Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02265731 | Study Evaluating Venetoclax in Subjects With Hematological Malignancies | PHASE1 | COMPLETED | 38 | — | — | Sep 22, 2014 | Mar 12, 2021 | Aug 2, 2021 | 14 | Japan |
Collect all adverse events at each visit
The proportion of participants with response (e.g., partial, complete response) using IWCLL (International Workshop on Chronic Lymphocytic Leukemia) criteria for CLL participants will be computed for all participants with active disease at baseline (in the opinion of the investigator).
| Arm | Type | Description |
|---|---|---|
| Arm A (Phase 1) | EXPERIMENTAL | Step-up doses of venetoclax to the designated cohort dose administered in participants with relapsed or refractory (R/R) Non-Hodgkin lymphoma (NHL) or multiple myeloma (MM) |
| Arm B (Phase 1) | EXPERIMENTAL | Step-up doses of venetoclax to the designated dose administered in participants with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) |
| Arm C (Phase 1) | EXPERIMENTAL | Step-up doses of venetoclax to the designated dose with the addition of azacitidine administered in participants with acute myeloid leukemia (AML) |
| Arm D (Phase 2) | EXPERIMENTAL | Step-up doses of venetoclax to the designated dose with the addition of rituximab in participants with R/R CLL |
| Name | Type | Description |
|---|---|---|
| azacitadine | DRUG | 75 mg/m2 by IV infusion or subcutaneous dosing |
| venetoclax | DRUG | Step-up doses of venetoclax to the designated cohort dose |
| rituximab / IDEC-C2B8 | DRUG | 375 mg/m2 on Week 6 |
Inclusion Criteria: * Participants must have histologically documented diagnosis of NHL (and exhausted options considered standard of care) as defined in the World Health Organization classification scheme and relapsed following or be refractory to standard treatments such as R-CHOP, R-CVP, or flud...