OncoMatch/Clinical Trials/NCT05943496
Tafasitamab, Acalabrutinib, and Obinutuzumab for the Treatment of Previously Untreated Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma
Is NCT05943496 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Obinutuzumab and Tafasitamab for chronic lymphocytic leukemia.
Treatment: Acalabrutinib · Obinutuzumab · Tafasitamab — This phase Ib trial tests the safety and effectiveness of tafasitamab, acalabrutinib, and obinutuzumab in treating patients with previously untreated chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). CLL and SLL are types of cancer that develops from a specific white blood cell called B cells or B lymphocytes. Tafasitamab and obinutuzumab are monoclonal antibodies that may interfere with the ability of cancer cells to grow and spread. Acalabrutinib is in a class of medications called kinase inhibitors. It blocks a protein called BTK, which is present on B-cell cancers such as CLL at abnormal levels. This may help keep cancer cells from growing and spreading. Giving tafasitamab, acalabrutinib, and obinutuzumab may kill more cancer cells in patients with previously untreated CLL and SLL.
Check if I qualifyExtracted eligibility criteria
Cancer type
Chronic Lymphocytic Leukemia
Biomarker criteria
Required: IGH detectable immunoglobulin heavy gene signature (detectable)
Baseline detectable immunoglobulin heavy (IGH) gene signature determined as part of clonoSEQ for minimal residual disease (MRD) testing
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: CLL-directed treatment
Exception: Use of corticosteroids (or ongoing prednisone ≤ 20 mg daily, or equivalent) for symptom control are permitted. Enrollment will be considered for those individuals that can taper ongoing use of a corticosteroid at > 20 mg daily to 0 mg within 14 days after C1D1
Any previous CLL-directed treatment. Use of corticosteroids (or ongoing prednisone ≤ 20 mg daily, or equivalent) for symptom control are permitted. Enrollment will be considered for those individuals that can taper ongoing use of a corticosteroid at > 20 mg daily to 0 mg within 14 days after C1D1
Lab requirements
Blood counts
Absolute neutrophil count (ANC) > 1,000/mm^3 (uL); Platelet count > 50,000/mm^3 (uL)
Kidney function
Serum creatinine ≤ 2 x ULN or creatinine clearance (CrCl) ≥ 40 mL/min by Cockcroft-Gault
Liver function
AST ≤ 3 x ULN; ALT ≤ 3 x ULN; ALP ≤ 3 x ULN; Total bilirubin ≤ 2.5 x ULN unless documented history of Gilbert's syndrome
Absolute neutrophil count (ANC) > 1,000/mm^3 (uL); Platelet count > 50,000/mm^3 (uL). Serum creatinine ≤ 2 x ULN or creatinine clearance (CrCl) ≥ 40 mL/min by Cockcroft-Gault. AST ≤ 3 x ULN; ALT ≤ 3 x ULN; ALP ≤ 3 x ULN; Total bilirubin ≤ 2.5 x ULN unless documented history of Gilbert's syndrome
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- OHSU Knight Cancer Institute · Portland, Oregon
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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