Phase 2
Completed N=14
A Study Evaluating the Efficacy of Venetoclax Plus Ibrutinib in Participants With T-cell Prolymphocytic Leukemia
Source: ClinicalTrials.gov NCT03873493 ↗Enrolled (actual)
14
Serious AEs
57.1%
Results posted
Dec 2022
Primary outcomePrimary: Overall Response Rate (ORR) — 7.1 percentage of participants
Summary
The main objective of this study is to evaluate the efficacy of the combination of venetoclax plus ibrutinib for treating adults with T-cell prolymphocytic leukemia (T-PLL).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Response Rate (ORR) |
7.1 | — |
| SECONDARY Progression-Free Survival (PFS) |
2.7 | — |
| SECONDARY Duration of Response (DOR) |
4.6 | — |
| SECONDARY Time to Progression (TTP) |
2.7 | — |
| SECONDARY Event-free Survival (EFS) |
2.6 | — |
| SECONDARY Disease Control Rate (DCR) |
28.6 | — |
| SECONDARY Overall Survival (OS) |
7.3 | — |
| SECONDARY Number of Eligible Participants Reaching Autologous or Allogeneic Transplantation |
— | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAE) |
14; 11; 8; 11; 9; 2 | — |
Eligibility Criteria
Inclusion Criteria
- Adequate liver, kidney and hematology function per laboratory values as described in the protocol.
- Diagnosis of T-cell prolymphocytic leukemia (T-PLL) that requires treatment.
- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2.
- Received prior alemtuzumab (unless unsuitable or unavailable).
- Has no malignancies other than T-PLL that:
- currently require systemic therapies;
- were not previously treated with curative intention (unless the malignant disease is in a stable remission due to the discretion of the treating physician); or
- developed signs of progression after curative treatment.
Exclusion Criteria
- History of or current decompensated cirrhosis including Child-Pugh class B or C, ascites, hepatic encephalopathy, or variceal bleeding.
- Has human T-cell lymphotropic virus, type 1.
- Prior allogeneic stem cell transplant within 6 months of study drug administration and requirement for graft versus host therapy.
- Has an uncontrolled or active infection including severe acute respiratory syndrome- coronavirus-2 (SARS-COV-2).
- Previously treated with a B-cell lymphoma (BCL)-2 inhibitor.
- Received a prohibited therapy within the specified time frame as described in the protocol.
Data sourced from ClinicalTrials.gov (NCT03873493). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.