RecruitingChronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma
Venetoclax-Obinutuzumab +/- Acalabrutinib in R/R CLL
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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
Sponsor: Massachusetts General Hospital
You may qualify if…
- ✓ 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
You may not qualify if…
- ✕ 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.
- ✕ Known hypersensitivity (IgE-mediated) reaction to obinutuzumab or to any of its excipients
- ✕ Participants who are receiving any other investigational agents unless authorized by the overall study principal investigator
- ✕ Known active histological transformation from CLL to an aggressive lymphoma (i.e., Richter's transformation)
- ✕ Active malignancy or systemic therapy for another malignancy within 3 years; local/regional therapy with curative intent such as surgical resection or localized radiation within 3 years of treatment is permitted; active prostate cancer that is considered low-risk and appropriate for continued active surveillance strategy is permitted.
- ✕ Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- ✕ Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment, or any major episode of infection requiring treatment with IV antibiotics or hospitalization (relating to the completion of the course of antibiotics) within 2 weeks prior to Cycle 1, Day 1
Where it's recruiting
Massachusetts
Boston
Source: ClinicalTrials.gov · NCT04560322 · last updated 2026-04-13