NCT04855695 · Austin I Kim
Avo In R/R And Previously Untreated MCL
What this study 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).
View original scientific description
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).
Interventions
DRUG
Acalabrutinib
Each study drug is given according to a different schedule: Acalabrutinib: Oral, dosage per protocol, start cycle 1 and beyond according to schedule outlined in protocol
DRUG
Venetoclax
Venetoclax: oral. daily, dosage per protocol, start cycle 3 and beyond according to schedule outlined in protocol
DRUG
Obinutuzumab
Obinutuzumab: intravenous infusion, dosage per protocol, drug during cycles 2 and beyond according to schedule outlined in protocol
Primary outcome measures
Recommended Phase 2 Dose for acalabrutinib
Time frame: 5 months
The RP2D will be defined as the highest dose level for which there are no more than 1/6 DLTs observed.
Complete Remission Rate
Time frame: 7 Months
Complete remission (CR) rate after 7 cycles of treatment with AVO in treatment naïve (TN) transplant ineligible MCL and TN transplant-eligible, TP53 mutated MCL, cohort B. CR rate after 7 cycles of treatment with AVO in TN TP53-mutated MCL, expansion cohort D. Complete remission (CR) is defined radiographically using 2014 Lugano criteria and a negative bone marrow biopsy by histology, immunohistochemistry, and flow cytometry, if bone marrow was initially involved by MCL at screening. CR, a primary endpoint measured after 7 cycles of AVO, does not incorporate minimal residual disease (MRD) testing
MRD negative complete remission rate
Time frame: 7 months
Minimal residual disease (MRD) negative (\<1 in 106 cells) CR rate after 7 cycles of treatment with AVO in TN transplant-eligible, TP53 wild type MCL, cohort C
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
- Participants must meet the following criteria on screening examination to be eligible to participate in the study:
- Participants must have histologically determined mantle cell lymphoma with pathologic review at the participating institutions, that has either:
- Relapsed or primary refractory after at least one line of therapy including anti-CD20 monoclonal antibody treatment (part A) or; Had no previous anti-lymphoma therapy other than corticosteroids or radiotherapy (parts B and C).
- Participants in part A, relapsed or refractory following prior therapy, may have had a prior autologous or allogeneic stem cell transplant and may have been treated with chimeric antigen receptor T-cells (CAR T-cells).
- Participants in parts B and C, without prior anti-lymphoma therapy, must require treatment as defined by any of the following criteria:
- Symptomatic adenopathy or splenomegaly
- Local symptoms due to extranodal disease
- Organ function impairment due
Where
- Chicago, Illinois
- Boston, Massachusetts
Collaborators
Roche-Genentech, AstraZeneca
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 Jan 21, 2026 · Source of record for eligibility and locations