OncoMatch/Clinical Trials/NCT05388006
Acalabrutinib, Venetoclax and Durvalumab for the Treatment of Richter Transformation From Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Is NCT05388006 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Durvalumab and Acalabrutinib for chronic lymphocytic leukemia.
Treatment: Acalabrutinib · Durvalumab · Venetoclax — This phase II trial tests whether acalabrutinib, venetoclax, and durvalumab work in treating patients with Richter transformation from chronic lymphocytic leukemia or small lymphocytic lymphoma. Richter transformation is a rare condition in which chronic lymphocytic leukemia or small lymphocytic lymphoma changes into a fast-growing type of lymphoma. Acalabrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Immunotherapy with monoclonal antibodies, such as durvalumab, 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, venetoclax, and durvalumab may help improve survival in patients with Richter transformation.
Check if I qualifyExtracted eligibility criteria
Cancer type
Chronic Lymphocytic Leukemia
Non-Hodgkin Lymphoma
Biomarker criteria
Required: CCND1 wild-type
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: Richter transformation-directed therapy
If Richter's transformation (RT) developed from prior untreated CLL and has not received any RT directed therapy, then patient is not eligible
Cannot have received: durvalumab (durvalumab)
Prior durvalumab treatment. Note: If patients were treated with other prior PD1 blockade or PDL1 blockade, they will still be eligible
Lab requirements
Blood counts
Absolute neutrophil count >= 0.7 x 10^9/L unless marrow involved by CLL or RT, then ANC >= 0.3 x 10^9/L; Platelet count >= 40 x 10^9/L unless marrow involved by CLL or RT, then platelet >= 30 x 10^9/L without transfusion <= 1 week prior to study registration; Hemoglobin >= 8 unless marrow involved by CLL or RT, then Hgb >= 7 without transfusion <= 1 week prior to study registration
Kidney function
Calculated creatinine clearance of > 30 mL/min by the Cockcroft-Gault formula
Liver function
Total bilirubin <= 1.5 x ULN unless due to confirmed Gilbert's disease; AST or ALT <= 2.5 x ULN unless liver metastases are present, in which case <= 5 x ULN
Absolute neutrophil count >= 0.7 x 10^9/L unless marrow was involved by CLL or RT, then absolute neutrophil count (ANC) >= 0.3 x 10^9/L (<= 14 days prior to registration); Platelet count >= 40 x 10^9/L unless marrow was involved by CLL or RT, then platelet >= 30 x 10^9/L without transfusion <= 1 week prior to study registration (<= 14 days prior to registration); Hemoglobin (Hgb) >= 8 unless marrow was involved by CLL or RT, then Hgb >= 7 without transfusion <= 1 week prior to study registration (<= 14 days prior to registration); Total bilirubin <= 1.5 x upper limit of normal (ULN) unless due to confirmed Gilbert's disease; AST or ALT <= 2.5 X ULN unless liver metastases are present, in which case it must be <= 5 x ULN (<= 14 days prior to registration); Calculated creatinine clearance of > 30 mL/min by the Cockcroft-Gault formula (<= 14 days prior to registration)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Stanford Cancer Institute Palo Alto · Palo Alto, California
- Mayo Clinic in Rochester · Rochester, Minnesota
- Washington University School of Medicine · St Louis, Missouri
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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