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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01328626 | A Phase 1 Study Evaluating the Safety and Pharmacokinetics of ABT-199 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia and Non-Hodgkin Lymphoma | PHASE1 | COMPLETED | 222 | — | — | May 23, 2011 | May 8, 2020 | Feb 23, 2022 | 10 | United States, Australia |
Protocol-defined events, which can not be attributed by the investigator to a clearly identifiable cause such as tumor progression, underlying illness, concurrent illness, or concomitant medication, will be considered a DLT. Dose limiting toxicities of tumor lysis syndrome observed during the lead-in period will be attributed to the lead-in period.
Blood and urine samples for pharmacokinetic analysis of ABT-199 will be collected at designated time points
Blood and urine samples for pharmacokinetic analysis of ABT-199 will be collected at designated time points
Blood and urine samples for pharmacokinetic analysis of ABT-199 will be collected at designated time points
| Arm | Type | Description |
|---|---|---|
| Arm A (CLL/SLL subjects) | EXPERIMENTAL | Chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) subjects |
| Arm B (NHL subjects) | EXPERIMENTAL | Non-Hodgkin lymphoma (NHL) subjects |
| Name | Type | Description |
|---|---|---|
| ABT-199 | DRUG | Arm A (Cohorts 1-8) and Arm B (Cohort 1-6): Subjects in dose escalation phase will receive 1 dose of ABT-199, followed by 6 days off drug, followed by continuous once daily dosing with ABT-199. Arm B (Cohorts 7+): Subjects in dose escalation phase will receive continuous once daily dosing with ABT-199. Arm A and Arm B: Subjects in expanded safety cohort will receive continuous once daily dosing with ABT-199. |
Inclusion Criteria: * Subject must have either: * (Arm A) relapsed or refractory CLL/SLL and require treatment in the opinion of the Investigator. Subject must have relapsed following or be refractory to standard treatments such as fludarabine based regimens (F, FC, FR, FCR) or alkylator (chlora...