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Recruiting Phase 2 NCT04560322

Venetoclax-Obinutuzumab +/- Acalabrutinib in R/R CLL

Trial Parameters

Condition Chronic Lymphocytic Leukemia
Sponsor Massachusetts General Hospital
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 40
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2020-10-19
Completion 2026-03-01
Interventions
VenetoclaxObinutuzumabAcalabrutinib

Brief Summary

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

Eligibility Criteria

Inclusion Criteria: * Diagnosis of CLL or SLL according to WHO criteria * Participants must require therapy according to iwCLL 2018 guidelines * Participants must have ≥ 2 points (high or intermediate risk disease) according to the CLL BALL Risk Model: * Beta-2 microglobulin If ≥ 5 mg/L, assign 1 point * Lactate dehydrogenase If \>institutional upper limit of normal, assign 1 point * Hemoglobin If \<11 g/dL (female) or \<12 g/dL (male), assign 1 point * Time from start of last therapy If \<24 months, assign 1 point, If 4 points, patient is high risk, If 2-3 points, patient is intermediate risk, If 0-1 points, patient is low risk * Participants must have received prior systemic therapy for CLL * Age over 18 years * ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A) * 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(

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