Clinical trial · Interventional
A Study Evaluating the Efficacy of Venetoclax Plus Ibrutinib in Participants With T-cell Prolymphocytic Leukemia
A Prospective, Open-Label, Single-Arm, Phase 2, Multicenter Study Evaluating the Efficacy of Venetoclax Plus Ibrutinib in Subjects With T-Cell Prolymphocytic Leukemia
NCT03873493CI-TRIAL-00062746completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| T-cell Prolymphocytic Leukemia (T-PLL) | T-Cell Prolymphocytic Leukemia | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ibrutinib | Drug | Ibrutinib | ALIAS |
| Venetoclax | Drug | Venetoclax | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Venetoclax + Ibrutinib
- description
- Participants received 400 mg venetoclax orally once a day after a 5-day ramp-up and 420 mg ibrutinib orally once a day for up to 2 years or until progressive disease, intolerability, or they became eligible for stem cell transplantation after achieving complete remission.
- interventionNames
- Drug: Venetoclax
- Drug: Ibrutinib
Primary outcomes (1)
- measure
- Overall Response Rate (ORR)
- timeFrame
- Clinical response was assessed at Weeks 4, 8, 12, 16, and 24 for ORR assessment
- description
- ORR is defined as the percentage of participants achieving complete remission (CR), CR with incomplete bone marrow recovery (CRi), or partial remission (PR) as their best response per investigator assessment based on the T-PLL consensus criteria 2019. CR: All of the following response criteria must be met: Group A: * all lymph nodes \< 1 cm; * spleen \< 13 cm; * no constitutional symptoms; * circulating lymphocyte count \< 4 × 10\^9/L; * bone marrow T-PLL cells \< 5% of mononuclear cells; * no other specific site involvement Group B: * platelets ≥ 100 × 10\^9 /L; * hemoglobin ≥ 11.0 g/dL; * neutrophils ≥ 1.5 × 10\^9 /L. CRi: All of the CR response criteria in Group A met; at least 1 parameter in Group B not achieved, unrelated to T-PLL, but related to drug toxicity. PR: At least 2 of the parameters in Group A and 1 parameter in Group B need to improve if previously abnormal. If only 1 parameter of both Groups A and B is abnormal prior to therapy, only 1 parameter needs to improve.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.