Status:
COMPLETED
A Study Evaluating the Efficacy of Venetoclax Plus Ibrutinib in Participants With T-cell Prolymphocytic Leukemia
Lead Sponsor:
AbbVie
Conditions:
Leukemia
T-cell Prolymphocytic Leukemia (T-PLL)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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).
Detailed Description
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-spe...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 4 2021
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT03873493
Start Date
January 14 2020
End Date
November 4 2021
Last Update
December 19 2022
Active Locations (15)
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1
Dana-Farber Cancer Institute /ID# 207728
Boston, Massachusetts, United States, 02215
2
Mayo Clinic - Rochester /ID# 207692
Rochester, Minnesota, United States, 55905-0001
3
University of Texas MD Anderson Cancer Center /ID# 207746
Houston, Texas, United States, 77030
4
Peter MacCallum Cancer Ctr /ID# 209554
Melbourne, Victoria, Australia, 3000