A Study Evaluating the Efficacy of Venetoclax Plus Ibrutinib in Subjects With T-cell Prolymphocytic Leukemia

Overview

About this study

The purpose of this study is to evaluate the safety and effectiveness 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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.
  • 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.

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.
  • Previously treated with a B-cell lymphoma (BCL)-2 inhibitor.
  • Received a prohibited therapy within the specified time frame as described in the protocol.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Wei Ding, M.B.B.S., Ph.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

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More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions