Venetoclax and Ibrutinib in Treating Patients With Chronic or Small Lymphocytic Leukemia (NCT02756897) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Venetoclax and Ibrutinib in Treating Patients With Chronic or Small Lymphocytic Leukemia
United States234 participantsStarted 2016-07-07
Plain-language summary
This phase II trial studies how well venetoclax and ibrutinib work in treating patients with chronic or small lymphocytic leukemia. Venetoclax may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving venetoclax and ibrutinib may help control chronic or small lymphocytic leukemia.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients with a diagnosis of CLL/SLL:
* Cohort 1: Refractory to and/or relapsed after at least one prior therapy will be eligible
* Cohort 2: Untreated patients with high-risk features (del(17p), or mutated TP53, or del(11q), or unmutated IGHV, or \>= 65 years of age) are eligible (cohort 2) provided they have active disease requiring treatment as defined by the International Working Group for CLL (IWCLL)
* Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
* Total bilirubin =\< 1.5 x upper limit of normal (ULN) or =\< 3 x ULN for patients with Gilbert's disease (in patients \[pts\] with elevated total bilirubin due to increased indirect bilirubin, pts with direct bilirubin =\< 1.5 x ULN are eligible)
* Creatinine clearance \> 50 mL/min (calculated according to institutional standards or using Cockcroft-Gault, Modification of Diet in Renal Disease \[MDRD\], or Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] formula)
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\< 3.0 x ULN, unless clearly due to disease involvement
* Platelet count of greater than 20,000/mul, with no platelet transfusion in 2 weeks prior to registration; this criteria is waived if the thrombocytopenia is due to bone marrow involvement with the disease
* Women of childbearing potential must have a negative serum or urine beta human chorionic gonadotropin (beta-hCG) pregnancy test result within 7 days prior to the first dose of …
What they're measuring
1
Best response (complete response /complete response with incomplete recovery) of combined ibrutinib and venetoclax