Actively Recruiting
Acalabrutinib and Obinutuzumab for the Treatment of Previously Untreated Follicular Lymphoma or Other Indolent Non-Hodgkin Lymphomas
Led by Emory University · Updated on 2026-02-09
49
Participants Needed
1
Research Sites
280 weeks
Total Duration
On this page
Sponsors
E
Emory University
Lead Sponsor
A
AstraZeneca
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase II trial studies the effect of acalabrutinib and obinutuzumab in treating patients with follicular lymphoma or other indolent non-Hodgkin lymphoma for which the patient has not received treatment in the past (previously untreated). Acalabrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Immunotherapy with obinutuzumab may induce changes in body's immune system and may interfere with the ability of cancer cells to grow and spread. Giving acalabrutinib and obinutuzumab may kill more cancer cells.
CONDITIONS
Official Title
Acalabrutinib and Obinutuzumab for the Treatment of Previously Untreated Follicular Lymphoma or Other Indolent Non-Hodgkin Lymphomas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women 18 years of age or older
- Previously untreated follicular lymphoma grade 1-3a with low tumor burden by GELF criteria
- Previously untreated follicular lymphoma grade 1-3a with high tumor burden by GELF criteria but unable or unwilling to receive standard front-line treatments
- Previously untreated marginal zone lymphoma, lymphoplasmacytic lymphoma, or other indolent B-cell lymphoproliferative disorders with low tumor burden by GELF criteria or unable/unwilling to receive intensive front-line treatments
- Previously untreated mantle cell lymphoma suitable for watchful waiting or symptomatic but not candidates for or declined standard induction
- Measurable or assessable disease with at least one involved lymph node or extranodal site measuring 1.5 cm or larger
- ECOG performance status of 0-2
- Women of childbearing potential and men must agree to use adequate contraception during and after the study
- Women of childbearing potential must have a negative pregnancy test before starting therapy
- Willing and able to participate in all study evaluations and procedures
- Able to understand and provide informed consent
You will not qualify if you...
- History or presence of transformed or high-grade aggressive non-Hodgkin lymphoma
- Active or prior central nervous system disease
- Prior lymphoma-directed or antibody-based therapy (except certain anti-microbial treatments)
- Prior malignancy requiring active treatment within 2 years except certain treated skin or cervical cancers
- Significant cardiovascular disease including recent heart attack or class 3/4 heart failure
- Difficulty swallowing oral medication or gastrointestinal diseases affecting absorption
- Known HIV infection or active significant infection within 14 days before cycle 1
- Known allergy or hypersensitivity to study drugs or components
- Active bleeding disorders or uncontrolled autoimmune blood conditions
- Recent gastrointestinal ulcer diagnosed within 3 months before screening
- Use of strong CYP3A4 inhibitors/inducers or certain anticoagulants
- Use of proton pump inhibitors (switching to other acid reducers allowed)
- Recent significant cerebrovascular events within 6 months
- Major surgery within 28 days before first dose
- Positive hepatitis B or C viral tests not meeting specified criteria
- Low neutrophil or platelet counts unless due to underlying disease
- Elevated liver enzymes or impaired kidney function
- Pregnant or breastfeeding
- Concurrent participation in another therapeutic clinical trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Actively Recruiting
Research Team
J
Jonathon Cohen, MD, MS
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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