OncoMatch/Clinical Trials/NCT06644183
Roginolisib (IOA-244) With Venetoclax and Rituximab for Refractory/Relapsed Chronic Lymphocytic Leukemia (CLL)
Is NCT06644183 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Roginolisib and Venetoclax for leukemia.
Treatment: Roginolisib · Venetoclax · Rituximab — This research study will test the safety and anticancer activity of the combination of three drugs (Roginolisib, Venetoclax, and Rituximab) for participants with relapsed or refractory Chronic Lymphocytic Leukemia (CLL). The names of the study drugs involved in this study are: * Roginolisib (a novel type of PI3-kinase delta inhibitor) * Venetoclax (a type of B-cell lymphoma 2 inhibitor) * Rituximab (a type of monoclonal antibody)
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Chronic Lymphocytic Leukemia
Tumor Agnostic
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: covalent BTK inhibitor
Patients must have received at least two prior therapies for CLL including systemic therapy containing a covalent BTK inhibitor.
Cannot have received: BCL2 inhibitor (venetoclax)
Patients who have received prior treatment with venetoclax or PI3K inhibitors in the last 6 months.
Cannot have received: PI3K inhibitor
Patients who have received prior treatment with venetoclax or PI3K inhibitors in the last 6 months.
Lab requirements
Blood counts
Platelet count ≥50 x 10^9/L^^^; ^^^Thrombocytopenia due to marrow involvement of CLL: > 30 x 10^9/L for the safety run-in, and 20 x 10^9/L for the randomized portion of the study
Kidney function
Creatinine clearance ≥ 60 mL/min**; ** calculated by the Cockcroft Gault formula or measured by 24 hours urine collection
Liver function
Total bilirubin ≤ 1.5 ×institutional upper limit of normal (ULN)*; AST(SGOT)/ALT(SGPT) ≤3.0 × institutional ULN; *unless increase attributed to leukemic organ involvement, hemolysis or Gilbert's syndrome. Patients who are < 75 years may have bilirubin of ≤ 3.0 × ULN
Participants must meet the following organ and marrow function as defined below: * Platelet count ≥50 x 10^9/L^^^ * Total bilirubin ≤ 1.5 ×institutional upper limit of normal (ULN)* * AST(SGOT)/ALT(SGPT) ≤3.0 × institutional ULN * Creatinine clearance ≥ 60 mL/min** * ^^^Thrombocytopenia due to marrow involvement of CLL: > 30 x 10^9/L for the safety run-in, and 20 x 10^9/L for the randomized portion of the study * *unless increase attributed to leukemic organ involvement, hemolysis or Gilbert's syndrome. Patients who are < 75 years may have bilirubin of ≤ 3.0 × ULN * ** calculated by the Cockcroft Gault formula or measured by 24 hours urine collection
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Dana-Farber Cancer Institute · Boston, Massachusetts
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