Platelet count decreased
|
7 adverse events
|
9 adverse events
|
4 adverse events
|
|
Phase 1: Number of Solicited and/or Non-solicited Non-serious Adverse Events (AE's) With Grade
Grade 1 Rash maculopapular
|
1 adverse events
|
1 adverse events
|
0 adverse events
|
PRIMARY outcome
Timeframe: Up to 18 weeks.Number of serious adverse events (SAE's) with grade was assessed by the CTCAEv5.0. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. Grade 1 is mild. Grade 2 is moderate. Grade 3 is severe. Grade 4 is life-threatening. Grade 5 is fatal.
Outcome measures
| Measure |
Cohort 2/Phase 2: Arm 2 Dose Expansion with Enitociclib (VIP152) & Venetoclax
n=3 Participants
No participants were enrolled in cohort 2/phase 2: Arm 2 dose expansion. Enitociclib (VIP152), Venetoclax, and prednisone (VVIP) - VIP152 and venetoclax at the recommended phase II dose (RP2D) with prednisone at fixed doses.
Vysis LSI MYC Break Apart Rearrangement Probe Kit: MYC rearrangement fluorescence in situ hybridization (FISH) testing is performed using the Vysis LSI MYC Break Apart Rearrangement Probe (Abbott Molecular, Inc.) in the Chromosome Pathology Section, Laboratory of Pathology, Center for Cancer Research (CCR), National Cancer Institute (NCI). This kit is not Food and Drug Administration (FDA) approved. It is being used as a treatment determining in-vitro diagnostic device in this study.
Venetoclax: Administered orally, days 1-10, per specified dose levelat the RP2D; every 21 days for up to 12 24 cycles, or until disease progression or unacceptable toxicity VIP152: Administered intravenously, days 2 and 9, per specified dose levelat the RP2D; every 21 days for up to 12 24 cycles, or until disease progression or unacceptable toxicity Prednisone: Administered orally, days 1-10, at a dose of 100 mg; every 21 days for up to 12 24 cycles, or until disease progression or unacceptable toxicity Participants with refractory/relapsed (R/R) MYC-rearranged diffuse large B-cell lymphoma (DLBCL)/high-grade B-cell lymphoma (HGBCL) for Phase 2 dose expansion.
|
Cohort 1/Phase 1: Arm 1 Dose Escalation Dose Level 2 Enitociclib(VIP152) 22.5 mg & Venetoclax 600 mg
n=3 Participants
Venitociclib (VIP152), venetoclax and prednisone (VVIP) - VIP152 and venetoclax at escalating doses with prednisone at fixed doses to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of VIP152 and venetoclax.
Vysis LSI MYC Break Apart Rearrangement Probe Kit: MYC rearrangement fluorescence in situ hybridization (FISH) testing is performed using the Vysis LSI MYC Break Apart Rearrangement Probe (Abbott Molecular, Inc.) in the Chromosome Pathology Section, Laboratory of Pathology, Center for Cancer Research (CCR), National Cancer Institute (NCI). This kit is not Food and Drug Administration (FDA) approved. It is being used as a treatment determining in-vitro diagnostic device in this study.
Venetoclax: Administered orally, days 1-10, per specified dose level; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity
VIP152: Administered intravenously, days 2 and 9, per specified dose level; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity
Prednisone: Administered orally, days 1-10, at a dose of 100 mg; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity
Cohort 1 Dose Escalation: participants with either refractory/relapsed (R/R) MYC-rearranged diffuse large B-cell lymphoma (DLBCL)/high-grade B-cell lymphoma (HGBCL, R/R non-germinal center B-Cell (GCB) DLBCL (no MYC rearrangement) and/or R/R peripheral T-cell lymphoma (PTCL)
|
Cohort 1/Phase 1: Arm 1 Dose Escalation Dose Level 3 Enitociclib (VIP152) 30 mg & Venetoclax 600 mg
n=2 Participants
Enitociclib (VIP152), Venetoclax and prednisone (VVIP) - VIP152 and venetoclax at escalating doses with prednisone at fixed doses to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of VIP152 and venetoclax.
Vysis LSI MYC Break Apart Rearrangement Probe Kit: MYC rearrangement fluorescence in situ hybridization (FISH) testing is performed using the Vysis LSI MYC Break Apart Rearrangement Probe (Abbott Molecular, Inc.) in the Chromosome Pathology Section, Laboratory of Pathology, Center for Cancer Research (CCR), National Cancer Institute (NCI). This kit is not Food and Drug Administration (FDA) approved. It is being used as a treatment determining in-vitro diagnostic device in this study.
Venetoclax: Administered orally, days 1-10, per specified dose level; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity
VIP152: Administered intravenously, days 2 and 9, per specified dose level; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity
Prednisone: Administered orally, days 1-10, at a dose of 100 mg; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity
Cohort 1 Dose Escalation: participants with either refractory/relapsed (R/R) MYC-rearranged diffuse large B-cell lymphoma (DLBCL)/high-grade B-cell lymphoma (HGBCL, R/R non-germinal center B-Cell (GCB) DLBCL (no MYC rearrangement) and/or R/R peripheral T-cell lymphoma (PTCL)
|
|---|---|---|---|
|
Phase 1: Number of Solicited and/or Unsolicited Serious Adverse Events (SAE's) With Grade
Grade 2 Lymph node pain
|
0 Adverse events
|
1 Adverse events
|
0 Adverse events
|
|
Phase 1: Number of Solicited and/or Unsolicited Serious Adverse Events (SAE's) With Grade
Grade 3 Alanine aminotransferase increased
|
0 Adverse events
|
0 Adverse events
|
1 Adverse events
|
|
Phase 1: Number of Solicited and/or Unsolicited Serious Adverse Events (SAE's) With Grade
Grade 3 Aspartate aminotransferase increased
|
0 Adverse events
|
0 Adverse events
|
1 Adverse events
|
PRIMARY outcome
Timeframe: First 22 days (i.e., cycle 1, day 1 to cycle 2, day 1 pre-dose)The MTD/RP2D is the dose level at which no more than 1 of up to 6 participants experience dose limiting toxicity (DLT) during the DLT evaluation window(s), or the dose below that at which at least 2 (of ≤6) participants have DLT. A DLT (dose-limiting toxicity) is defined as a grade 3 or higher adverse event (AE) that occurs in the dose-escalation cohort within the first 22 days after initiation of VVIP (i.e., Cycle 1, Day 1 to Cycle 2, Day 1 pre-dose) and is considered related to study drug (i.e., VIP152, venetoclax, and/or prednisone) or a treatment delay of cycle 2 of \> 7 days for hematologic or nonhematologic toxicities.
Outcome measures
| Measure |
Cohort 2/Phase 2: Arm 2 Dose Expansion with Enitociclib (VIP152) & Venetoclax
n=8 Participants
No participants were enrolled in cohort 2/phase 2: Arm 2 dose expansion. Enitociclib (VIP152), Venetoclax, and prednisone (VVIP) - VIP152 and venetoclax at the recommended phase II dose (RP2D) with prednisone at fixed doses.
Vysis LSI MYC Break Apart Rearrangement Probe Kit: MYC rearrangement fluorescence in situ hybridization (FISH) testing is performed using the Vysis LSI MYC Break Apart Rearrangement Probe (Abbott Molecular, Inc.) in the Chromosome Pathology Section, Laboratory of Pathology, Center for Cancer Research (CCR), National Cancer Institute (NCI). This kit is not Food and Drug Administration (FDA) approved. It is being used as a treatment determining in-vitro diagnostic device in this study.
Venetoclax: Administered orally, days 1-10, per specified dose levelat the RP2D; every 21 days for up to 12 24 cycles, or until disease progression or unacceptable toxicity VIP152: Administered intravenously, days 2 and 9, per specified dose levelat the RP2D; every 21 days for up to 12 24 cycles, or until disease progression or unacceptable toxicity Prednisone: Administered orally, days 1-10, at a dose of 100 mg; every 21 days for up to 12 24 cycles, or until disease progression or unacceptable toxicity Participants with refractory/relapsed (R/R) MYC-rearranged diffuse large B-cell lymphoma (DLBCL)/high-grade B-cell lymphoma (HGBCL) for Phase 2 dose expansion.
|
Cohort 1/Phase 1: Arm 1 Dose Escalation Dose Level 2 Enitociclib(VIP152) 22.5 mg & Venetoclax 600 mg
Venitociclib (VIP152), venetoclax and prednisone (VVIP) - VIP152 and venetoclax at escalating doses with prednisone at fixed doses to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of VIP152 and venetoclax.
Vysis LSI MYC Break Apart Rearrangement Probe Kit: MYC rearrangement fluorescence in situ hybridization (FISH) testing is performed using the Vysis LSI MYC Break Apart Rearrangement Probe (Abbott Molecular, Inc.) in the Chromosome Pathology Section, Laboratory of Pathology, Center for Cancer Research (CCR), National Cancer Institute (NCI). This kit is not Food and Drug Administration (FDA) approved. It is being used as a treatment determining in-vitro diagnostic device in this study.
Venetoclax: Administered orally, days 1-10, per specified dose level; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity
VIP152: Administered intravenously, days 2 and 9, per specified dose level; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity
Prednisone: Administered orally, days 1-10, at a dose of 100 mg; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity
Cohort 1 Dose Escalation: participants with either refractory/relapsed (R/R) MYC-rearranged diffuse large B-cell lymphoma (DLBCL)/high-grade B-cell lymphoma (HGBCL, R/R non-germinal center B-Cell (GCB) DLBCL (no MYC rearrangement) and/or R/R peripheral T-cell lymphoma (PTCL)
|
Cohort 1/Phase 1: Arm 1 Dose Escalation Dose Level 3 Enitociclib (VIP152) 30 mg & Venetoclax 600 mg
Enitociclib (VIP152), Venetoclax and prednisone (VVIP) - VIP152 and venetoclax at escalating doses with prednisone at fixed doses to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of VIP152 and venetoclax.
Vysis LSI MYC Break Apart Rearrangement Probe Kit: MYC rearrangement fluorescence in situ hybridization (FISH) testing is performed using the Vysis LSI MYC Break Apart Rearrangement Probe (Abbott Molecular, Inc.) in the Chromosome Pathology Section, Laboratory of Pathology, Center for Cancer Research (CCR), National Cancer Institute (NCI). This kit is not Food and Drug Administration (FDA) approved. It is being used as a treatment determining in-vitro diagnostic device in this study.
Venetoclax: Administered orally, days 1-10, per specified dose level; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity
VIP152: Administered intravenously, days 2 and 9, per specified dose level; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity
Prednisone: Administered orally, days 1-10, at a dose of 100 mg; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity
Cohort 1 Dose Escalation: participants with either refractory/relapsed (R/R) MYC-rearranged diffuse large B-cell lymphoma (DLBCL)/high-grade B-cell lymphoma (HGBCL, R/R non-germinal center B-Cell (GCB) DLBCL (no MYC rearrangement) and/or R/R peripheral T-cell lymphoma (PTCL)
|
|---|---|---|---|
|
Phase 1: Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D)
|
NA mg
MTD/RP2D was not found because the study was prematurely closed.
|
—
|
—
|
PRIMARY outcome
Timeframe: First 22 days (i.e., cycle 1, day 1 to cycle 2, day 1 pre-dose)A DLT (dose-limiting toxicity) is defined as a grade 3 or higher adverse event (AE) that occurs in the dose-escalation cohort within the first 22 days after initiation of VVIP (i.e., Cycle 1, Day 1 to Cycle 2, Day 1 pre-dose) and is considered related to study drug (i.e., VIP152, venetoclax, and/or prednisone) or a treatment delay of cycle 2 of \> 7 days for hematologic or nonhematologic toxicities.
Outcome measures
| Measure |
Cohort 2/Phase 2: Arm 2 Dose Expansion with Enitociclib (VIP152) & Venetoclax
n=3 Participants
No participants were enrolled in cohort 2/phase 2: Arm 2 dose expansion. Enitociclib (VIP152), Venetoclax, and prednisone (VVIP) - VIP152 and venetoclax at the recommended phase II dose (RP2D) with prednisone at fixed doses.
Vysis LSI MYC Break Apart Rearrangement Probe Kit: MYC rearrangement fluorescence in situ hybridization (FISH) testing is performed using the Vysis LSI MYC Break Apart Rearrangement Probe (Abbott Molecular, Inc.) in the Chromosome Pathology Section, Laboratory of Pathology, Center for Cancer Research (CCR), National Cancer Institute (NCI). This kit is not Food and Drug Administration (FDA) approved. It is being used as a treatment determining in-vitro diagnostic device in this study.
Venetoclax: Administered orally, days 1-10, per specified dose levelat the RP2D; every 21 days for up to 12 24 cycles, or until disease progression or unacceptable toxicity VIP152: Administered intravenously, days 2 and 9, per specified dose levelat the RP2D; every 21 days for up to 12 24 cycles, or until disease progression or unacceptable toxicity Prednisone: Administered orally, days 1-10, at a dose of 100 mg; every 21 days for up to 12 24 cycles, or until disease progression or unacceptable toxicity Participants with refractory/relapsed (R/R) MYC-rearranged diffuse large B-cell lymphoma (DLBCL)/high-grade B-cell lymphoma (HGBCL) for Phase 2 dose expansion.
|
Cohort 1/Phase 1: Arm 1 Dose Escalation Dose Level 2 Enitociclib(VIP152) 22.5 mg & Venetoclax 600 mg
n=3 Participants
Venitociclib (VIP152), venetoclax and prednisone (VVIP) - VIP152 and venetoclax at escalating doses with prednisone at fixed doses to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of VIP152 and venetoclax.
Vysis LSI MYC Break Apart Rearrangement Probe Kit: MYC rearrangement fluorescence in situ hybridization (FISH) testing is performed using the Vysis LSI MYC Break Apart Rearrangement Probe (Abbott Molecular, Inc.) in the Chromosome Pathology Section, Laboratory of Pathology, Center for Cancer Research (CCR), National Cancer Institute (NCI). This kit is not Food and Drug Administration (FDA) approved. It is being used as a treatment determining in-vitro diagnostic device in this study.
Venetoclax: Administered orally, days 1-10, per specified dose level; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity
VIP152: Administered intravenously, days 2 and 9, per specified dose level; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity
Prednisone: Administered orally, days 1-10, at a dose of 100 mg; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity
Cohort 1 Dose Escalation: participants with either refractory/relapsed (R/R) MYC-rearranged diffuse large B-cell lymphoma (DLBCL)/high-grade B-cell lymphoma (HGBCL, R/R non-germinal center B-Cell (GCB) DLBCL (no MYC rearrangement) and/or R/R peripheral T-cell lymphoma (PTCL)
|
Cohort 1/Phase 1: Arm 1 Dose Escalation Dose Level 3 Enitociclib (VIP152) 30 mg & Venetoclax 600 mg
n=2 Participants
Enitociclib (VIP152), Venetoclax and prednisone (VVIP) - VIP152 and venetoclax at escalating doses with prednisone at fixed doses to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of VIP152 and venetoclax.
Vysis LSI MYC Break Apart Rearrangement Probe Kit: MYC rearrangement fluorescence in situ hybridization (FISH) testing is performed using the Vysis LSI MYC Break Apart Rearrangement Probe (Abbott Molecular, Inc.) in the Chromosome Pathology Section, Laboratory of Pathology, Center for Cancer Research (CCR), National Cancer Institute (NCI). This kit is not Food and Drug Administration (FDA) approved. It is being used as a treatment determining in-vitro diagnostic device in this study.
Venetoclax: Administered orally, days 1-10, per specified dose level; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity
VIP152: Administered intravenously, days 2 and 9, per specified dose level; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity
Prednisone: Administered orally, days 1-10, at a dose of 100 mg; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity
Cohort 1 Dose Escalation: participants with either refractory/relapsed (R/R) MYC-rearranged diffuse large B-cell lymphoma (DLBCL)/high-grade B-cell lymphoma (HGBCL, R/R non-germinal center B-Cell (GCB) DLBCL (no MYC rearrangement) and/or R/R peripheral T-cell lymphoma (PTCL)
|
|---|---|---|---|
|
Phase 1: Number of Participants With Grade 4 Neutropenia Dose-Limiting Toxicity (DLT)
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Assessed from date of study enrollment until time of disease relapse, disease progression, death, or last follow-up, whichever comes first, up to 8 monthsPFS is defined as the duration of time from the date of study enrollment until the date of disease relapse, disease progression, death, or last follow-up, whichever occurs first, using the Kaplan-Meier method. Response was assessed by the Lugano Classification Response Criteria for Non-Hodgkin lymphoma (NHL). Disease progression is defined as an increase of ≥ 50% from the product of the perpendicular diameter (PPD) nadir and an increase in longest transverse diameter of a lesion (LDi) or shortest axis perpendicular diameter (SDi) from nadir of \>0.5 cm for lesions \<2 cm or \>1.0 cm for lesions \>2 cm.
Outcome measures
| Measure |
Cohort 2/Phase 2: Arm 2 Dose Expansion with Enitociclib (VIP152) & Venetoclax
n=3 Participants
No participants were enrolled in cohort 2/phase 2: Arm 2 dose expansion. Enitociclib (VIP152), Venetoclax, and prednisone (VVIP) - VIP152 and venetoclax at the recommended phase II dose (RP2D) with prednisone at fixed doses.
Vysis LSI MYC Break Apart Rearrangement Probe Kit: MYC rearrangement fluorescence in situ hybridization (FISH) testing is performed using the Vysis LSI MYC Break Apart Rearrangement Probe (Abbott Molecular, Inc.) in the Chromosome Pathology Section, Laboratory of Pathology, Center for Cancer Research (CCR), National Cancer Institute (NCI). This kit is not Food and Drug Administration (FDA) approved. It is being used as a treatment determining in-vitro diagnostic device in this study.
Venetoclax: Administered orally, days 1-10, per specified dose levelat the RP2D; every 21 days for up to 12 24 cycles, or until disease progression or unacceptable toxicity VIP152: Administered intravenously, days 2 and 9, per specified dose levelat the RP2D; every 21 days for up to 12 24 cycles, or until disease progression or unacceptable toxicity Prednisone: Administered orally, days 1-10, at a dose of 100 mg; every 21 days for up to 12 24 cycles, or until disease progression or unacceptable toxicity Participants with refractory/relapsed (R/R) MYC-rearranged diffuse large B-cell lymphoma (DLBCL)/high-grade B-cell lymphoma (HGBCL) for Phase 2 dose expansion.
|
Cohort 1/Phase 1: Arm 1 Dose Escalation Dose Level 2 Enitociclib(VIP152) 22.5 mg & Venetoclax 600 mg
n=3 Participants
Venitociclib (VIP152), venetoclax and prednisone (VVIP) - VIP152 and venetoclax at escalating doses with prednisone at fixed doses to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of VIP152 and venetoclax.
Vysis LSI MYC Break Apart Rearrangement Probe Kit: MYC rearrangement fluorescence in situ hybridization (FISH) testing is performed using the Vysis LSI MYC Break Apart Rearrangement Probe (Abbott Molecular, Inc.) in the Chromosome Pathology Section, Laboratory of Pathology, Center for Cancer Research (CCR), National Cancer Institute (NCI). This kit is not Food and Drug Administration (FDA) approved. It is being used as a treatment determining in-vitro diagnostic device in this study.
Venetoclax: Administered orally, days 1-10, per specified dose level; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity
VIP152: Administered intravenously, days 2 and 9, per specified dose level; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity
Prednisone: Administered orally, days 1-10, at a dose of 100 mg; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity
Cohort 1 Dose Escalation: participants with either refractory/relapsed (R/R) MYC-rearranged diffuse large B-cell lymphoma (DLBCL)/high-grade B-cell lymphoma (HGBCL, R/R non-germinal center B-Cell (GCB) DLBCL (no MYC rearrangement) and/or R/R peripheral T-cell lymphoma (PTCL)
|
Cohort 1/Phase 1: Arm 1 Dose Escalation Dose Level 3 Enitociclib (VIP152) 30 mg & Venetoclax 600 mg
n=2 Participants
Enitociclib (VIP152), Venetoclax and prednisone (VVIP) - VIP152 and venetoclax at escalating doses with prednisone at fixed doses to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of VIP152 and venetoclax.
Vysis LSI MYC Break Apart Rearrangement Probe Kit: MYC rearrangement fluorescence in situ hybridization (FISH) testing is performed using the Vysis LSI MYC Break Apart Rearrangement Probe (Abbott Molecular, Inc.) in the Chromosome Pathology Section, Laboratory of Pathology, Center for Cancer Research (CCR), National Cancer Institute (NCI). This kit is not Food and Drug Administration (FDA) approved. It is being used as a treatment determining in-vitro diagnostic device in this study.
Venetoclax: Administered orally, days 1-10, per specified dose level; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity
VIP152: Administered intravenously, days 2 and 9, per specified dose level; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity
Prednisone: Administered orally, days 1-10, at a dose of 100 mg; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity
Cohort 1 Dose Escalation: participants with either refractory/relapsed (R/R) MYC-rearranged diffuse large B-cell lymphoma (DLBCL)/high-grade B-cell lymphoma (HGBCL, R/R non-germinal center B-Cell (GCB) DLBCL (no MYC rearrangement) and/or R/R peripheral T-cell lymphoma (PTCL)
|
|---|---|---|---|
|
Phase 1: Progression-free Survival (PFS)
|
1.48 Months
Interval 0.49 to
The confidence intervals (CI) are generated from the Brookmeyer-Crowley method, where if the estimate of a limit of a generated CI does not cross the median then it is reported as not estimable.
|
4.14 Months
Interval 2.99 to
The confidence intervals (CI) are generated from the Brookmeyer-Crowley method, where if the estimate of a limit of a generated CI does not cross the median then it is reported as not estimable.
|
4.11 Months
Interval 2.14 to
The confidence intervals (CI) are generated from the Brookmeyer-Crowley method, where if the estimate of a limit of a generated CI does not cross the median then it is reported as not estimable.
|
SECONDARY outcome
Timeframe: Time from the date of study enrollment during therapy, after completion of therapy from initiation of therapy to first response, up to 5 monthsTTR is defined as the time from the start of the treatment until time of first objective response using the Kaplan-Meier method. Median, assessed during therapy and after completion of therapy from initiation of therapy to first response every (q)3, 4, 6 and 12 months for post-treatment years 1, 2, 3, and 4-5, respectively, for up to 5 years after the last participant has enrolled on study. Response was measured by the Lugano Classification Response Criteria for Non-Hodgkin lymphoma (NHL). Complete response is target nodes/nodal masses that regress to \<1.5 cm in longest transverse diameter of a lesion. Partial response is ≥ 50% decrease in sum of the product of the perpendicular diameters for multiple lesions (SPD) of up to 6 target measurable nodes and extranodal sites. Disease progression is an increase by ≥ 50% from progressive disease progression (PPD) nadir and an increase in longest transverse diameter of a lesion (LDi) or shortest axis perpendicular diameter (SDi) from nadir.
Outcome measures
| Measure |
Cohort 2/Phase 2: Arm 2 Dose Expansion with Enitociclib (VIP152) & Venetoclax
n=3 Participants
No participants were enrolled in cohort 2/phase 2: Arm 2 dose expansion. Enitociclib (VIP152), Venetoclax, and prednisone (VVIP) - VIP152 and venetoclax at the recommended phase II dose (RP2D) with prednisone at fixed doses.
Vysis LSI MYC Break Apart Rearrangement Probe Kit: MYC rearrangement fluorescence in situ hybridization (FISH) testing is performed using the Vysis LSI MYC Break Apart Rearrangement Probe (Abbott Molecular, Inc.) in the Chromosome Pathology Section, Laboratory of Pathology, Center for Cancer Research (CCR), National Cancer Institute (NCI). This kit is not Food and Drug Administration (FDA) approved. It is being used as a treatment determining in-vitro diagnostic device in this study.
Venetoclax: Administered orally, days 1-10, per specified dose levelat the RP2D; every 21 days for up to 12 24 cycles, or until disease progression or unacceptable toxicity VIP152: Administered intravenously, days 2 and 9, per specified dose levelat the RP2D; every 21 days for up to 12 24 cycles, or until disease progression or unacceptable toxicity Prednisone: Administered orally, days 1-10, at a dose of 100 mg; every 21 days for up to 12 24 cycles, or until disease progression or unacceptable toxicity Participants with refractory/relapsed (R/R) MYC-rearranged diffuse large B-cell lymphoma (DLBCL)/high-grade B-cell lymphoma (HGBCL) for Phase 2 dose expansion.
|
Cohort 1/Phase 1: Arm 1 Dose Escalation Dose Level 2 Enitociclib(VIP152) 22.5 mg & Venetoclax 600 mg
n=3 Participants
Venitociclib (VIP152), venetoclax and prednisone (VVIP) - VIP152 and venetoclax at escalating doses with prednisone at fixed doses to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of VIP152 and venetoclax.
Vysis LSI MYC Break Apart Rearrangement Probe Kit: MYC rearrangement fluorescence in situ hybridization (FISH) testing is performed using the Vysis LSI MYC Break Apart Rearrangement Probe (Abbott Molecular, Inc.) in the Chromosome Pathology Section, Laboratory of Pathology, Center for Cancer Research (CCR), National Cancer Institute (NCI). This kit is not Food and Drug Administration (FDA) approved. It is being used as a treatment determining in-vitro diagnostic device in this study.
Venetoclax: Administered orally, days 1-10, per specified dose level; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity
VIP152: Administered intravenously, days 2 and 9, per specified dose level; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity
Prednisone: Administered orally, days 1-10, at a dose of 100 mg; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity
Cohort 1 Dose Escalation: participants with either refractory/relapsed (R/R) MYC-rearranged diffuse large B-cell lymphoma (DLBCL)/high-grade B-cell lymphoma (HGBCL, R/R non-germinal center B-Cell (GCB) DLBCL (no MYC rearrangement) and/or R/R peripheral T-cell lymphoma (PTCL)
|
Cohort 1/Phase 1: Arm 1 Dose Escalation Dose Level 3 Enitociclib (VIP152) 30 mg & Venetoclax 600 mg
n=2 Participants
Enitociclib (VIP152), Venetoclax and prednisone (VVIP) - VIP152 and venetoclax at escalating doses with prednisone at fixed doses to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of VIP152 and venetoclax.
Vysis LSI MYC Break Apart Rearrangement Probe Kit: MYC rearrangement fluorescence in situ hybridization (FISH) testing is performed using the Vysis LSI MYC Break Apart Rearrangement Probe (Abbott Molecular, Inc.) in the Chromosome Pathology Section, Laboratory of Pathology, Center for Cancer Research (CCR), National Cancer Institute (NCI). This kit is not Food and Drug Administration (FDA) approved. It is being used as a treatment determining in-vitro diagnostic device in this study.
Venetoclax: Administered orally, days 1-10, per specified dose level; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity
VIP152: Administered intravenously, days 2 and 9, per specified dose level; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity
Prednisone: Administered orally, days 1-10, at a dose of 100 mg; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity
Cohort 1 Dose Escalation: participants with either refractory/relapsed (R/R) MYC-rearranged diffuse large B-cell lymphoma (DLBCL)/high-grade B-cell lymphoma (HGBCL, R/R non-germinal center B-Cell (GCB) DLBCL (no MYC rearrangement) and/or R/R peripheral T-cell lymphoma (PTCL)
|
|---|---|---|---|
|
Phase 1: Time to Response (TTR)
|
3.45 Months
The confidence intervals (CI) are generated from the Brookmeyer-Crowley method, where if the estimate of a limit of a generated CI does not cross the median then it is reported as not estimable.
|
0.69 Months
Interval 0.66 to
The confidence intervals (CI) are generated from the Brookmeyer-Crowley method, where if the estimate of a limit of a generated CI does not cross the median then it is reported as not estimable.
|
NA Months
Median and 95% confidence interval is not estimable because not evaluable since no responses.
|
SECONDARY outcome
Timeframe: Time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 5 monthsDOR is defined as the time measurement criteria are met for complete response (CR) or partial response (PR) (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented using the Kaplan-Meier method. Response was measured by the Lugano Classification Response Criteria for Non-Hodgkin lymphoma (NHL). Complete response is target nodes/nodal masses that regress to \<1.5 cm in longest transverse diameter of a lesion (LDi). Partial response is ≥ 50% decrease in sum of the product of the perpendicular diameters for multiple lesions (SPD) of up to 6 target measurable nodes and extranodal sites. Disease progression is an increase by ≥ 50% from progressive disease progression (PPD) nadir and an increase in longest transverse diameter of a lesion (LDi) or shortest axis perpendicular diameter (SDi) from nadir of \>0.5 cm for lesions \<2 cm or \>1.0 cm for lesions \>2 cm.
Outcome measures
| Measure |
Cohort 2/Phase 2: Arm 2 Dose Expansion with Enitociclib (VIP152) & Venetoclax
n=3 Participants
No participants were enrolled in cohort 2/phase 2: Arm 2 dose expansion. Enitociclib (VIP152), Venetoclax, and prednisone (VVIP) - VIP152 and venetoclax at the recommended phase II dose (RP2D) with prednisone at fixed doses.
Vysis LSI MYC Break Apart Rearrangement Probe Kit: MYC rearrangement fluorescence in situ hybridization (FISH) testing is performed using the Vysis LSI MYC Break Apart Rearrangement Probe (Abbott Molecular, Inc.) in the Chromosome Pathology Section, Laboratory of Pathology, Center for Cancer Research (CCR), National Cancer Institute (NCI). This kit is not Food and Drug Administration (FDA) approved. It is being used as a treatment determining in-vitro diagnostic device in this study.
Venetoclax: Administered orally, days 1-10, per specified dose levelat the RP2D; every 21 days for up to 12 24 cycles, or until disease progression or unacceptable toxicity VIP152: Administered intravenously, days 2 and 9, per specified dose levelat the RP2D; every 21 days for up to 12 24 cycles, or until disease progression or unacceptable toxicity Prednisone: Administered orally, days 1-10, at a dose of 100 mg; every 21 days for up to 12 24 cycles, or until disease progression or unacceptable toxicity Participants with refractory/relapsed (R/R) MYC-rearranged diffuse large B-cell lymphoma (DLBCL)/high-grade B-cell lymphoma (HGBCL) for Phase 2 dose expansion.
|
Cohort 1/Phase 1: Arm 1 Dose Escalation Dose Level 2 Enitociclib(VIP152) 22.5 mg & Venetoclax 600 mg
n=3 Participants
Venitociclib (VIP152), venetoclax and prednisone (VVIP) - VIP152 and venetoclax at escalating doses with prednisone at fixed doses to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of VIP152 and venetoclax.
Vysis LSI MYC Break Apart Rearrangement Probe Kit: MYC rearrangement fluorescence in situ hybridization (FISH) testing is performed using the Vysis LSI MYC Break Apart Rearrangement Probe (Abbott Molecular, Inc.) in the Chromosome Pathology Section, Laboratory of Pathology, Center for Cancer Research (CCR), National Cancer Institute (NCI). This kit is not Food and Drug Administration (FDA) approved. It is being used as a treatment determining in-vitro diagnostic device in this study.
Venetoclax: Administered orally, days 1-10, per specified dose level; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity
VIP152: Administered intravenously, days 2 and 9, per specified dose level; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity
Prednisone: Administered orally, days 1-10, at a dose of 100 mg; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity
Cohort 1 Dose Escalation: participants with either refractory/relapsed (R/R) MYC-rearranged diffuse large B-cell lymphoma (DLBCL)/high-grade B-cell lymphoma (HGBCL, R/R non-germinal center B-Cell (GCB) DLBCL (no MYC rearrangement) and/or R/R peripheral T-cell lymphoma (PTCL)
|
Cohort 1/Phase 1: Arm 1 Dose Escalation Dose Level 3 Enitociclib (VIP152) 30 mg & Venetoclax 600 mg
n=2 Participants
Enitociclib (VIP152), Venetoclax and prednisone (VVIP) - VIP152 and venetoclax at escalating doses with prednisone at fixed doses to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of VIP152 and venetoclax.
Vysis LSI MYC Break Apart Rearrangement Probe Kit: MYC rearrangement fluorescence in situ hybridization (FISH) testing is performed using the Vysis LSI MYC Break Apart Rearrangement Probe (Abbott Molecular, Inc.) in the Chromosome Pathology Section, Laboratory of Pathology, Center for Cancer Research (CCR), National Cancer Institute (NCI). This kit is not Food and Drug Administration (FDA) approved. It is being used as a treatment determining in-vitro diagnostic device in this study.
Venetoclax: Administered orally, days 1-10, per specified dose level; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity
VIP152: Administered intravenously, days 2 and 9, per specified dose level; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity
Prednisone: Administered orally, days 1-10, at a dose of 100 mg; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity
Cohort 1 Dose Escalation: participants with either refractory/relapsed (R/R) MYC-rearranged diffuse large B-cell lymphoma (DLBCL)/high-grade B-cell lymphoma (HGBCL, R/R non-germinal center B-Cell (GCB) DLBCL (no MYC rearrangement) and/or R/R peripheral T-cell lymphoma (PTCL)
|
|---|---|---|---|
|
Phase 1: Duration of Response (DOR)
Complete Response
|
NA Months
Median and 95% confidence interval cannot be calculated since none of these participants achieved a response.
|
NA Months
Median and 95% confidence interval cannot be calculated since none of these participants achieved a response.
|
NA Months
Median and 95% confidence interval cannot be calculated since neither of these participants achieved a response.
|
|
Phase 1: Duration of Response (DOR)
Partial Response
|
4.37 Months
The confidence intervals (CI) are generated from the Brookmeyer-Crowley method, where if the estimate of a limit of a generated CI does not cross the median then it is reported as not estimable.
|
3.45 Months
Interval 2.33 to
The confidence intervals (CI) are generated from the Brookmeyer-Crowley method, where if the estimate of a limit of a generated CI does not cross the median then it is reported as not estimable.
|
NA Months
Median and 95% confidence interval cannot be calculated since neither of these participants achieved a response.
|
SECONDARY outcome
Timeframe: 24 cycles (i.e., 72 weeks)ORR is defined as the proportion of participants who meet criteria for complete response (CR) or partial response (PR) as measured by the Lugano Classification Response Criteria for Non-Hodgkin lymphoma (NHL). Complete response is target nodes/nodal masses that regress to \<1.5 cm in longest transverse diameter of a lesion (LDi). Partial response is ≥ 50% decrease in sum of the product of the perpendicular diameters for multiple lesions (SPD) of up to 6 target measurable nodes and extranodal sites.
Outcome measures
| Measure |
Cohort 2/Phase 2: Arm 2 Dose Expansion with Enitociclib (VIP152) & Venetoclax
n=3 Participants
No participants were enrolled in cohort 2/phase 2: Arm 2 dose expansion. Enitociclib (VIP152), Venetoclax, and prednisone (VVIP) - VIP152 and venetoclax at the recommended phase II dose (RP2D) with prednisone at fixed doses.
Vysis LSI MYC Break Apart Rearrangement Probe Kit: MYC rearrangement fluorescence in situ hybridization (FISH) testing is performed using the Vysis LSI MYC Break Apart Rearrangement Probe (Abbott Molecular, Inc.) in the Chromosome Pathology Section, Laboratory of Pathology, Center for Cancer Research (CCR), National Cancer Institute (NCI). This kit is not Food and Drug Administration (FDA) approved. It is being used as a treatment determining in-vitro diagnostic device in this study.
Venetoclax: Administered orally, days 1-10, per specified dose levelat the RP2D; every 21 days for up to 12 24 cycles, or until disease progression or unacceptable toxicity VIP152: Administered intravenously, days 2 and 9, per specified dose levelat the RP2D; every 21 days for up to 12 24 cycles, or until disease progression or unacceptable toxicity Prednisone: Administered orally, days 1-10, at a dose of 100 mg; every 21 days for up to 12 24 cycles, or until disease progression or unacceptable toxicity Participants with refractory/relapsed (R/R) MYC-rearranged diffuse large B-cell lymphoma (DLBCL)/high-grade B-cell lymphoma (HGBCL) for Phase 2 dose expansion.
|
Cohort 1/Phase 1: Arm 1 Dose Escalation Dose Level 2 Enitociclib(VIP152) 22.5 mg & Venetoclax 600 mg
n=3 Participants
Venitociclib (VIP152), venetoclax and prednisone (VVIP) - VIP152 and venetoclax at escalating doses with prednisone at fixed doses to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of VIP152 and venetoclax.
Vysis LSI MYC Break Apart Rearrangement Probe Kit: MYC rearrangement fluorescence in situ hybridization (FISH) testing is performed using the Vysis LSI MYC Break Apart Rearrangement Probe (Abbott Molecular, Inc.) in the Chromosome Pathology Section, Laboratory of Pathology, Center for Cancer Research (CCR), National Cancer Institute (NCI). This kit is not Food and Drug Administration (FDA) approved. It is being used as a treatment determining in-vitro diagnostic device in this study.
Venetoclax: Administered orally, days 1-10, per specified dose level; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity
VIP152: Administered intravenously, days 2 and 9, per specified dose level; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity
Prednisone: Administered orally, days 1-10, at a dose of 100 mg; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity
Cohort 1 Dose Escalation: participants with either refractory/relapsed (R/R) MYC-rearranged diffuse large B-cell lymphoma (DLBCL)/high-grade B-cell lymphoma (HGBCL, R/R non-germinal center B-Cell (GCB) DLBCL (no MYC rearrangement) and/or R/R peripheral T-cell lymphoma (PTCL)
|
Cohort 1/Phase 1: Arm 1 Dose Escalation Dose Level 3 Enitociclib (VIP152) 30 mg & Venetoclax 600 mg
n=2 Participants
Enitociclib (VIP152), Venetoclax and prednisone (VVIP) - VIP152 and venetoclax at escalating doses with prednisone at fixed doses to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of VIP152 and venetoclax.
Vysis LSI MYC Break Apart Rearrangement Probe Kit: MYC rearrangement fluorescence in situ hybridization (FISH) testing is performed using the Vysis LSI MYC Break Apart Rearrangement Probe (Abbott Molecular, Inc.) in the Chromosome Pathology Section, Laboratory of Pathology, Center for Cancer Research (CCR), National Cancer Institute (NCI). This kit is not Food and Drug Administration (FDA) approved. It is being used as a treatment determining in-vitro diagnostic device in this study.
Venetoclax: Administered orally, days 1-10, per specified dose level; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity
VIP152: Administered intravenously, days 2 and 9, per specified dose level; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity
Prednisone: Administered orally, days 1-10, at a dose of 100 mg; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity
Cohort 1 Dose Escalation: participants with either refractory/relapsed (R/R) MYC-rearranged diffuse large B-cell lymphoma (DLBCL)/high-grade B-cell lymphoma (HGBCL, R/R non-germinal center B-Cell (GCB) DLBCL (no MYC rearrangement) and/or R/R peripheral T-cell lymphoma (PTCL)
|
|---|---|---|---|
|
Phase 1: Overall Response Rate (ORR)
Complete Response
|
0 Proportion of participants
Interval 0.0 to 0.708
|
0 Proportion of participants
Interval 0.0 to 0.708
|
0 Proportion of participants
Interval 0.0 to 0.842
|
|
Phase 1: Overall Response Rate (ORR)
Partial Response
|
0.3333 Proportion of participants
Interval 0.0084 to 0.9057
|
1.000 Proportion of participants
Interval 0.292 to 1.0
|
0 Proportion of participants
Interval 0.0 to 0.842
|
SECONDARY outcome
Timeframe: Assessed from the date of study enrollment until death from any cause, or last follow-up, whichever occurs first, assessed up to 5 years from study enrollmentOS is defined as the time from the date of study enrollment until death from any cause, or last follow-up, whichever occurs first, assessed using the Kaplan-Meier method.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Assessed from the date of study enrollment until time of disease relapse, disease progression, alternative therapy for lymphoma given (such as radiation), death, or last follow-up, whichever occurs first, assessed up to 8 monthsEFS is defined as the time from the date of study enrollment until time of disease relapse, disease progression, alternative therapy for lymphoma given (such as radiation), death, or last follow-up, whichever occurs first, assessed using the Kaplan-Meier method. Disease progression is an increase by ≥ 50% from progressive disease progression (PPD) nadir and an increase in longest transverse diameter of a lesion (LDi) or shortest axis perpendicular diameter (SDi) from nadir of \>0.5 cm for lesions \<2 cm or \>1.0 cm for lesions \>2 cm as assessed by the Lugano Classification Response Criteria for Non-Hodgkin lymphoma (NHL).
Outcome measures
| Measure |
Cohort 2/Phase 2: Arm 2 Dose Expansion with Enitociclib (VIP152) & Venetoclax
n=3 Participants
No participants were enrolled in cohort 2/phase 2: Arm 2 dose expansion. Enitociclib (VIP152), Venetoclax, and prednisone (VVIP) - VIP152 and venetoclax at the recommended phase II dose (RP2D) with prednisone at fixed doses.
Vysis LSI MYC Break Apart Rearrangement Probe Kit: MYC rearrangement fluorescence in situ hybridization (FISH) testing is performed using the Vysis LSI MYC Break Apart Rearrangement Probe (Abbott Molecular, Inc.) in the Chromosome Pathology Section, Laboratory of Pathology, Center for Cancer Research (CCR), National Cancer Institute (NCI). This kit is not Food and Drug Administration (FDA) approved. It is being used as a treatment determining in-vitro diagnostic device in this study.
Venetoclax: Administered orally, days 1-10, per specified dose levelat the RP2D; every 21 days for up to 12 24 cycles, or until disease progression or unacceptable toxicity VIP152: Administered intravenously, days 2 and 9, per specified dose levelat the RP2D; every 21 days for up to 12 24 cycles, or until disease progression or unacceptable toxicity Prednisone: Administered orally, days 1-10, at a dose of 100 mg; every 21 days for up to 12 24 cycles, or until disease progression or unacceptable toxicity Participants with refractory/relapsed (R/R) MYC-rearranged diffuse large B-cell lymphoma (DLBCL)/high-grade B-cell lymphoma (HGBCL) for Phase 2 dose expansion.
|
Cohort 1/Phase 1: Arm 1 Dose Escalation Dose Level 2 Enitociclib(VIP152) 22.5 mg & Venetoclax 600 mg
n=3 Participants
Venitociclib (VIP152), venetoclax and prednisone (VVIP) - VIP152 and venetoclax at escalating doses with prednisone at fixed doses to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of VIP152 and venetoclax.
Vysis LSI MYC Break Apart Rearrangement Probe Kit: MYC rearrangement fluorescence in situ hybridization (FISH) testing is performed using the Vysis LSI MYC Break Apart Rearrangement Probe (Abbott Molecular, Inc.) in the Chromosome Pathology Section, Laboratory of Pathology, Center for Cancer Research (CCR), National Cancer Institute (NCI). This kit is not Food and Drug Administration (FDA) approved. It is being used as a treatment determining in-vitro diagnostic device in this study.
Venetoclax: Administered orally, days 1-10, per specified dose level; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity
VIP152: Administered intravenously, days 2 and 9, per specified dose level; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity
Prednisone: Administered orally, days 1-10, at a dose of 100 mg; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity
Cohort 1 Dose Escalation: participants with either refractory/relapsed (R/R) MYC-rearranged diffuse large B-cell lymphoma (DLBCL)/high-grade B-cell lymphoma (HGBCL, R/R non-germinal center B-Cell (GCB) DLBCL (no MYC rearrangement) and/or R/R peripheral T-cell lymphoma (PTCL)
|
Cohort 1/Phase 1: Arm 1 Dose Escalation Dose Level 3 Enitociclib (VIP152) 30 mg & Venetoclax 600 mg
n=2 Participants
Enitociclib (VIP152), Venetoclax and prednisone (VVIP) - VIP152 and venetoclax at escalating doses with prednisone at fixed doses to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of VIP152 and venetoclax.
Vysis LSI MYC Break Apart Rearrangement Probe Kit: MYC rearrangement fluorescence in situ hybridization (FISH) testing is performed using the Vysis LSI MYC Break Apart Rearrangement Probe (Abbott Molecular, Inc.) in the Chromosome Pathology Section, Laboratory of Pathology, Center for Cancer Research (CCR), National Cancer Institute (NCI). This kit is not Food and Drug Administration (FDA) approved. It is being used as a treatment determining in-vitro diagnostic device in this study.
Venetoclax: Administered orally, days 1-10, per specified dose level; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity
VIP152: Administered intravenously, days 2 and 9, per specified dose level; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity
Prednisone: Administered orally, days 1-10, at a dose of 100 mg; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity
Cohort 1 Dose Escalation: participants with either refractory/relapsed (R/R) MYC-rearranged diffuse large B-cell lymphoma (DLBCL)/high-grade B-cell lymphoma (HGBCL, R/R non-germinal center B-Cell (GCB) DLBCL (no MYC rearrangement) and/or R/R peripheral T-cell lymphoma (PTCL)
|
|---|---|---|---|
|
Phase 1: Event-free Survival (EFS)
|
1.48 Months
Interval 0.49 to
The confidence intervals (CI) are generated from the Brookmeyer-Crowley method, where if the estimate of a limit of a generated CI does not cross the median then it is reported as not estimable.
|
4.14 Months
Interval 2.99 to
The confidence intervals (CI) are generated from the Brookmeyer-Crowley method, where if the estimate of a limit of a generated CI does not cross the median then it is reported as not estimable.
|
1.59 Months
Interval 0.66 to
The confidence intervals (CI) are generated from the Brookmeyer-Crowley method, where if the estimate of a limit of a generated CI does not cross the median then it is reported as not estimable.
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 cycles (i.e., 72 weeks)Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Outcome measures
| Measure |
Cohort 2/Phase 2: Arm 2 Dose Expansion with Enitociclib (VIP152) & Venetoclax
n=3 Participants
No participants were enrolled in cohort 2/phase 2: Arm 2 dose expansion. Enitociclib (VIP152), Venetoclax, and prednisone (VVIP) - VIP152 and venetoclax at the recommended phase II dose (RP2D) with prednisone at fixed doses.
Vysis LSI MYC Break Apart Rearrangement Probe Kit: MYC rearrangement fluorescence in situ hybridization (FISH) testing is performed using the Vysis LSI MYC Break Apart Rearrangement Probe (Abbott Molecular, Inc.) in the Chromosome Pathology Section, Laboratory of Pathology, Center for Cancer Research (CCR), National Cancer Institute (NCI). This kit is not Food and Drug Administration (FDA) approved. It is being used as a treatment determining in-vitro diagnostic device in this study.
Venetoclax: Administered orally, days 1-10, per specified dose levelat the RP2D; every 21 days for up to 12 24 cycles, or until disease progression or unacceptable toxicity VIP152: Administered intravenously, days 2 and 9, per specified dose levelat the RP2D; every 21 days for up to 12 24 cycles, or until disease progression or unacceptable toxicity Prednisone: Administered orally, days 1-10, at a dose of 100 mg; every 21 days for up to 12 24 cycles, or until disease progression or unacceptable toxicity Participants with refractory/relapsed (R/R) MYC-rearranged diffuse large B-cell lymphoma (DLBCL)/high-grade B-cell lymphoma (HGBCL) for Phase 2 dose expansion.
|
Cohort 1/Phase 1: Arm 1 Dose Escalation Dose Level 2 Enitociclib(VIP152) 22.5 mg & Venetoclax 600 mg
n=3 Participants
Venitociclib (VIP152), venetoclax and prednisone (VVIP) - VIP152 and venetoclax at escalating doses with prednisone at fixed doses to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of VIP152 and venetoclax.
Vysis LSI MYC Break Apart Rearrangement Probe Kit: MYC rearrangement fluorescence in situ hybridization (FISH) testing is performed using the Vysis LSI MYC Break Apart Rearrangement Probe (Abbott Molecular, Inc.) in the Chromosome Pathology Section, Laboratory of Pathology, Center for Cancer Research (CCR), National Cancer Institute (NCI). This kit is not Food and Drug Administration (FDA) approved. It is being used as a treatment determining in-vitro diagnostic device in this study.
Venetoclax: Administered orally, days 1-10, per specified dose level; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity
VIP152: Administered intravenously, days 2 and 9, per specified dose level; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity
Prednisone: Administered orally, days 1-10, at a dose of 100 mg; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity
Cohort 1 Dose Escalation: participants with either refractory/relapsed (R/R) MYC-rearranged diffuse large B-cell lymphoma (DLBCL)/high-grade B-cell lymphoma (HGBCL, R/R non-germinal center B-Cell (GCB) DLBCL (no MYC rearrangement) and/or R/R peripheral T-cell lymphoma (PTCL)
|
Cohort 1/Phase 1: Arm 1 Dose Escalation Dose Level 3 Enitociclib (VIP152) 30 mg & Venetoclax 600 mg
n=2 Participants
Enitociclib (VIP152), Venetoclax and prednisone (VVIP) - VIP152 and venetoclax at escalating doses with prednisone at fixed doses to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of VIP152 and venetoclax.
Vysis LSI MYC Break Apart Rearrangement Probe Kit: MYC rearrangement fluorescence in situ hybridization (FISH) testing is performed using the Vysis LSI MYC Break Apart Rearrangement Probe (Abbott Molecular, Inc.) in the Chromosome Pathology Section, Laboratory of Pathology, Center for Cancer Research (CCR), National Cancer Institute (NCI). This kit is not Food and Drug Administration (FDA) approved. It is being used as a treatment determining in-vitro diagnostic device in this study.
Venetoclax: Administered orally, days 1-10, per specified dose level; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity
VIP152: Administered intravenously, days 2 and 9, per specified dose level; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity
Prednisone: Administered orally, days 1-10, at a dose of 100 mg; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity
Cohort 1 Dose Escalation: participants with either refractory/relapsed (R/R) MYC-rearranged diffuse large B-cell lymphoma (DLBCL)/high-grade B-cell lymphoma (HGBCL, R/R non-germinal center B-Cell (GCB) DLBCL (no MYC rearrangement) and/or R/R peripheral T-cell lymphoma (PTCL)
|
|---|---|---|---|
|
Phase 1: Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)
|
3 Participants
|
3 Participants
|
2 Participants
|
Adverse Events
Cohort 1/Phase 1:Arm 1 Dose Escalation Dose Level 1 Enitociclib (VIP152) 15 mg and Venetoclax 600 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 1 deaths
Cohort 1/Phase 1: Arm 1 Dose Escalation Dose Level 2 Enitociclib(VIP152) 22.5 mg & Venetoclax 600 mg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
Cohort 1/Phase 1:Arm 1 Dose Escalation Dose Level 3 Enitociclib (VIP152) 30 mg and Venetoclax 600 mg
Serious events: 1 serious events
Other events: 2 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Cohort 1/Phase 1:Arm 1 Dose Escalation Dose Level 1 Enitociclib (VIP152) 15 mg and Venetoclax 600 mg
n=3 participants at risk
Enitociclib (VIP152), Venetoclax and prednisone (VVIP) - VIP152 and venetoclax at escalating doses with prednisone at fixed doses to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of VIP152 and venetoclax.
Vysis LSI MYC Break Apart Rearrangement Probe Kit: MYC rearrangement fluorescence in situ hybridization (FISH) testing is performed using the Vysis LSI MYC Break Apart Rearrangement Probe (Abbott Molecular, Inc.) in the Chromosome Pathology Section, Laboratory of Pathology, Center for Cancer Research (CCR), National Cancer Institute (NCI). This kit is not Food and Drug Administration (FDA) approved. It is being used as a treatment determining in-vitro diagnostic device in this study.
Venetoclax: Administered orally, days 1-10, per specified dose level; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity
VIP152: Administered intravenously, days 2 and 9, per specified dose level; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity
Prednisone: Administered orally, days 1-10, at a dose of 100 mg; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity
Cohort 1 Dose Escalation: participants with either refractory/relapsed (R/R) MYC-rearranged diffuse large B-cell lymphoma (DLBCL)/high-grade B-cell lymphoma (HGBCL), R/R non-germinal center B-Cell (GCB) DLBCL (no MYC rearrangement) and/or R/R peripheral T-cell lymphoma (PTCL)
|
Cohort 1/Phase 1: Arm 1 Dose Escalation Dose Level 2 Enitociclib(VIP152) 22.5 mg & Venetoclax 600 mg
n=3 participants at risk
Enitociclib (VIP152), Venetoclax and prednisone (VVIP) - VIP152 and venetoclax at escalating doses with prednisone at fixed doses to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of VIP152 and venetoclax.
Vysis LSI MYC Break Apart Rearrangement Probe Kit: MYC rearrangement fluorescence in situ hybridization (FISH) testing is performed using the Vysis LSI MYC Break Apart Rearrangement Probe (Abbott Molecular, Inc.) in the Chromosome Pathology Section, Laboratory of Pathology, Center for Cancer Research (CCR), National Cancer Institute (NCI). This kit is not Food and Drug Administration (FDA) approved. It is being used as a treatment determining in-vitro diagnostic device in this study.
Venetoclax: Administered orally, days 1-10, per specified dose level; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity
VIP152: Administered intravenously, days 2 and 9, per specified dose level; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity
Prednisone: Administered orally, days 1-10, at a dose of 100 mg; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity
Cohort 1 Dose Escalation: participants with either refractory/relapsed (R/R) MYC-rearranged diffuse large B-cell lymphoma (DLBCL)/high-grade B-cell lymphoma (HGBCL, R/R non-germinal center B-Cell (GCB) DLBCL (no MYC rearrangement) and/or R/R peripheral T-cell lymphoma (PTCL)
|
Cohort 1/Phase 1:Arm 1 Dose Escalation Dose Level 3 Enitociclib (VIP152) 30 mg and Venetoclax 600 mg
n=2 participants at risk
Enitociclib (VIP152), Venetoclax and prednisone (VVIP) - VIP152 and venetoclax at escalating doses with prednisone at fixed doses to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of VIP152 and venetoclax.
Vysis LSI MYC Break Apart Rearrangement Probe Kit: MYC rearrangement fluorescence in situ hybridization (FISH) testing is performed using the Vysis LSI MYC Break Apart Rearrangement Probe (Abbott Molecular, Inc.) in the Chromosome Pathology Section, Laboratory of Pathology, Center for Cancer Research (CCR), National Cancer Institute (NCI). This kit is not Food and Drug Administration (FDA) approved. It is being used as a treatment determining in-vitro diagnostic device in this study.
Venetoclax: Administered orally, days 1-10, per specified dose level; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity
VIP152: Administered intravenously, days 2 and 9, per specified dose level; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity
Prednisone: Administered orally, days 1-10, at a dose of 100 mg; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity
Cohort 1 Dose Escalation: participants with either refractory/relapsed (R/R) MYC-rearranged diffuse large B-cell lymphoma (DLBCL)/high-grade B-cell lymphoma (HGBCL, R/R non-germinal center B-Cell (GCB) DLBCL (no MYC rearrangement) and/or R/R peripheral T-cell lymphoma (PTCL)
|
|---|---|---|---|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • All-Cause Mortality and Adverse Events was monitored/assessed 24 cycles (i.e., 72 weeks).
|
0.00%
0/3 • All-Cause Mortality and Adverse Events was monitored/assessed 24 cycles (i.e., 72 weeks).
|
50.0%
1/2 • Number of events 1 • All-Cause Mortality and Adverse Events was monitored/assessed 24 cycles (i.e., 72 weeks).
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • All-Cause Mortality and Adverse Events was monitored/assessed 24 cycles (i.e., 72 weeks).
|
0.00%
0/3 • All-Cause Mortality and Adverse Events was monitored/assessed 24 cycles (i.e., 72 weeks).
|
50.0%
1/2 • Number of events 1 • All-Cause Mortality and Adverse Events was monitored/assessed 24 cycles (i.e., 72 weeks).
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/3 • All-Cause Mortality and Adverse Events was monitored/assessed 24 cycles (i.e., 72 weeks).
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality and Adverse Events was monitored/assessed 24 cycles (i.e., 72 weeks).
|
0.00%
0/2 • All-Cause Mortality and Adverse Events was monitored/assessed 24 cycles (i.e., 72 weeks).
|
Other adverse events
| Measure |
Cohort 1/Phase 1:Arm 1 Dose Escalation Dose Level 1 Enitociclib (VIP152) 15 mg and Venetoclax 600 mg
n=3 participants at risk
Enitociclib (VIP152), Venetoclax and prednisone (VVIP) - VIP152 and venetoclax at escalating doses with prednisone at fixed doses to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of VIP152 and venetoclax.
Vysis LSI MYC Break Apart Rearrangement Probe Kit: MYC rearrangement fluorescence in situ hybridization (FISH) testing is performed using the Vysis LSI MYC Break Apart Rearrangement Probe (Abbott Molecular, Inc.) in the Chromosome Pathology Section, Laboratory of Pathology, Center for Cancer Research (CCR), National Cancer Institute (NCI). This kit is not Food and Drug Administration (FDA) approved. It is being used as a treatment determining in-vitro diagnostic device in this study.
Venetoclax: Administered orally, days 1-10, per specified dose level; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity
VIP152: Administered intravenously, days 2 and 9, per specified dose level; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity
Prednisone: Administered orally, days 1-10, at a dose of 100 mg; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity
Cohort 1 Dose Escalation: participants with either refractory/relapsed (R/R) MYC-rearranged diffuse large B-cell lymphoma (DLBCL)/high-grade B-cell lymphoma (HGBCL), R/R non-germinal center B-Cell (GCB) DLBCL (no MYC rearrangement) and/or R/R peripheral T-cell lymphoma (PTCL)
|
Cohort 1/Phase 1: Arm 1 Dose Escalation Dose Level 2 Enitociclib(VIP152) 22.5 mg & Venetoclax 600 mg
n=3 participants at risk
Enitociclib (VIP152), Venetoclax and prednisone (VVIP) - VIP152 and venetoclax at escalating doses with prednisone at fixed doses to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of VIP152 and venetoclax.
Vysis LSI MYC Break Apart Rearrangement Probe Kit: MYC rearrangement fluorescence in situ hybridization (FISH) testing is performed using the Vysis LSI MYC Break Apart Rearrangement Probe (Abbott Molecular, Inc.) in the Chromosome Pathology Section, Laboratory of Pathology, Center for Cancer Research (CCR), National Cancer Institute (NCI). This kit is not Food and Drug Administration (FDA) approved. It is being used as a treatment determining in-vitro diagnostic device in this study.
Venetoclax: Administered orally, days 1-10, per specified dose level; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity
VIP152: Administered intravenously, days 2 and 9, per specified dose level; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity
Prednisone: Administered orally, days 1-10, at a dose of 100 mg; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity
Cohort 1 Dose Escalation: participants with either refractory/relapsed (R/R) MYC-rearranged diffuse large B-cell lymphoma (DLBCL)/high-grade B-cell lymphoma (HGBCL, R/R non-germinal center B-Cell (GCB) DLBCL (no MYC rearrangement) and/or R/R peripheral T-cell lymphoma (PTCL)
|
Cohort 1/Phase 1:Arm 1 Dose Escalation Dose Level 3 Enitociclib (VIP152) 30 mg and Venetoclax 600 mg
n=2 participants at risk
Enitociclib (VIP152), Venetoclax and prednisone (VVIP) - VIP152 and venetoclax at escalating doses with prednisone at fixed doses to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of VIP152 and venetoclax.
Vysis LSI MYC Break Apart Rearrangement Probe Kit: MYC rearrangement fluorescence in situ hybridization (FISH) testing is performed using the Vysis LSI MYC Break Apart Rearrangement Probe (Abbott Molecular, Inc.) in the Chromosome Pathology Section, Laboratory of Pathology, Center for Cancer Research (CCR), National Cancer Institute (NCI). This kit is not Food and Drug Administration (FDA) approved. It is being used as a treatment determining in-vitro diagnostic device in this study.
Venetoclax: Administered orally, days 1-10, per specified dose level; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity
VIP152: Administered intravenously, days 2 and 9, per specified dose level; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity
Prednisone: Administered orally, days 1-10, at a dose of 100 mg; every 21 days for up to 12 cycles, or until disease progression or unacceptable toxicity
Cohort 1 Dose Escalation: participants with either refractory/relapsed (R/R) MYC-rearranged diffuse large B-cell lymphoma (DLBCL)/high-grade B-cell lymphoma (HGBCL, R/R non-germinal center B-Cell (GCB) DLBCL (no MYC rearrangement) and/or R/R peripheral T-cell lymphoma (PTCL)
|
|---|---|---|---|
|
Infections and infestations
Skin infection
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality and Adverse Events was monitored/assessed 24 cycles (i.e., 72 weeks).
|
0.00%
0/3 • All-Cause Mortality and Adverse Events was monitored/assessed 24 cycles (i.e., 72 weeks).
|
0.00%
0/2 • All-Cause Mortality and Adverse Events was monitored/assessed 24 cycles (i.e., 72 weeks).
|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
3/3 • Number of events 15 • All-Cause Mortality and Adverse Events was monitored/assessed 24 cycles (i.e., 72 weeks).
|
66.7%
2/3 • Number of events 13 • All-Cause Mortality and Adverse Events was monitored/assessed 24 cycles (i.e., 72 weeks).
|
100.0%
2/2 • Number of events 4 • All-Cause Mortality and Adverse Events was monitored/assessed 24 cycles (i.e., 72 weeks).
|
|
Gastrointestinal disorders
Flatulence
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality and Adverse Events was monitored/assessed 24 cycles (i.e., 72 weeks).
|
0.00%
0/3 • All-Cause Mortality and Adverse Events was monitored/assessed 24 cycles (i.e., 72 weeks).
|
0.00%
0/2 • All-Cause Mortality and Adverse Events was monitored/assessed 24 cycles (i.e., 72 weeks).
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • All-Cause Mortality and Adverse Events was monitored/assessed 24 cycles (i.e., 72 weeks).
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality and Adverse Events was monitored/assessed 24 cycles (i.e., 72 weeks).
|
0.00%
0/2 • All-Cause Mortality and Adverse Events was monitored/assessed 24 cycles (i.e., 72 weeks).
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • All-Cause Mortality and Adverse Events was monitored/assessed 24 cycles (i.e., 72 weeks).
|
0.00%
0/3 • All-Cause Mortality and Adverse Events was monitored/assessed 24 cycles (i.e., 72 weeks).
|
50.0%
1/2 • Number of events 1 • All-Cause Mortality and Adverse Events was monitored/assessed 24 cycles (i.e., 72 weeks).
|
|
Investigations
Alkaline phosphatase increased
|
66.7%
2/3 • Number of events 2 • All-Cause Mortality and Adverse Events was monitored/assessed 24 cycles (i.e., 72 weeks).
|
33.3%
1/3 • Number of events 4 • All-Cause Mortality and Adverse Events was monitored/assessed 24 cycles (i.e., 72 weeks).
|
50.0%
1/2 • Number of events 1 • All-Cause Mortality and Adverse Events was monitored/assessed 24 cycles (i.e., 72 weeks).
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • All-Cause Mortality and Adverse Events was monitored/assessed 24 cycles (i.e., 72 weeks).
|
0.00%
0/3 • All-Cause Mortality and Adverse Events was monitored/assessed 24 cycles (i.e., 72 weeks).
|
50.0%
1/2 • Number of events 1 • All-Cause Mortality and Adverse Events was monitored/assessed 24 cycles (i.e., 72 weeks).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • All-Cause Mortality and Adverse Events was monitored/assessed 24 cycles (i.e., 72 weeks).
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality and Adverse Events was monitored/assessed 24 cycles (i.e., 72 weeks).
|
0.00%
0/2 • All-Cause Mortality and Adverse Events was monitored/assessed 24 cycles (i.e., 72 weeks).
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • All-Cause Mortality and Adverse Events was monitored/assessed 24 cycles (i.e., 72 weeks).
|
0.00%
0/3 • All-Cause Mortality and Adverse Events was monitored/assessed 24 cycles (i.e., 72 weeks).
|
50.0%
1/2 • Number of events 1 • All-Cause Mortality and Adverse Events was monitored/assessed 24 cycles (i.e., 72 weeks).
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/3 • All-Cause Mortality and Adverse Events was monitored/assessed 24 cycles (i.e., 72 weeks).
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality and Adverse Events was monitored/assessed 24 cycles (i.e., 72 weeks).
|
0.00%
0/2 • All-Cause Mortality and Adverse Events was monitored/assessed 24 cycles (i.e., 72 weeks).
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • All-Cause Mortality and Adverse Events was monitored/assessed 24 cycles (i.e., 72 weeks).
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality and Adverse Events was monitored/assessed 24 cycles (i.e., 72 weeks).
|
0.00%
0/2 • All-Cause Mortality and Adverse Events was monitored/assessed 24 cycles (i.e., 72 weeks).
|
|
Investigations
Creatinine increased
|
0.00%
0/3 • All-Cause Mortality and Adverse Events was monitored/assessed 24 cycles (i.e., 72 weeks).
|
0.00%
0/3 • All-Cause Mortality and Adverse Events was monitored/assessed 24 cycles (i.e., 72 weeks).
|
50.0%
1/2 • Number of events 4 • All-Cause Mortality and Adverse Events was monitored/assessed 24 cycles (i.e., 72 weeks).
|
|
Infections and infestations
Cytomegalovirus infection reactivation
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality and Adverse Events was monitored/assessed 24 cycles (i.e., 72 weeks).
|
66.7%
2/3 • Number of events 4 • All-Cause Mortality and Adverse Events was monitored/assessed 24 cycles (i.e., 72 weeks).
|
0.00%
0/2 • All-Cause Mortality and Adverse Events was monitored/assessed 24 cycles (i.e., 72 weeks).
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality and Adverse Events was monitored/assessed 24 cycles (i.e., 72 weeks).
|
66.7%
2/3 • Number of events 2 • All-Cause Mortality and Adverse Events was monitored/assessed 24 cycles (i.e., 72 weeks).
|
0.00%
0/2 • All-Cause Mortality and Adverse Events was monitored/assessed 24 cycles (i.e., 72 weeks).
|
|
General disorders
Edema limbs
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality and Adverse Events was monitored/assessed 24 cycles (i.e., 72 weeks).
|
0.00%
0/3 • All-Cause Mortality and Adverse Events was monitored/assessed 24 cycles (i.e., 72 weeks).
|
0.00%
0/2 • All-Cause Mortality and Adverse Events was monitored/assessed 24 cycles (i.e., 72 weeks).
|
|
General disorders
Fatigue
|
66.7%
2/3 • Number of events 2 • All-Cause Mortality and Adverse Events was monitored/assessed 24 cycles (i.e., 72 weeks).
|
0.00%
0/3 • All-Cause Mortality and Adverse Events was monitored/assessed 24 cycles (i.e., 72 weeks).
|
0.00%
0/2 • All-Cause Mortality and Adverse Events was monitored/assessed 24 cycles (i.e., 72 weeks).
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
0.00%
0/3 • All-Cause Mortality and Adverse Events was monitored/assessed 24 cycles (i.e., 72 weeks).
|
0.00%
0/3 • All-Cause Mortality and Adverse Events was monitored/assessed 24 cycles (i.e., 72 weeks).
|
50.0%
1/2 • Number of events 1 • All-Cause Mortality and Adverse Events was monitored/assessed 24 cycles (i.e., 72 weeks).
|
|
Metabolism and nutrition disorders
Hypokalemia
|
100.0%
3/3 • Number of events 6 • All-Cause Mortality and Adverse Events was monitored/assessed 24 cycles (i.e., 72 weeks).
|
100.0%
3/3 • Number of events 5 • All-Cause Mortality and Adverse Events was monitored/assessed 24 cycles (i.e., 72 weeks).
|
50.0%
1/2 • Number of events 1 • All-Cause Mortality and Adverse Events was monitored/assessed 24 cycles (i.e., 72 weeks).
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
33.3%
1/3 • Number of events 3 • All-Cause Mortality and Adverse Events was monitored/assessed 24 cycles (i.e., 72 weeks).
|
100.0%
3/3 • Number of events 4 • All-Cause Mortality and Adverse Events was monitored/assessed 24 cycles (i.e., 72 weeks).
|
0.00%
0/2 • All-Cause Mortality and Adverse Events was monitored/assessed 24 cycles (i.e., 72 weeks).
|
|
Psychiatric disorders
Insomnia
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality and Adverse Events was monitored/assessed 24 cycles (i.e., 72 weeks).
|
0.00%
0/3 • All-Cause Mortality and Adverse Events was monitored/assessed 24 cycles (i.e., 72 weeks).
|
0.00%
0/2 • All-Cause Mortality and Adverse Events was monitored/assessed 24 cycles (i.e., 72 weeks).
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality and Adverse Events was monitored/assessed 24 cycles (i.e., 72 weeks).
|
0.00%
0/3 • All-Cause Mortality and Adverse Events was monitored/assessed 24 cycles (i.e., 72 weeks).
|
0.00%
0/2 • All-Cause Mortality and Adverse Events was monitored/assessed 24 cycles (i.e., 72 weeks).
|
|
Investigations
Neutrophil count decreased
|
66.7%
2/3 • Number of events 5 • All-Cause Mortality and Adverse Events was monitored/assessed 24 cycles (i.e., 72 weeks).
|
100.0%
3/3 • Number of events 13 • All-Cause Mortality and Adverse Events was monitored/assessed 24 cycles (i.e., 72 weeks).
|
50.0%
1/2 • Number of events 2 • All-Cause Mortality and Adverse Events was monitored/assessed 24 cycles (i.e., 72 weeks).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
66.7%
2/3 • Number of events 2 • All-Cause Mortality and Adverse Events was monitored/assessed 24 cycles (i.e., 72 weeks).
|
0.00%
0/3 • All-Cause Mortality and Adverse Events was monitored/assessed 24 cycles (i.e., 72 weeks).
|
0.00%
0/2 • All-Cause Mortality and Adverse Events was monitored/assessed 24 cycles (i.e., 72 weeks).
|
|
Investigations
Platelet count decreased
|
100.0%
3/3 • Number of events 7 • All-Cause Mortality and Adverse Events was monitored/assessed 24 cycles (i.e., 72 weeks).
|
66.7%
2/3 • Number of events 12 • All-Cause Mortality and Adverse Events was monitored/assessed 24 cycles (i.e., 72 weeks).
|
100.0%
2/2 • Number of events 5 • All-Cause Mortality and Adverse Events was monitored/assessed 24 cycles (i.e., 72 weeks).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality and Adverse Events was monitored/assessed 24 cycles (i.e., 72 weeks).
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality and Adverse Events was monitored/assessed 24 cycles (i.e., 72 weeks).
|
0.00%
0/2 • All-Cause Mortality and Adverse Events was monitored/assessed 24 cycles (i.e., 72 weeks).
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Tinea corporis
|
0.00%
0/3 • All-Cause Mortality and Adverse Events was monitored/assessed 24 cycles (i.e., 72 weeks).
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality and Adverse Events was monitored/assessed 24 cycles (i.e., 72 weeks).
|
0.00%
0/2 • All-Cause Mortality and Adverse Events was monitored/assessed 24 cycles (i.e., 72 weeks).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place