NCT04560322 · Massachusetts General Hospital
Venetoclax-Obinutuzumab +/- Acalabrutinib in R/R CLL
What this study is about
This research study is studying a combination of drugs as a possible treatment for chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
View original scientific description
This research study is studying a combination of drugs as a possible treatment for chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
Interventions
DRUG
Venetoclax
Tablet, taken by mouth
DRUG
Obinutuzumab
Intravenous infusion
DRUG
Acalabrutinib
Capsule, taken by mouth
Primary outcome measures
Percentage of participants alive at 1 year
Time frame: 1 year
Percent of participants with high and intermediate risk relapsed/refractory CLL who are alive at 1 year. The percent of patients who are alive at one-year (rOS) will be measured by monitoring you in clinic. An rOS of at least 90% will be considered promising whereas the rOS of 75% or less will be considered non-promising.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Boston, Massachusetts
Collaborators
Genentech, Inc.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 13, 2026 · Source of record for eligibility and locations