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

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).

This study is planned as an adaptive 2-stage design as follows:

Stage 1: Enroll 14 participants with relapsed or refractory (R/R) T-PLL and move to Stage 2 if 4 or more participants 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.

The study was stopped after Stage 1. Stage 2 was not conducted.

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.