OncoMatch/Clinical Trials/NCT04169737
Acalabrutinib and Venetoclax With or Without Early Obinutuzumab for the Treatment of High Risk, Recurrent, or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Is NCT04169737 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Obinutuzumab and Acalabrutinib for recurrent chronic lymphocytic leukemia.
Treatment: Acalabrutinib · Obinutuzumab · Venetoclax — This phase II trial studies how well acalabrutinib and venetoclax with or without early obinutuzumab work for the treatment of chronic lymphocytic leukemia or small lymphocytic lymphoma that is high risk, has come back (recurrent), or does not respond to treatment (refractory). Acalabrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Venetoclax may stop the growth cancer cells by blocking BCL-2 protein needed for cell growth. Immunotherapy with monoclonal antibodies, such as obinutuzumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving acalabrutinib and venetoclax together with early obinutuzumab may improve clinical outcomes and control the disease.
Check if I qualifyExtracted eligibility criteria
Cancer type
Chronic Lymphocytic Leukemia
Non-Hodgkin Lymphoma
Biomarker criteria
Allowed: TP53 mutation
mutated TP53
Allowed: IGHV unmutated
unmutated IGHV
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received:
Cohort 2: Relapsed after and/or refractory to at least one prior therapy
Cannot have received: combined BTK inhibitor and BCL2 inhibitor
Exception: unless at least partial response and no progression/need for new treatment within 2 years of completing fixed-duration combined treatment
Prior treatment with combined BTKi and BCL2i where patients do not achieve at least partial response or progress and need new treatment within 2 years of completing fixed-duration combined treatment
Lab requirements
Blood counts
Absolute neutrophil count >750/L (unless due to marrow infiltration with CLL); Platelet count >30,000/µl, with no platelet transfusion in 2 weeks prior to registration (unless due to marrow infiltration with CLL)
Kidney function
Creatinine clearance >50 mL/min (calculated according to institutional standards or using Cockcroft-Gault, MDRD, or CKD-EPI formula)
Liver function
Total bilirubin ≤1.5 x ULN or ≤3 x ULN for patients with Gilbert's disease; ALT and AST ≤3.0 x ULN, unless clearly due to disease involvement
Adequate renal and hepatic function: * Total bilirubin ≤1.5 x ULN or ≤3 x ULN for patients with Gilbert's disease * Creatinine clearance >50 mL/min (calculated according to institutional standards or using Cockcroft-Gault, MDRD, or CKD-EPI formula) * ALT and AST ≤3.0 x ULN, unless clearly due to disease involvement; Absolute neutrophil count greater than 750 neutrophils/L, unless thought to be due to marrow infiltration with CLL. Platelet count of greater than 30,000/µl, with no platelet transfusion in 2 weeks prior to registration , unless thought to be due to marrow infiltration with CLL.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- M D Anderson Cancer Center · Houston, Texas
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