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OncoMatch/Clinical Trials/NCT07014917

Intermittent Versus Continuous Venetoclax With Acalabrutinib for CLL/SLL

Is NCT07014917 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Venetoclax and Acalabrutinib for chronic lymphocytic leukemia.

Phase 2RecruitingZulfa OmerNCT07014917Data as of May 2026

Treatment: Venetoclax · Acalabrutinib · Venetoclax · AcalabrutinibThis is a randomized Phase II study of intermittent versus continuous venetoclax therapy with Acalabrutinib in previously untreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)

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Extracted eligibility criteria

Cancer type

Chronic Lymphocytic Leukemia

Non-Hodgkin Lymphoma

Biomarker criteria

Allowed: XPO1 any mutation

genomic features (XPO1, NOTCH1, SF3B1, FBXW7, MYD88, BIRC3, TRAF3, NFKBIE, SAMHD1, POT1, HIST1H1E, CHD2, ZMYM3, EGR2 and others) that are suggestive of CLL

Allowed: NOTCH1 any mutation

genomic features (XPO1, NOTCH1, SF3B1, FBXW7, MYD88, BIRC3, TRAF3, NFKBIE, SAMHD1, POT1, HIST1H1E, CHD2, ZMYM3, EGR2 and others) that are suggestive of CLL

Allowed: SF3B1 any mutation

genomic features (XPO1, NOTCH1, SF3B1, FBXW7, MYD88, BIRC3, TRAF3, NFKBIE, SAMHD1, POT1, HIST1H1E, CHD2, ZMYM3, EGR2 and others) that are suggestive of CLL

Allowed: FBXW7 any mutation

genomic features (XPO1, NOTCH1, SF3B1, FBXW7, MYD88, BIRC3, TRAF3, NFKBIE, SAMHD1, POT1, HIST1H1E, CHD2, ZMYM3, EGR2 and others) that are suggestive of CLL

Allowed: MYD88 any mutation

genomic features (XPO1, NOTCH1, SF3B1, FBXW7, MYD88, BIRC3, TRAF3, NFKBIE, SAMHD1, POT1, HIST1H1E, CHD2, ZMYM3, EGR2 and others) that are suggestive of CLL

Allowed: BIRC3 any mutation

genomic features (XPO1, NOTCH1, SF3B1, FBXW7, MYD88, BIRC3, TRAF3, NFKBIE, SAMHD1, POT1, HIST1H1E, CHD2, ZMYM3, EGR2 and others) that are suggestive of CLL

Allowed: TRAF3 any mutation

genomic features (XPO1, NOTCH1, SF3B1, FBXW7, MYD88, BIRC3, TRAF3, NFKBIE, SAMHD1, POT1, HIST1H1E, CHD2, ZMYM3, EGR2 and others) that are suggestive of CLL

Allowed: NFKBIE any mutation

genomic features (XPO1, NOTCH1, SF3B1, FBXW7, MYD88, BIRC3, TRAF3, NFKBIE, SAMHD1, POT1, HIST1H1E, CHD2, ZMYM3, EGR2 and others) that are suggestive of CLL

Allowed: SAMHD1 any mutation

genomic features (XPO1, NOTCH1, SF3B1, FBXW7, MYD88, BIRC3, TRAF3, NFKBIE, SAMHD1, POT1, HIST1H1E, CHD2, ZMYM3, EGR2 and others) that are suggestive of CLL

Allowed: POT1 any mutation

genomic features (XPO1, NOTCH1, SF3B1, FBXW7, MYD88, BIRC3, TRAF3, NFKBIE, SAMHD1, POT1, HIST1H1E, CHD2, ZMYM3, EGR2 and others) that are suggestive of CLL

Allowed: HIST1H1E any mutation

genomic features (XPO1, NOTCH1, SF3B1, FBXW7, MYD88, BIRC3, TRAF3, NFKBIE, SAMHD1, POT1, HIST1H1E, CHD2, ZMYM3, EGR2 and others) that are suggestive of CLL

Allowed: CHD2 any mutation

genomic features (XPO1, NOTCH1, SF3B1, FBXW7, MYD88, BIRC3, TRAF3, NFKBIE, SAMHD1, POT1, HIST1H1E, CHD2, ZMYM3, EGR2 and others) that are suggestive of CLL

Allowed: ZMYM3 any mutation

genomic features (XPO1, NOTCH1, SF3B1, FBXW7, MYD88, BIRC3, TRAF3, NFKBIE, SAMHD1, POT1, HIST1H1E, CHD2, ZMYM3, EGR2 and others) that are suggestive of CLL

Allowed: EGR2 any mutation

genomic features (XPO1, NOTCH1, SF3B1, FBXW7, MYD88, BIRC3, TRAF3, NFKBIE, SAMHD1, POT1, HIST1H1E, CHD2, ZMYM3, EGR2 and others) that are suggestive of CLL

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Lab requirements

Blood counts

ANC ≥1,000/mcL (or ≥500/mcL if neutropenia due to CLL bone marrow disease; no lower threshold if WBC > 50 x 10^9/L); Platelets ≥30,000/mcL (or ≥10,000/mcL if thrombocytopenia due to CLL bone marrow disease)

Kidney function

Creatinine clearance (Cockcroft) ≥30 mL/min/1.73 m2

Liver function

Total bilirubin ≤1.5 x ULN unless Gilbert's syndrome; AST and ALT ≤3 × ULN

ANC ≥1,000/mcL, unless if neutropenia is due to extensive underlying CLL bone marrow disease then platelet threshold will be ANC ≥500/mcL unless WBC is > to 50 x 109/L. If WBC is > to 50 x 109/L there will be no lower threshold of ANC. Use of steroids for disease control is allowed. Platelets ≥30,000/mcL unless thrombocytopenia is due to extensive underlying CLL bone marrow disease platelets threshold will be ≥ 10, 000/mcl. Use of steroids for disease control is allowed. Total bilirubin ≤1.5 x ULN unless directly attributable to Gilbert's syndrome. AST and ALT ≤3 × ULN. Creatinine clearance (Cockcroft) ≥30 mL/min/1.73 m2

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • University of Cincinnati · Cincinnati, Ohio

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