Trial Outcomes & Findings for Venetoclax, Ponatinib, and Dexamethasone in Participants With Philadelphia Chromosome or BCR-ABL Positive Relapsed or Refractory Acute Lymphoblastic Leukemia or Chronic Myelogenous Leukemia (NCT NCT03576547)
NCT ID: NCT03576547
Last Updated: 2025-05-08
Results Overview
MTD is defined as the highest dose level where a dose limiting toxicity (DLT) occurs within at most one out of six patients treated. The MTD is defined as the highest dose studied for which the observed incidence of DLT is less than 33%. Frequencies of toxicities will be tabulated according to the National Cancer Institute (NCI) Common Toxicity Criteria. Patients will be continued to be followed for one year for evidence of late toxicity.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
9 participants
Primary outcome timeframe
Up to 1 year
Results posted on
2025-05-08
Participant Flow
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
Participant milestones
| Measure |
Phase I (400 mg Ponatinib) Treatment (Ponatinib, Venetoclax, Dexamethasone, Rituximab)
The regimen consists of 4 cycles of induction/consolidation followed by up to 2 years of maintenance therapy for responding patients.
Dexamethasone: Given PO or IV
Ponatinib Hydrochloride: Given PO
Rituximab: Given IV
Venetoclax: Given PO
|
Phase I (800 mg Ponatinib) Treatment (Ponatinib, Venetoclax, Dexamethasone, Rituximab)
The regimen consists of 4 cycles of induction/consolidation followed by up to 2 years of maintenance therapy for responding patients.
Dexamethasone: Given PO or IV
Ponatinib Hydrochloride: Given PO
Rituximab: Given IV
Venetoclax: Given PO
|
Phase II Ponatinib MDT
Participants in Phase II will receive the dose that was determined to be the Maximum Tolerated Dose (MDT) found in the Phase I portion of the study. The regimen consists of 4 cycles of induction/consolidation followed by up to 2 years of maintenance therapy for responding patients.
Dexamethasone: Given PO or IV
Ponatinib Hydrochloride: Given PO
Rituximab: Given IV
Venetoclax: Given PO
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
6
|
0
|
|
Overall Study
COMPLETED
|
3
|
6
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Venetoclax, Ponatinib, and Dexamethasone in Participants With Philadelphia Chromosome or BCR-ABL Positive Relapsed or Refractory Acute Lymphoblastic Leukemia or Chronic Myelogenous Leukemia
Baseline characteristics by cohort
| Measure |
Phase I (400 mg Ponatinib) Treatment (Ponatinib, Venetoclax, Dexamethasone, Rituximab)
n=3 Participants
The regimen consists of 4 cycles of induction/consolidation followed by up to 2 years of maintenance therapy for responding patients.
Dexamethasone: Given PO or IV
Ponatinib Hydrochloride: Given PO
Rituximab: Given IV
Venetoclax: Given PO
|
Phase I (800 mg Ponatinib) Treatment (Ponatinib, Venetoclax, Dexamethasone, Rituximab)
n=6 Participants
The regimen consists of 4 cycles of induction/consolidation followed by up to 2 years of maintenance therapy for responding patients.
Dexamethasone: Given PO or IV
Ponatinib Hydrochloride: Given PO
Rituximab: Given IV
Venetoclax: Given PO
|
Phase II Ponatinib MDT
Participants in Phase II will receive the dose that was determined to be the Maximum Tolerated Dose (MDT) found in the Phase I portion of the study. The regimen consists of 4 cycles of induction/consolidation followed by up to 2 years of maintenance therapy for responding patients.
Dexamethasone: Given PO or IV
Ponatinib Hydrochloride: Given PO
Rituximab: Given IV
Venetoclax: Given PO
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
—
|
5 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
—
|
4 Participants
n=4 Participants
|
|
Age, Continuous
|
35 years
n=5 Participants
|
54 years
n=7 Participants
|
—
|
37 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
—
|
2 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
—
|
7 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
—
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
—
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
—
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
6 participants
n=7 Participants
|
—
|
9 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to 1 yearPopulation: This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
MTD is defined as the highest dose level where a dose limiting toxicity (DLT) occurs within at most one out of six patients treated. The MTD is defined as the highest dose studied for which the observed incidence of DLT is less than 33%. Frequencies of toxicities will be tabulated according to the National Cancer Institute (NCI) Common Toxicity Criteria. Patients will be continued to be followed for one year for evidence of late toxicity.
Outcome measures
| Measure |
Phase I (400 mg Ponatinib) Treatment (Ponatinib, Venetoclax, Dexamethasone, Rituximab)
n=3 Participants
The regimen consists of 4 cycles of induction/consolidation followed by up to 2 years of maintenance therapy for responding patients.
Dexamethasone: Given PO or IV
Ponatinib Hydrochloride: Given PO
Rituximab: Given IV
Venetoclax: Given PO
|
Phase I (800 mg Ponatinib) Treatment (Ponatinib, Venetoclax, Dexamethasone, Rituximab)
n=6 Participants
The regimen consists of 4 cycles of induction/consolidation followed by up to 2 years of maintenance therapy for responding patients.
Dexamethasone: Given PO or IV
Ponatinib Hydrochloride: Given PO
Rituximab: Given IV
Venetoclax: Given PO
|
Phase II Ponatinib MDT
Participants in Phase II will receive the dose that was determined to be the Maximum Tolerated Dose (MDT) found in the Phase I portion of the study. The regimen consists of 4 cycles of induction/consolidation followed by up to 2 years of maintenance therapy for responding patients.
Dexamethasone: Given PO or IV
Ponatinib Hydrochloride: Given PO
Rituximab: Given IV
Venetoclax: Given PO
|
|---|---|---|---|
|
Maximum Tolerated Dose (MTD) of Venetoclax When Given in Combination With Ponatinib and Dexamethasone (Phase I)
|
NA Milligrams
Due to insufficient number of participants, the MTD was not reached.
|
NA Milligrams
Due to insufficient number of participants, the MTD was not reached.
|
—
|
PRIMARY outcome
Timeframe: 9 weeksPopulation: This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
Overall response rate, defined as the rate or complete response (CR) + CR with incomplete count recovery (CRi). Complete Remission (CR): Normalization of the peripheral blood and bone marrow with 5% or less blasts in normocellular or hypercellular marrow with a granulocyte count of 1 x 10\^9/L or above, and platelet count of 100 x 10\^9/L. Complete resolution of all sites of extramedullary disease is required for CR. Complete remission without recovery of counts (CRi): Peripheral blood and marrow results as for CR, but with incomplete recover of counts (platelets \< 100 x 10\^9/L; neutrophils \< 1 x 10\^9/L).
Outcome measures
| Measure |
Phase I (400 mg Ponatinib) Treatment (Ponatinib, Venetoclax, Dexamethasone, Rituximab)
n=3 Participants
The regimen consists of 4 cycles of induction/consolidation followed by up to 2 years of maintenance therapy for responding patients.
Dexamethasone: Given PO or IV
Ponatinib Hydrochloride: Given PO
Rituximab: Given IV
Venetoclax: Given PO
|
Phase I (800 mg Ponatinib) Treatment (Ponatinib, Venetoclax, Dexamethasone, Rituximab)
n=6 Participants
The regimen consists of 4 cycles of induction/consolidation followed by up to 2 years of maintenance therapy for responding patients.
Dexamethasone: Given PO or IV
Ponatinib Hydrochloride: Given PO
Rituximab: Given IV
Venetoclax: Given PO
|
Phase II Ponatinib MDT
Participants in Phase II will receive the dose that was determined to be the Maximum Tolerated Dose (MDT) found in the Phase I portion of the study. The regimen consists of 4 cycles of induction/consolidation followed by up to 2 years of maintenance therapy for responding patients.
Dexamethasone: Given PO or IV
Ponatinib Hydrochloride: Given PO
Rituximab: Given IV
Venetoclax: Given PO
|
|---|---|---|---|
|
Number of Participants With a Response Complete Response (CR) + CR With Incomplete Count Recovery (CRi)
|
0 Participants
|
5 Participants
|
—
|
PRIMARY outcome
Timeframe: Monthly up to 5 years, 11 months and 7 daysPopulation: This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
Time from date of treatment start until the date of failure or death from any cause.
Outcome measures
| Measure |
Phase I (400 mg Ponatinib) Treatment (Ponatinib, Venetoclax, Dexamethasone, Rituximab)
n=3 Participants
The regimen consists of 4 cycles of induction/consolidation followed by up to 2 years of maintenance therapy for responding patients.
Dexamethasone: Given PO or IV
Ponatinib Hydrochloride: Given PO
Rituximab: Given IV
Venetoclax: Given PO
|
Phase I (800 mg Ponatinib) Treatment (Ponatinib, Venetoclax, Dexamethasone, Rituximab)
n=6 Participants
The regimen consists of 4 cycles of induction/consolidation followed by up to 2 years of maintenance therapy for responding patients.
Dexamethasone: Given PO or IV
Ponatinib Hydrochloride: Given PO
Rituximab: Given IV
Venetoclax: Given PO
|
Phase II Ponatinib MDT
Participants in Phase II will receive the dose that was determined to be the Maximum Tolerated Dose (MDT) found in the Phase I portion of the study. The regimen consists of 4 cycles of induction/consolidation followed by up to 2 years of maintenance therapy for responding patients.
Dexamethasone: Given PO or IV
Ponatinib Hydrochloride: Given PO
Rituximab: Given IV
Venetoclax: Given PO
|
|---|---|---|---|
|
Event Free Survival (EFS)
|
1.9 Months
Interval 1.7 to 2.9
|
17.6 Months
Interval 2.7 to 49.1
|
—
|
SECONDARY outcome
Timeframe: After 2 cycles of therapyPopulation: This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
The proportion of patient achieving minimal residual disease negativity (as assessed by polymerase chain reaction PCR for BCR-ABL transcripts) after 2 cycles of therapy will be estimated.
Outcome measures
| Measure |
Phase I (400 mg Ponatinib) Treatment (Ponatinib, Venetoclax, Dexamethasone, Rituximab)
n=3 Participants
The regimen consists of 4 cycles of induction/consolidation followed by up to 2 years of maintenance therapy for responding patients.
Dexamethasone: Given PO or IV
Ponatinib Hydrochloride: Given PO
Rituximab: Given IV
Venetoclax: Given PO
|
Phase I (800 mg Ponatinib) Treatment (Ponatinib, Venetoclax, Dexamethasone, Rituximab)
n=6 Participants
The regimen consists of 4 cycles of induction/consolidation followed by up to 2 years of maintenance therapy for responding patients.
Dexamethasone: Given PO or IV
Ponatinib Hydrochloride: Given PO
Rituximab: Given IV
Venetoclax: Given PO
|
Phase II Ponatinib MDT
Participants in Phase II will receive the dose that was determined to be the Maximum Tolerated Dose (MDT) found in the Phase I portion of the study. The regimen consists of 4 cycles of induction/consolidation followed by up to 2 years of maintenance therapy for responding patients.
Dexamethasone: Given PO or IV
Ponatinib Hydrochloride: Given PO
Rituximab: Given IV
Venetoclax: Given PO
|
|---|---|---|---|
|
Number of Participants Achieving Minimal Residual Disease Negativity
|
0 Participants
|
4 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to 1 yearPopulation: This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
All patients assessed for allogeneic stem cell transplant.
Outcome measures
| Measure |
Phase I (400 mg Ponatinib) Treatment (Ponatinib, Venetoclax, Dexamethasone, Rituximab)
n=3 Participants
The regimen consists of 4 cycles of induction/consolidation followed by up to 2 years of maintenance therapy for responding patients.
Dexamethasone: Given PO or IV
Ponatinib Hydrochloride: Given PO
Rituximab: Given IV
Venetoclax: Given PO
|
Phase I (800 mg Ponatinib) Treatment (Ponatinib, Venetoclax, Dexamethasone, Rituximab)
n=6 Participants
The regimen consists of 4 cycles of induction/consolidation followed by up to 2 years of maintenance therapy for responding patients.
Dexamethasone: Given PO or IV
Ponatinib Hydrochloride: Given PO
Rituximab: Given IV
Venetoclax: Given PO
|
Phase II Ponatinib MDT
Participants in Phase II will receive the dose that was determined to be the Maximum Tolerated Dose (MDT) found in the Phase I portion of the study. The regimen consists of 4 cycles of induction/consolidation followed by up to 2 years of maintenance therapy for responding patients.
Dexamethasone: Given PO or IV
Ponatinib Hydrochloride: Given PO
Rituximab: Given IV
Venetoclax: Given PO
|
|---|---|---|---|
|
Proportion of Patients Proceeding to Allogeneic Stem Cell Transplant (ASCT) a
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: From treatment initiation to death or last follow-up, up to 5 years, 11 months and 7 daysPopulation: This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
Time from date of treatment start until date of death due to any cause or last Follow-up.
Outcome measures
| Measure |
Phase I (400 mg Ponatinib) Treatment (Ponatinib, Venetoclax, Dexamethasone, Rituximab)
n=3 Participants
The regimen consists of 4 cycles of induction/consolidation followed by up to 2 years of maintenance therapy for responding patients.
Dexamethasone: Given PO or IV
Ponatinib Hydrochloride: Given PO
Rituximab: Given IV
Venetoclax: Given PO
|
Phase I (800 mg Ponatinib) Treatment (Ponatinib, Venetoclax, Dexamethasone, Rituximab)
n=6 Participants
The regimen consists of 4 cycles of induction/consolidation followed by up to 2 years of maintenance therapy for responding patients.
Dexamethasone: Given PO or IV
Ponatinib Hydrochloride: Given PO
Rituximab: Given IV
Venetoclax: Given PO
|
Phase II Ponatinib MDT
Participants in Phase II will receive the dose that was determined to be the Maximum Tolerated Dose (MDT) found in the Phase I portion of the study. The regimen consists of 4 cycles of induction/consolidation followed by up to 2 years of maintenance therapy for responding patients.
Dexamethasone: Given PO or IV
Ponatinib Hydrochloride: Given PO
Rituximab: Given IV
Venetoclax: Given PO
|
|---|---|---|---|
|
Overall Survival (OS)
|
5.4 Months
Interval 5.0 to 56.4
|
21.9 Months
Interval 14.4 to 51.6
|
—
|
SECONDARY outcome
Timeframe: Monthly up to 5 years, 11 months and 7 daysPopulation: This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
Relapse-free survival is the time from documented CR/CRi until relapse or death. Complete Remission (CR): Normalization of the peripheral blood and bone marrow with 5% or less blasts in normocellular or hypercellular marrow with a granulocyte count of 1 x 10\^9/L or above, and platelet count of 100 x 10\^9/L. Complete resolution of all sites of extramedullary disease is required for CR. Complete remission without recovery of counts (CRi): Peripheral blood and marrow results as for CR, but with incomplete recover of counts (platelets \< 100 x 10\^9/L; neutrophils \< 1 x 10\^9/L).
Outcome measures
| Measure |
Phase I (400 mg Ponatinib) Treatment (Ponatinib, Venetoclax, Dexamethasone, Rituximab)
The regimen consists of 4 cycles of induction/consolidation followed by up to 2 years of maintenance therapy for responding patients.
Dexamethasone: Given PO or IV
Ponatinib Hydrochloride: Given PO
Rituximab: Given IV
Venetoclax: Given PO
|
Phase I (800 mg Ponatinib) Treatment (Ponatinib, Venetoclax, Dexamethasone, Rituximab)
n=5 Participants
The regimen consists of 4 cycles of induction/consolidation followed by up to 2 years of maintenance therapy for responding patients.
Dexamethasone: Given PO or IV
Ponatinib Hydrochloride: Given PO
Rituximab: Given IV
Venetoclax: Given PO
|
Phase II Ponatinib MDT
Participants in Phase II will receive the dose that was determined to be the Maximum Tolerated Dose (MDT) found in the Phase I portion of the study. The regimen consists of 4 cycles of induction/consolidation followed by up to 2 years of maintenance therapy for responding patients.
Dexamethasone: Given PO or IV
Ponatinib Hydrochloride: Given PO
Rituximab: Given IV
Venetoclax: Given PO
|
|---|---|---|---|
|
Relapse-free Survival (RFS)
|
—
|
NA Months
Interval 13.3 to 48.0
Survival will be presented by median survival, which is the time point at which the cumulative survival drops below 50%. If there is no median survival (not reached), it means the cumulative survival was more than 50%.
|
—
|
Adverse Events
Phase I (400 mg Ponatinib) Treatment (Ponatinib, Venetoclax, Dexamethasone, Rituximab)
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
Phase I (800 mg Ponatinib) Treatment (Ponatinib, Venetoclax, Dexamethasone, Rituximab)
Serious events: 6 serious events
Other events: 6 other events
Deaths: 0 deaths
Phase II Ponatinib MDT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase I (400 mg Ponatinib) Treatment (Ponatinib, Venetoclax, Dexamethasone, Rituximab)
n=3 participants at risk
The regimen consists of 4 cycles of induction/consolidation followed by up to 2 years of maintenance therapy for responding patients.
Dexamethasone: Given PO or IV
Ponatinib Hydrochloride: Given PO
Rituximab: Given IV
Venetoclax: Given PO
|
Phase I (800 mg Ponatinib) Treatment (Ponatinib, Venetoclax, Dexamethasone, Rituximab)
n=6 participants at risk
The regimen consists of 4 cycles of induction/consolidation followed by up to 2 years of maintenance therapy for responding patients.
Dexamethasone: Given PO or IV
Ponatinib Hydrochloride: Given PO
Rituximab: Given IV
Venetoclax: Given PO
|
Phase II Ponatinib MDT
Participants in Phase II will receive the dose that was determined to be the Maximum Tolerated Dose (MDT) found in the Phase I portion of the study. The regimen consists of 4 cycles of induction/consolidation followed by up to 2 years of maintenance therapy for responding patients.
Dexamethasone: Given PO or IV
Ponatinib Hydrochloride: Given PO
Rituximab: Given IV
Venetoclax: Given PO
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
1/3 • Number of events 1 • Up to 5 years, 11 months and 7 days.
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
|
0.00%
0/6 • Up to 5 years, 11 months and 7 days.
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
|
—
0/0 • Up to 5 years, 11 months and 7 days.
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
0.00%
0/3 • Up to 5 years, 11 months and 7 days.
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
|
16.7%
1/6 • Number of events 1 • Up to 5 years, 11 months and 7 days.
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
|
—
0/0 • Up to 5 years, 11 months and 7 days.
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
|
|
Cardiac disorders
Chest pain - cardiac
|
0.00%
0/3 • Up to 5 years, 11 months and 7 days.
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
|
16.7%
1/6 • Number of events 1 • Up to 5 years, 11 months and 7 days.
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
|
—
0/0 • Up to 5 years, 11 months and 7 days.
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • Up to 5 years, 11 months and 7 days.
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
|
16.7%
1/6 • Number of events 3 • Up to 5 years, 11 months and 7 days.
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
|
—
0/0 • Up to 5 years, 11 months and 7 days.
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
66.7%
2/3 • Number of events 2 • Up to 5 years, 11 months and 7 days.
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
|
33.3%
2/6 • Number of events 3 • Up to 5 years, 11 months and 7 days.
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
|
—
0/0 • Up to 5 years, 11 months and 7 days.
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
|
|
General disorders
Fever
|
0.00%
0/3 • Up to 5 years, 11 months and 7 days.
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
|
16.7%
1/6 • Number of events 1 • Up to 5 years, 11 months and 7 days.
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
|
—
0/0 • Up to 5 years, 11 months and 7 days.
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
0.00%
0/3 • Up to 5 years, 11 months and 7 days.
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
|
16.7%
1/6 • Number of events 1 • Up to 5 years, 11 months and 7 days.
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
|
—
0/0 • Up to 5 years, 11 months and 7 days.
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
0.00%
0/3 • Up to 5 years, 11 months and 7 days.
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
|
16.7%
1/6 • Number of events 1 • Up to 5 years, 11 months and 7 days.
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
|
—
0/0 • Up to 5 years, 11 months and 7 days.
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • Up to 5 years, 11 months and 7 days.
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
|
16.7%
1/6 • Number of events 1 • Up to 5 years, 11 months and 7 days.
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
|
—
0/0 • Up to 5 years, 11 months and 7 days.
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
0.00%
0/3 • Up to 5 years, 11 months and 7 days.
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
|
16.7%
1/6 • Number of events 1 • Up to 5 years, 11 months and 7 days.
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
|
—
0/0 • Up to 5 years, 11 months and 7 days.
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
|
|
Infections and infestations
Lung infection
|
0.00%
0/3 • Up to 5 years, 11 months and 7 days.
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
|
16.7%
1/6 • Number of events 2 • Up to 5 years, 11 months and 7 days.
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
|
—
0/0 • Up to 5 years, 11 months and 7 days.
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/3 • Up to 5 years, 11 months and 7 days.
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
|
16.7%
1/6 • Number of events 2 • Up to 5 years, 11 months and 7 days.
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
|
—
0/0 • Up to 5 years, 11 months and 7 days.
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
0.00%
0/3 • Up to 5 years, 11 months and 7 days.
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
|
16.7%
1/6 • Number of events 1 • Up to 5 years, 11 months and 7 days.
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
|
—
0/0 • Up to 5 years, 11 months and 7 days.
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
0.00%
0/3 • Up to 5 years, 11 months and 7 days.
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
|
16.7%
1/6 • Number of events 1 • Up to 5 years, 11 months and 7 days.
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
|
—
0/0 • Up to 5 years, 11 months and 7 days.
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
|
|
General disorders
Pain
|
66.7%
2/3 • Number of events 2 • Up to 5 years, 11 months and 7 days.
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
|
0.00%
0/6 • Up to 5 years, 11 months and 7 days.
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
|
—
0/0 • Up to 5 years, 11 months and 7 days.
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/3 • Up to 5 years, 11 months and 7 days.
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
|
16.7%
1/6 • Number of events 1 • Up to 5 years, 11 months and 7 days.
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
|
—
0/0 • Up to 5 years, 11 months and 7 days.
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • Up to 5 years, 11 months and 7 days.
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
|
33.3%
2/6 • Number of events 2 • Up to 5 years, 11 months and 7 days.
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
|
—
0/0 • Up to 5 years, 11 months and 7 days.
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
|
Other adverse events
| Measure |
Phase I (400 mg Ponatinib) Treatment (Ponatinib, Venetoclax, Dexamethasone, Rituximab)
n=3 participants at risk
The regimen consists of 4 cycles of induction/consolidation followed by up to 2 years of maintenance therapy for responding patients.
Dexamethasone: Given PO or IV
Ponatinib Hydrochloride: Given PO
Rituximab: Given IV
Venetoclax: Given PO
|
Phase I (800 mg Ponatinib) Treatment (Ponatinib, Venetoclax, Dexamethasone, Rituximab)
n=6 participants at risk
The regimen consists of 4 cycles of induction/consolidation followed by up to 2 years of maintenance therapy for responding patients.
Dexamethasone: Given PO or IV
Ponatinib Hydrochloride: Given PO
Rituximab: Given IV
Venetoclax: Given PO
|
Phase II Ponatinib MDT
Participants in Phase II will receive the dose that was determined to be the Maximum Tolerated Dose (MDT) found in the Phase I portion of the study. The regimen consists of 4 cycles of induction/consolidation followed by up to 2 years of maintenance therapy for responding patients.
Dexamethasone: Given PO or IV
Ponatinib Hydrochloride: Given PO
Rituximab: Given IV
Venetoclax: Given PO
|
|---|---|---|---|
|
Investigations
Alanine aminotransferase increased
|
66.7%
2/3 • Number of events 6 • Up to 5 years, 11 months and 7 days.
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
|
16.7%
1/6 • Number of events 2 • Up to 5 years, 11 months and 7 days.
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
|
—
0/0 • Up to 5 years, 11 months and 7 days.
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
|
|
Investigations
Alkaline phosphatase increased
|
66.7%
2/3 • Number of events 6 • Up to 5 years, 11 months and 7 days.
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
|
0.00%
0/6 • Up to 5 years, 11 months and 7 days.
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
|
—
0/0 • Up to 5 years, 11 months and 7 days.
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/3 • Up to 5 years, 11 months and 7 days.
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
|
16.7%
1/6 • Number of events 1 • Up to 5 years, 11 months and 7 days.
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
|
—
0/0 • Up to 5 years, 11 months and 7 days.
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
|
|
Investigations
Aspartate aminotransferase increased
|
66.7%
2/3 • Number of events 4 • Up to 5 years, 11 months and 7 days.
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
|
0.00%
0/6 • Up to 5 years, 11 months and 7 days.
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
|
—
0/0 • Up to 5 years, 11 months and 7 days.
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
|
|
Psychiatric disorders
Depression
|
0.00%
0/3 • Up to 5 years, 11 months and 7 days.
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
|
16.7%
1/6 • Number of events 1 • Up to 5 years, 11 months and 7 days.
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
|
—
0/0 • Up to 5 years, 11 months and 7 days.
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/3 • Up to 5 years, 11 months and 7 days.
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
|
16.7%
1/6 • Number of events 1 • Up to 5 years, 11 months and 7 days.
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
|
—
0/0 • Up to 5 years, 11 months and 7 days.
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
|
|
Eye disorders
Eye infection
|
0.00%
0/3 • Up to 5 years, 11 months and 7 days.
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
|
16.7%
1/6 • Number of events 1 • Up to 5 years, 11 months and 7 days.
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
|
—
0/0 • Up to 5 years, 11 months and 7 days.
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
|
|
General disorders
Fatigue
|
0.00%
0/3 • Up to 5 years, 11 months and 7 days.
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
|
16.7%
1/6 • Number of events 1 • Up to 5 years, 11 months and 7 days.
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
|
—
0/0 • Up to 5 years, 11 months and 7 days.
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/3 • Up to 5 years, 11 months and 7 days.
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
|
16.7%
1/6 • Number of events 1 • Up to 5 years, 11 months and 7 days.
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
|
—
0/0 • Up to 5 years, 11 months and 7 days.
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.00%
0/3 • Up to 5 years, 11 months and 7 days.
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
|
16.7%
1/6 • Number of events 1 • Up to 5 years, 11 months and 7 days.
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
|
—
0/0 • Up to 5 years, 11 months and 7 days.
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • Up to 5 years, 11 months and 7 days.
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
|
66.7%
4/6 • Number of events 4 • Up to 5 years, 11 months and 7 days.
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
|
—
0/0 • Up to 5 years, 11 months and 7 days.
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
0.00%
0/3 • Up to 5 years, 11 months and 7 days.
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
|
33.3%
2/6 • Number of events 2 • Up to 5 years, 11 months and 7 days.
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
|
—
0/0 • Up to 5 years, 11 months and 7 days.
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • Up to 5 years, 11 months and 7 days.
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
|
66.7%
4/6 • Number of events 7 • Up to 5 years, 11 months and 7 days.
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
|
—
0/0 • Up to 5 years, 11 months and 7 days.
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3 • Up to 5 years, 11 months and 7 days.
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
|
16.7%
1/6 • Number of events 1 • Up to 5 years, 11 months and 7 days.
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
|
—
0/0 • Up to 5 years, 11 months and 7 days.
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • Up to 5 years, 11 months and 7 days.
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
|
50.0%
3/6 • Number of events 5 • Up to 5 years, 11 months and 7 days.
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
|
—
0/0 • Up to 5 years, 11 months and 7 days.
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • Up to 5 years, 11 months and 7 days.
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
|
16.7%
1/6 • Number of events 1 • Up to 5 years, 11 months and 7 days.
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
|
—
0/0 • Up to 5 years, 11 months and 7 days.
This study did not move on from the Phase I portion of this trial. There was no MTD reached and zero participants were registered on Phase II of this study.
|
Additional Information
Farhad Ravandi-Kashani, MD./Professor
The University of Texas MD Anderson Cancer Center
Phone: 713-745-0394
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place