OncoMatch/Clinical Trials/NCT04560322
Venetoclax-Obinutuzumab +/- Acalabrutinib in R/R CLL
Is NCT04560322 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Venetoclax and Obinutuzumab for chronic lymphocytic leukemia.
Treatment: Venetoclax · Obinutuzumab · Acalabrutinib — This research study is studying a combination of drugs as a possible treatment for chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The names of the study drugs involved in this study are: * obinutuzumab * venetoclax * acalabrutinib
Check if I qualifyExtracted eligibility criteria
Cancer type
Chronic Lymphocytic Leukemia
Non-Hodgkin Lymphoma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: systemic therapy
Participants must have received prior systemic therapy for CLL
Cannot have received: BTK inhibitor (acalabrutinib)
Exception: Patients with undetectable MRD by flow cytometry at 10 (peripheral blood or bone marrow) or CR from prior treatment with BCL2 inhibitor (with or without BTK inhibitor) are eligible. Note: Patients who received prior BTK inhibitor therapy alone are not eligible.
Prior therapy with a BTK inhibitor (e.g. acalabrutinib) or BCL2 inhibitor (e.g. venetoclax), with the following exception: Patients with undetectable MRD by flow cytometry at 10 (peripheral blood or bone marrow) or CR from prior treatment with BCL2 inhibitor (with or without BTK inhibitor) are eligible. Note: Patients who received prior BTK inhibitor therapy alone are not eligible.
Cannot have received: BCL2 inhibitor (venetoclax)
Exception: Patients with undetectable MRD by flow cytometry at 10 (peripheral blood or bone marrow) or CR from prior treatment with BCL2 inhibitor (with or without BTK inhibitor) are eligible.
Prior therapy with a BTK inhibitor (e.g. acalabrutinib) or BCL2 inhibitor (e.g. venetoclax), with the following exception: Patients with undetectable MRD by flow cytometry at 10 (peripheral blood or bone marrow) or CR from prior treatment with BCL2 inhibitor (with or without BTK inhibitor) are eligible.
Lab requirements
Blood counts
absolute neutrophil count ≥1,000/mcL; platelets ≥75,000/mcL OR >20,000/mcL if thrombocytopenia is clearly due to disease under study (per investigator discretion)
Kidney function
creatinine within normal institutional limits OR creatinine clearance ≥30 mL/min according to the Cockcroft-Gault Equation for participants with creatinine levels above institutional normal
Liver function
total bilirubin ≤2 × institutional upper limit of normal unless considered secondary to Gilbert's syndrome, in which case ≤3 x ULN; AST(SGOT)/ALT(SGPT) ≤2 × institutional upper limit of normal
Participants must have adequate organ function as defined below: total bilirubin ≤2 × institutional upper limit of normal unless considered secondary to Gilbert's syndrome, in which case ≤3 x ULN; AST(SGOT)/ALT(SGPT) ≤2 × institutional upper limit of normal; creatinine within normal institutional limits OR creatinine clearance ≥30 mL/min according to the Cockcroft-Gault Equation for participants with creatinine levels above institutional normal. Participants must have adequate marrow function as defined below (unless clearly due to disease under study per investigator discretion): absolute neutrophil count ≥1,000/mcL; platelets ≥75,000/mcL OR >20,000/mcL if thrombocytopenia is clearly due to disease under study (per investigator discretion).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Massachusetts General Hospital Cancer Center · Boston, Massachusetts
- Beth Israel Deaconess Medical Center · Boston, Massachusetts
- Dana-Farber Cancer Institute · Boston, Massachusetts
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify