Actively Recruiting
Acalabrutinib Plus Obinutuzumab for Untreated Low Tumor Burden Follicular Lymphoma and Other Indolent Non-Hodgkin Lymphomas
Led by Emory University · Updated on 2026-02-09
49
Participants Needed
1
Research Sites
16 weeks
Total Duration
On this page
Sponsors
E
Emory University
Lead Sponsor
A
AstraZeneca
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the effects of acalabrutinib and obinutuzumab in patients with previously untreated follicular lymphoma or other indolent non-Hodgkin lymphomas. This phase II trial aims to determine the treatment's effectiveness, tolerability, and impact on quality of life. The study also explores long-term outcomes such as progression-free survival and the impact of discontinuing treatment after a complete response. During the induction phase, patients take acalabrutinib orally twice daily for 28-day cycles, up to 12 cycles, in combination with intravenous obinutuzumab given on specific days during cycles 3 to 8. After 12 cycles, patients who achieve a complete response are randomized to either stop or continue acalabrutinib alone. Those with partial or stable disease continue acalabrutinib monotherapy, while patients with disease progression discontinue treatment unless benefiting as judged by their doctor. Participants undergo regular assessments including tumor measurements and patient-reported outcomes throughout treatment and follow-up visits. After completing treatment, patients are monitored at 30 days, then every 12 weeks for one year, and every 6 months thereafter until disease progression or the start of new lymphoma treatment. Researchers measure response rates, adverse events, quality of life, and survival outcomes to evaluate the treatment's overall impact.
CONDITIONS
Brief 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 who cannot or will not 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 treatment
- Previously untreated mantle cell lymphoma appropriate for watchful waiting or symptomatic but not candidates for or decline standard induction
- Measurable disease defined as at least one lymph node or extranodal site ≥ 1.5 cm in diameter or confirmed bone marrow, blood, splenic, or extranodal involvement
- ECOG performance status of 0-2
- Agreement to use adequate contraception during and after study participation if of childbearing potential
- Negative pregnancy test prior to starting therapy for women of childbearing potential
- Willing and able to participate in all required evaluations and procedures
- Ability to understand study purpose, risks, 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
- Previous lymphoma-directed or antibody-based therapy (except certain anti-microbial treatments)
- Prior malignancy requiring active treatment or recent malignancy with less than 2 years disease-free
- Significant cardiovascular disease including recent heart attack or class 3/4 cardiac disease
- Difficulty swallowing oral medication or gastrointestinal disease affecting absorption
- Known HIV infection or active significant infection within 14 days before treatment
- History of hypersensitivity or anaphylaxis to study drugs or components
- Active bleeding disorders or uncontrolled autoimmune hemolytic anemia or thrombocytopenia
- Recent gastrointestinal ulcers
- Requirement for strong CYP3A4 inhibitors/inducers or anticoagulation with warfarin
- Use of proton pump inhibitors (unless switched to alternatives)
- Recent significant cerebrovascular disease
- Major surgery within 28 days before study drug
- Positive hepatitis B or C PCR or active infection
- Low neutrophil or platelet counts unless related to disease
- Elevated liver enzymes or impaired kidney function
- Pregnancy or breastfeeding
- Concurrent participation in another therapeutic clinical trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 28 days
Participants receive acalabrutinib orally twice daily for 28 days to assess response before combination treatment.
1 visit at start and assessments during the period
Duration - Up to 12 cycles of 28 days each
Participants receive acalabrutinib orally twice daily on days 1-28 and obinutuzumab intravenously on days 1, 8, and 15 of cycle 3, then on day 1 of cycles 4-8, repeated every 28 days for up to 12 cycles if no disease progression or unacceptable toxicity occurs.
Multiple visits for medication administration and assessments every 28 days for up to 12 cycles
Duration - Up to 3 years or until disease progression
After treatment, participants are followed up at 30 days, then every 12 weeks for 1 year, and every 6 months thereafter until disease progression or next anti-lymphoma treatment.
1 visit at 30 days post treatment, then visits every 12 weeks for 1 year, then every 6 months
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
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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