Trial Outcomes & Findings for Venetoclax, Carmustine, Etoposide, Cytarabine, and Melphalan Before Stem Cell Transplant in Treating Participants With Relapsed or Refractory Non-Hodgkin Lymphoma (NCT NCT03583424)
NCT ID: NCT03583424
Last Updated: 2025-05-14
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
19 participants
Primary outcome timeframe
Up to 2 years
Results posted on
2025-05-14
Participant Flow
For this study, dose level 3 was determined to be the maximum tolerated dose (MTD). Therefore, 10 patients who were accrued for the expansion phase were treated at the MTD. Combining with 3 patients treated at dose level 3 in the escalation phase, all 13 patients were treated at the same dose level. Therefore, they were grouped together for the results reporting.
Participant milestones
| Measure |
Cohort A (Venetoclax 400 mg and BEAM Conditioning Followed by Autologous Stem Cell Transplantation
Participants receive Venetoclax PO QD on days -10 to -1, carmustine IV on day -6, etoposide IV BID on days -5 to -2, cytarabine IV BID on days -5 to -2, and melphalan IV on day -1. Participants then undergo hematopoietic cell transplantation on day 0.
Carmustine: Given IV
Cytarabine: Given IV
Etoposide: Given IV
Hematopoietic Cell Transplantation: Undergo hematopoietic cell transplantation
Melphalan: Given IV
Venetoclax: Given PO
|
Cohort B (Venetoclax 800mg and BEAM Conditioning Followed by Autologous Stem Cell Transplantation)
Participants receive Venetoclax PO QD on days -10 to -1, carmustine IV on day -6, etoposide IV BID on days -5 to -2, cytarabine IV BID on days -5 to -2, and melphalan IV on day -1. Participants then undergo hematopoietic cell transplantation on day 0.
Carmustine: Given IV
Cytarabine: Given IV
Etoposide: Given IV
Hematopoietic Cell Transplantation: Undergo hematopoietic cell transplantation
Melphalan: Given IV
Venetoclax: Given PO
|
Cohort C (Venetoclax 1200mg and BEAM Conditioning Followed by Autologous Stem Cell Transplantation)
Participants receive Venetoclax PO QD on days -10 to -1, carmustine IV on day -6, etoposide IV BID on days -5 to -2, cytarabine IV BID on days -5 to -2, and melphalan IV on day -1. Participants then undergo hematopoietic cell transplantation on day 0.
Carmustine: Given IV
Cytarabine: Given IV
Etoposide: Given IV
Hematopoietic Cell Transplantation: Undergo hematopoietic cell transplantation
Melphalan: Given IV
Venetoclax: Given PO
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
13
|
|
Overall Study
COMPLETED
|
3
|
3
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Venetoclax, Carmustine, Etoposide, Cytarabine, and Melphalan Before Stem Cell Transplant in Treating Participants With Relapsed or Refractory Non-Hodgkin Lymphoma
Baseline characteristics by cohort
| Measure |
Cohort A (Venetoclax 400mg and BEAM Conditioning Followed by Autologous Stem Cell Transplantation)
n=3 Participants
Participants receive Venetoclax PO QD on days -10 to -1, carmustine IV on day -6, etoposide IV BID on days -5 to -2, cytarabine IV BID on days -5 to -2, and melphalan IV on day -1. Participants then undergo hematopoietic cell transplantation on day 0.
Carmustine: Given IV
Cytarabine: Given IV
Etoposide: Given IV
Hematopoietic Cell Transplantation: Undergo hematopoietic cell transplantation
Melphalan: Given IV
Venetoclax: Given PO
|
Cohort B (Venetoclax 800mg and BEAM Conditioning Followed by Autologous Stem Cell Transplantation)
n=3 Participants
Participants receive Venetoclax PO QD on days -10 to -1, carmustine IV on day -6, etoposide IV BID on days -5 to -2, cytarabine IV BID on days -5 to -2, and melphalan IV on day -1. Participants then undergo hematopoietic cell transplantation on day 0.
Carmustine: Given IV
Cytarabine: Given IV
Etoposide: Given IV
Hematopoietic Cell Transplantation: Undergo hematopoietic cell transplantation
Melphalan: Given IV
Venetoclax: Given PO
|
Cohort C (Venetoclax 1200mg and BEAM Conditioning Followed by Autologous Stem Cell Transplantation)
n=13 Participants
Participants receive Venetoclax PO QD on days -10 to -1, carmustine IV on day -6, etoposide IV BID on days -5 to -2, cytarabine IV BID on days -5 to -2, and melphalan IV on day -1. Participants then undergo hematopoietic cell transplantation on day 0.
Carmustine: Given IV
Cytarabine: Given IV
Etoposide: Given IV
Hematopoietic Cell Transplantation: Undergo hematopoietic cell transplantation
Melphalan: Given IV
Venetoclax: Given PO
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
64 years
n=93 Participants
|
52 years
n=4 Participants
|
61 years
n=27 Participants
|
61 years
n=483 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
15 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
19 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
18 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=93 Participants
|
3 participants
n=4 Participants
|
13 participants
n=27 Participants
|
19 participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Up to 2 yearsOutcome measures
| Measure |
Treatment (Venetoclax, BEAM)
n=10 Participants
Participants receive venetoclax PO QD on days -10 to -1, carmustine IV on day -6, etoposide IV BID on days -5 to -2, cytarabine IV BID on days -5 to -2, and melphalan IV on day -1. Participants then undergo hematopoietic cell transplantation on day 0.
Carmustine: Given IV
Cytarabine: Given IV
Etoposide: Given IV
Hematopoietic Cell Transplantation: Undergo hematopoietic cell transplantation
Melphalan: Given IV
Venetoclax: Given PO
|
Cohort B (Venetoclax 800 mg and BEAM Conditioning Followed by Autologous Stem Cell Transplantation
Participants receive venetoclax PO QD on days -10 to -1, carmustine IV on day -6, etoposide IV BID on days -5 to -2, cytarabine IV BID on days -5 to -2, and melphalan IV on day -1. Participants then undergo hematopoietic cell transplantation on day 0.
Carmustine: Given IV
Cytarabine: Given IV
Etoposide: Given IV
Hematopoietic Cell Transplantation: Undergo hematopoietic cell transplantation
Melphalan: Given IV
Venetoclax: Given PO
|
Cohort C (Venetoclax 1200 mg and BEAM Conditioning Followed by Autologous Stem Cell Transplantation
Participants receive venetoclax PO QD on days -10 to -1, carmustine IV on day -6, etoposide IV BID on days -5 to -2, cytarabine IV BID on days -5 to -2, and melphalan IV on day -1. Participants then undergo hematopoietic cell transplantation on day 0.
Carmustine: Given IV
Cytarabine: Given IV
Etoposide: Given IV
Hematopoietic Cell Transplantation: Undergo hematopoietic cell transplantation
Melphalan: Given IV
Venetoclax: Given PO
|
|---|---|---|---|
|
Maximum Tolerated Dose of Venetoclax Defined to be the Dose Cohort Below Which 3 Out of 6 Patients Experience Dose Limiting Toxicities or the Highest Dose Cohort of 1200 mg, if 2 Dose Limiting Toxicities Are Not Observed at Any Dose Cohort
|
1200 mg
|
—
|
—
|
PRIMARY outcome
Timeframe: At day 100Will be estimated as the proportions of patients who achieve a complete response or partial response divided by the number of evaluable patients. Each will be reported with their associated 95% confidence interval.
Outcome measures
| Measure |
Treatment (Venetoclax, BEAM)
n=3 Participants
Participants receive venetoclax PO QD on days -10 to -1, carmustine IV on day -6, etoposide IV BID on days -5 to -2, cytarabine IV BID on days -5 to -2, and melphalan IV on day -1. Participants then undergo hematopoietic cell transplantation on day 0.
Carmustine: Given IV
Cytarabine: Given IV
Etoposide: Given IV
Hematopoietic Cell Transplantation: Undergo hematopoietic cell transplantation
Melphalan: Given IV
Venetoclax: Given PO
|
Cohort B (Venetoclax 800 mg and BEAM Conditioning Followed by Autologous Stem Cell Transplantation
n=3 Participants
Participants receive venetoclax PO QD on days -10 to -1, carmustine IV on day -6, etoposide IV BID on days -5 to -2, cytarabine IV BID on days -5 to -2, and melphalan IV on day -1. Participants then undergo hematopoietic cell transplantation on day 0.
Carmustine: Given IV
Cytarabine: Given IV
Etoposide: Given IV
Hematopoietic Cell Transplantation: Undergo hematopoietic cell transplantation
Melphalan: Given IV
Venetoclax: Given PO
|
Cohort C (Venetoclax 1200 mg and BEAM Conditioning Followed by Autologous Stem Cell Transplantation
n=13 Participants
Participants receive venetoclax PO QD on days -10 to -1, carmustine IV on day -6, etoposide IV BID on days -5 to -2, cytarabine IV BID on days -5 to -2, and melphalan IV on day -1. Participants then undergo hematopoietic cell transplantation on day 0.
Carmustine: Given IV
Cytarabine: Given IV
Etoposide: Given IV
Hematopoietic Cell Transplantation: Undergo hematopoietic cell transplantation
Melphalan: Given IV
Venetoclax: Given PO
|
|---|---|---|---|
|
Overall Response Rate
|
33 percentage of participants
|
67 percentage of participants
|
69 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsEstimated using Kaplan-Meier method.
Outcome measures
| Measure |
Treatment (Venetoclax, BEAM)
n=3 Participants
Participants receive venetoclax PO QD on days -10 to -1, carmustine IV on day -6, etoposide IV BID on days -5 to -2, cytarabine IV BID on days -5 to -2, and melphalan IV on day -1. Participants then undergo hematopoietic cell transplantation on day 0.
Carmustine: Given IV
Cytarabine: Given IV
Etoposide: Given IV
Hematopoietic Cell Transplantation: Undergo hematopoietic cell transplantation
Melphalan: Given IV
Venetoclax: Given PO
|
Cohort B (Venetoclax 800 mg and BEAM Conditioning Followed by Autologous Stem Cell Transplantation
n=3 Participants
Participants receive venetoclax PO QD on days -10 to -1, carmustine IV on day -6, etoposide IV BID on days -5 to -2, cytarabine IV BID on days -5 to -2, and melphalan IV on day -1. Participants then undergo hematopoietic cell transplantation on day 0.
Carmustine: Given IV
Cytarabine: Given IV
Etoposide: Given IV
Hematopoietic Cell Transplantation: Undergo hematopoietic cell transplantation
Melphalan: Given IV
Venetoclax: Given PO
|
Cohort C (Venetoclax 1200 mg and BEAM Conditioning Followed by Autologous Stem Cell Transplantation
n=13 Participants
Participants receive venetoclax PO QD on days -10 to -1, carmustine IV on day -6, etoposide IV BID on days -5 to -2, cytarabine IV BID on days -5 to -2, and melphalan IV on day -1. Participants then undergo hematopoietic cell transplantation on day 0.
Carmustine: Given IV
Cytarabine: Given IV
Etoposide: Given IV
Hematopoietic Cell Transplantation: Undergo hematopoietic cell transplantation
Melphalan: Given IV
Venetoclax: Given PO
|
|---|---|---|---|
|
Number of Participants With Progression of Disease
|
3 Participants
|
0 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsEstimated using Kaplan-Meier method.
Outcome measures
| Measure |
Treatment (Venetoclax, BEAM)
n=3 Participants
Participants receive venetoclax PO QD on days -10 to -1, carmustine IV on day -6, etoposide IV BID on days -5 to -2, cytarabine IV BID on days -5 to -2, and melphalan IV on day -1. Participants then undergo hematopoietic cell transplantation on day 0.
Carmustine: Given IV
Cytarabine: Given IV
Etoposide: Given IV
Hematopoietic Cell Transplantation: Undergo hematopoietic cell transplantation
Melphalan: Given IV
Venetoclax: Given PO
|
Cohort B (Venetoclax 800 mg and BEAM Conditioning Followed by Autologous Stem Cell Transplantation
n=3 Participants
Participants receive venetoclax PO QD on days -10 to -1, carmustine IV on day -6, etoposide IV BID on days -5 to -2, cytarabine IV BID on days -5 to -2, and melphalan IV on day -1. Participants then undergo hematopoietic cell transplantation on day 0.
Carmustine: Given IV
Cytarabine: Given IV
Etoposide: Given IV
Hematopoietic Cell Transplantation: Undergo hematopoietic cell transplantation
Melphalan: Given IV
Venetoclax: Given PO
|
Cohort C (Venetoclax 1200 mg and BEAM Conditioning Followed by Autologous Stem Cell Transplantation
n=13 Participants
Participants receive venetoclax PO QD on days -10 to -1, carmustine IV on day -6, etoposide IV BID on days -5 to -2, cytarabine IV BID on days -5 to -2, and melphalan IV on day -1. Participants then undergo hematopoietic cell transplantation on day 0.
Carmustine: Given IV
Cytarabine: Given IV
Etoposide: Given IV
Hematopoietic Cell Transplantation: Undergo hematopoietic cell transplantation
Melphalan: Given IV
Venetoclax: Given PO
|
|---|---|---|---|
|
Number of Participants Free From Relapse
|
0 Participants
|
3 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsEstimated using Kaplan-Meier method.
Outcome measures
| Measure |
Treatment (Venetoclax, BEAM)
n=3 Participants
Participants receive venetoclax PO QD on days -10 to -1, carmustine IV on day -6, etoposide IV BID on days -5 to -2, cytarabine IV BID on days -5 to -2, and melphalan IV on day -1. Participants then undergo hematopoietic cell transplantation on day 0.
Carmustine: Given IV
Cytarabine: Given IV
Etoposide: Given IV
Hematopoietic Cell Transplantation: Undergo hematopoietic cell transplantation
Melphalan: Given IV
Venetoclax: Given PO
|
Cohort B (Venetoclax 800 mg and BEAM Conditioning Followed by Autologous Stem Cell Transplantation
n=3 Participants
Participants receive venetoclax PO QD on days -10 to -1, carmustine IV on day -6, etoposide IV BID on days -5 to -2, cytarabine IV BID on days -5 to -2, and melphalan IV on day -1. Participants then undergo hematopoietic cell transplantation on day 0.
Carmustine: Given IV
Cytarabine: Given IV
Etoposide: Given IV
Hematopoietic Cell Transplantation: Undergo hematopoietic cell transplantation
Melphalan: Given IV
Venetoclax: Given PO
|
Cohort C (Venetoclax 1200 mg and BEAM Conditioning Followed by Autologous Stem Cell Transplantation
n=13 Participants
Participants receive venetoclax PO QD on days -10 to -1, carmustine IV on day -6, etoposide IV BID on days -5 to -2, cytarabine IV BID on days -5 to -2, and melphalan IV on day -1. Participants then undergo hematopoietic cell transplantation on day 0.
Carmustine: Given IV
Cytarabine: Given IV
Etoposide: Given IV
Hematopoietic Cell Transplantation: Undergo hematopoietic cell transplantation
Melphalan: Given IV
Venetoclax: Given PO
|
|---|---|---|---|
|
Overall Survival
|
NA Months
Median Overall Survival not reached
|
NA Months
Median Overall Survival not reached
|
NA Months
Median Overall Survival not reached
|
Adverse Events
Cohort A (Venetoclax 400mg and BEAM Conditioning Followed by Autologous Stem Cell Transplantation
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort B (Venetoclax 800mg and BEAM Conditioning Followed by Autologous Stem Cell Transplantation
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort C (Venetoclax 1200mg and BEAM Conditioning Followed by Autologous Stem Cell Transplantation
Serious events: 4 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort A (Venetoclax 400mg and BEAM Conditioning Followed by Autologous Stem Cell Transplantation
n=3 participants at risk
Participants receive Venetoclax PO QD on days -10 to -1, carmustine IV on day -6, etoposide IV BID on days -5 to -2, cytarabine IV BID on days -5 to -2, and melphalan IV on day -1. Participants then undergo hematopoietic cell transplantation on day 0.
Carmustine: Given IV
Cytarabine: Given IV
Etoposide: Given IV
Hematopoietic Cell Transplantation: Undergo hematopoietic cell transplantation
Melphalan: Given IV
Venetoclax: Given PO
|
Cohort B (Venetoclax 800mg and BEAM Conditioning Followed by Autologous Stem Cell Transplantation
n=3 participants at risk
Participants receive Venetoclax PO QD on days -10 to -1, carmustine IV on day -6, etoposide IV BID on days -5 to -2, cytarabine IV BID on days -5 to -2, and melphalan IV on day -1. Participants then undergo hematopoietic cell transplantation on day 0.
Carmustine: Given IV
Cytarabine: Given IV
Etoposide: Given IV
Hematopoietic Cell Transplantation: Undergo hematopoietic cell transplantation
Melphalan: Given IV
Venetoclax: Given PO
|
Cohort C (Venetoclax 1200mg and BEAM Conditioning Followed by Autologous Stem Cell Transplantation
n=13 participants at risk
Participants receive Venetoclax PO QD on days -10 to -1, carmustine IV on day -6, etoposide IV BID on days -5 to -2, cytarabine IV BID on days -5 to -2, and melphalan IV on day -1. Participants then undergo hematopoietic cell transplantation on day 0.
Carmustine: Given IV
Cytarabine: Given IV
Etoposide: Given IV
Hematopoietic Cell Transplantation: Undergo hematopoietic cell transplantation
Melphalan: Given IV
Venetoclax: Given PO
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/3 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
0.00%
0/3 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
15.4%
2/13 • Number of events 2 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/3 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
0.00%
0/3 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
7.7%
1/13 • Number of events 1 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/3 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
33.3%
1/3 • Number of events 1 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
30.8%
4/13 • Number of events 4 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
0.00%
0/3 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
23.1%
3/13 • Number of events 3 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
0.00%
0/3 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
15.4%
2/13 • Number of events 2 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
33.3%
1/3 • Number of events 1 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
0.00%
0/3 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
0.00%
0/13 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
Other adverse events
| Measure |
Cohort A (Venetoclax 400mg and BEAM Conditioning Followed by Autologous Stem Cell Transplantation
n=3 participants at risk
Participants receive Venetoclax PO QD on days -10 to -1, carmustine IV on day -6, etoposide IV BID on days -5 to -2, cytarabine IV BID on days -5 to -2, and melphalan IV on day -1. Participants then undergo hematopoietic cell transplantation on day 0.
Carmustine: Given IV
Cytarabine: Given IV
Etoposide: Given IV
Hematopoietic Cell Transplantation: Undergo hematopoietic cell transplantation
Melphalan: Given IV
Venetoclax: Given PO
|
Cohort B (Venetoclax 800mg and BEAM Conditioning Followed by Autologous Stem Cell Transplantation
n=3 participants at risk
Participants receive Venetoclax PO QD on days -10 to -1, carmustine IV on day -6, etoposide IV BID on days -5 to -2, cytarabine IV BID on days -5 to -2, and melphalan IV on day -1. Participants then undergo hematopoietic cell transplantation on day 0.
Carmustine: Given IV
Cytarabine: Given IV
Etoposide: Given IV
Hematopoietic Cell Transplantation: Undergo hematopoietic cell transplantation
Melphalan: Given IV
Venetoclax: Given PO
|
Cohort C (Venetoclax 1200mg and BEAM Conditioning Followed by Autologous Stem Cell Transplantation
n=13 participants at risk
Participants receive Venetoclax PO QD on days -10 to -1, carmustine IV on day -6, etoposide IV BID on days -5 to -2, cytarabine IV BID on days -5 to -2, and melphalan IV on day -1. Participants then undergo hematopoietic cell transplantation on day 0.
Carmustine: Given IV
Cytarabine: Given IV
Etoposide: Given IV
Hematopoietic Cell Transplantation: Undergo hematopoietic cell transplantation
Melphalan: Given IV
Venetoclax: Given PO
|
|---|---|---|---|
|
Investigations
Activated Partial Thromboplastin Time Prolonged
|
0.00%
0/3 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
0.00%
0/3 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
15.4%
2/13 • Number of events 2 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
1/3 • Number of events 1 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
0.00%
0/3 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
0.00%
0/13 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
|
Investigations
Alkaline phosphatase increased
|
33.3%
1/3 • Number of events 1 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
0.00%
0/3 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
0.00%
0/13 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
1/3 • Number of events 1 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
33.3%
1/3 • Number of events 1 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
7.7%
1/13 • Number of events 1 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
|
Cardiac disorders
Atrial fibrillation
|
33.3%
1/3 • Number of events 1 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
0.00%
0/3 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
0.00%
0/13 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
0.00%
0/3 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
7.7%
1/13 • Number of events 1 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/3 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
0.00%
0/3 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
15.4%
2/13 • Number of events 2 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
0.00%
0/3 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
7.7%
1/13 • Number of events 1 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
|
General disorders
Fatigue
|
0.00%
0/3 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
0.00%
0/3 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
7.7%
1/13 • Number of events 1 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
|
Gastrointestinal disorders
Gastrointestinal disorder, GI
|
33.3%
1/3 • Number of events 1 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
0.00%
0/3 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
0.00%
0/13 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
66.7%
2/3 • Number of events 2 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
33.3%
1/3 • Number of events 1 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
15.4%
2/13 • Number of events 2 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/3 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
0.00%
0/3 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
7.7%
1/13 • Number of events 1 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/3 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
0.00%
0/3 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
7.7%
1/13 • Number of events 1 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/3 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
0.00%
0/3 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
23.1%
3/13 • Number of events 3 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/3 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
0.00%
0/3 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
30.8%
4/13 • Number of events 4 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/3 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
0.00%
0/3 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
7.7%
1/13 • Number of events 1 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
|
Investigations
INR increased
|
0.00%
0/3 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
0.00%
0/3 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
15.4%
2/13 • Number of events 2 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
|
Infections and infestations
Infection
|
0.00%
0/3 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
0.00%
0/3 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
7.7%
1/13 • Number of events 1 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
0.00%
0/3 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
7.7%
1/13 • Number of events 1 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
|
Infections and infestations
Lung infection
|
33.3%
1/3 • Number of events 1 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
0.00%
0/3 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
0.00%
0/13 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
|
Investigations
Lymphocyte count decreased
|
33.3%
1/3 • Number of events 1 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
0.00%
0/3 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
0.00%
0/13 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
0.00%
0/3 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
7.7%
1/13 • Number of events 1 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Number of events 1 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
0.00%
0/3 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
0.00%
0/13 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/3 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
33.3%
1/3 • Number of events 1 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
0.00%
0/13 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
|
Skin and subcutaneous tissue disorders
Pain (at line site)
|
0.00%
0/3 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
33.3%
1/3 • Number of events 1 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
0.00%
0/13 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
0.00%
0/3 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
7.7%
1/13 • Number of events 1 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
|
Investigations
Platelet count decreased
|
66.7%
2/3 • Number of events 2 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
33.3%
1/3 • Number of events 1 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
7.7%
1/13 • Number of events 1 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
0.00%
0/3 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
7.7%
1/13 • Number of events 1 • The National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting for up to 2 years
|
Additional Information
Dr. Kami Maddocks
The Ohio State University Comprehensive Cancer Center
Phone: 614-293-9165
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place