Actively Recruiting
Avo In R/R And Previously Untreated MCL
Led by Austin I Kim · Updated on 2026-01-21
72
Participants Needed
3
Research Sites
339 weeks
Total Duration
On this page
Sponsors
A
Austin I Kim
Lead Sponsor
R
Roche-Genentech
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research study is evaluating the combination of three drugs - acalabrutinib, venetoclax, and obinutuzumab - as a possible treatment for relapsed or refractory and untreated mantle cell lymphoma (MCL). The names of the study drugs involved in this study are: * Acalabrutinib * Venetoclax * Obinutuzumab
CONDITIONS
Official Title
Avo In R/R And Previously Untreated MCL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have biopsy-confirmed mantle cell lymphoma with pathology review
- For relapsed/refractory patients: must have had at least one prior therapy including anti-CD20 antibody
- For untreated patients: no prior lymphoma therapy except corticosteroids or radiotherapy
- Untreated patients must need treatment due to symptoms, organ impairment, or systemic B symptoms
- Specific genetic markers (TP53 mutation or wild type) determine eligibility for study parts B, C, or D
- Measurable disease by imaging or marrow involvement with related blood count abnormalities
- Age 18 years or older
- ECOG performance status 0 to 2
- Adequate organ and marrow function with defined blood count and chemistry levels
- Willingness to provide bone marrow and blood samples before and during treatment
- Women of childbearing potential and men with partners must agree to use effective contraception
- Ability to understand and sign informed consent
You will not qualify if you...
- Progression or relapse after prior BTK inhibitor or BCL2 inhibitor treatment
- Use of other investigational agents within 4 weeks prior to study
- Concurrent systemic immunosuppressant therapy or high-dose corticosteroids
- History of severe allergic reactions to study drugs or similar compounds
- History of other malignancies unless treated with curative intent and low recurrence risk
- Known brain or leptomeningeal metastases
- Recent major surgery or significant trauma within 4 weeks
- Vaccination with live vaccines within 28 days before study entry
- Active HIV, hepatitis B or C infections or positive viral PCR tests
- Active infections requiring intravenous antimicrobials at screening
- Uncontrolled medical or psychiatric illness that limits study compliance
- Pregnant or breastfeeding women
- Known bleeding disorders or recent bleeding gastrointestinal ulcers
- History of stroke or intracranial hemorrhage within 6 months
- Requirement for warfarin or vitamin K antagonist anticoagulants
- Significant cardiovascular disease including recent heart attack or unstable angina
- Concurrent treatment with strong CYP3A or P-gp inhibitors or inducers without washout
- Inability to swallow capsules or significant gastrointestinal absorption issues
- Significant comorbid conditions or diseases increasing study risk
- History or ongoing progressive multifocal leukoencephalopathy (PML)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Actively Recruiting
2
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
3
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
Research Team
A
Austin I Kim, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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