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OncoMatch/Clinical Trials/NCT03516617

Acalabrutinib With or Without Obinutuzumab in Treating Patients With Early-Stage Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Is NCT03516617 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Obinutuzumab and Acalabrutinib for chronic lymphocytic leukemia.

Phase 2RecruitingMayo ClinicNCT03516617Data as of May 2026

Treatment: Acalabrutinib · ObinutuzumabThis phase II trials studies how well acalabrutinib with or without obinutuzumab works in treating patients with early-stage chronic lymphocytic leukemia or small lymphocytic lymphoma. Acalabrutinib may stop the growth of cancer cells by blocking some of the enzymes 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. It is not yet known whether giving acalabrutinib with or without obinutuzumab will work better in treating patients with early-stage chronic lymphocytic leukemia or small lymphocytic lymphoma.

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Extracted eligibility criteria

Cancer type

Chronic Lymphocytic Leukemia

Non-Hodgkin Lymphoma

Biomarker criteria

Required: IGHV mutation status

testing for prognostic factors according to the CLL-IPI (including IGVH mutation status); if results for any of the prognostic factors included in the CLL-IPI are unknown including IGVH mutation status results not being available due to a failed laboratory assay, the patient is not eligible

Required: CCND1 wild-type

mantle cell lymphoma must be excluded by demonstrating a negative fluorescence in situ hybridization (FISH) analysis for t(11;14)(IgH/CCND1)

Performance status

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

Prior therapy

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

Cannot have received: chemotherapy

Exception: nutraceutical treatments with no established benefit in CLL (such as epigallocatechin gallate or EGCG, found in green tea or other herbal treatments or supplemental vitamins) and prior corticosteroid therapy for an indication other than CLL/SLL will not be considered 'prior treatment'

Prior chemotherapy or monoclonal antibody based therapy for treatment of CLL or SLL will be considered prior therapy

Cannot have received: monoclonal antibody

Exception: nutraceutical treatments with no established benefit in CLL (such as epigallocatechin gallate or EGCG, found in green tea or other herbal treatments or supplemental vitamins) and prior corticosteroid therapy for an indication other than CLL/SLL will not be considered 'prior treatment'

Prior chemotherapy or monoclonal antibody based therapy for treatment of CLL or SLL will be considered prior therapy

Cannot have received: BCR inhibitor (ibrutinib)

Prior exposure to ibrutinib or to a BCR inhibitor (e.g. Btk or PI3 kinase or Syk inhibitors)

Cannot have received: BCL-2 inhibitor (venetoclax)

prior exposure to ... a BCL-2 inhibitor (e.g. venetoclax)

Lab requirements

Blood counts

ANC >= 1500/mm^3; Platelet count >= 100,000/mm^3; Hemoglobin >= 11.0 g/dL

Kidney function

Creatinine <= 1.5 x ULN

Liver function

AST <= 3 x ULN; total bilirubin <= 1.5 x ULN (or <= 3.0 x ULN with direct bilirubin <= 1.5 x ULN in patients with Gilbert's syndrome)

For high risk and very high risk CLL-IPI (Arms A and B) only: ANC >= 1500/mm^3; Platelet count >= 100,000/mm^3; Hemoglobin >= 11.0 g/dL; AST <= 3 x ULN; Creatinine <= 1.5 x ULN; Total bilirubin <= 1.5 x ULN (or <= 3.0 x ULN with direct bilirubin <= 1.5 x ULN in patients with Gilbert's syndrome); PT, INR, and PTT <= 1.5 X ULN OR if patient is receiving anticoagulant therapy and PT or PTT is within therapeutic range of intended use of coagulants

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

US trial sites

  • Mayo Clinic in Arizona · Scottsdale, Arizona
  • Mayo Clinic in Florida · Jacksonville, Florida
  • Mayo Clinic in Rochester · Rochester, Minnesota

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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