A Study Evaluating the Efficacy of Venetoclax Plus Ibrutinib in Subjects With T-cell Prolymphocytic Leukemia
Trial Status: Active
A study to evaluate the safety and efficacy of venetoclax plus ibrutinib for participants with T-cell Prolymphocytic Leukemia (T-PLL) and follows a 2-stage design as follows: Stage 1: Enroll up to 14 participants and move to Stage 2 if 4 or more subjects meet protocol-specified response criteria. Response assessment will be performed on a continued basis until all 14 participants have enrolled into Stage 1 and have completed the Week 24 disease assessment. Stage 2: Enroll up to an additional 23 participants with previously untreated or relapsed or refractory T-PLL.
- 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.
- Negative for human T-cell lymphotropic virus, type 1.
- 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.
- 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.
- Previously treated with a B-cell lymphoma (BCL)-2 inhibitor.
- Received a prohibited therapy within the specified time frame as described in the protocol.
Brigham and Women's Hospital
Dana-Farber Cancer Institute
Mayo Clinic in Rochester
M D Anderson Cancer Center
Trial Phase Phase II
Trial Type Treatment
- Primary ID M18-803
- Secondary IDs NCI-2020-03907, 2018-002179-17
- Clinicaltrials.gov ID NCT03873493