A Study Evaluating the Efficacy of Venetoclax Plus Ibrutinib in Participants With T-cell Prolymph… (NCT03873493) | Clinical Trial Compass
CompletedPhase 2
A Study Evaluating the Efficacy of Venetoclax Plus Ibrutinib in Participants With T-cell Prolymphocytic Leukemia
United States, Australia, Austria14 participantsStarted 2020-01-14
Plain-language 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).
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Overall Response Rate (ORR)
Timeframe: Clinical response was assessed at Weeks 4, 8, 12, 16, and 24 for ORR assessment