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.
Men and women >= 18 years of age
Previously untreated follicular lymphoma grade 1-3a with low tumor burden by Groupe d'Etude des Lymphomes Folliculaires (GELF) criteria
Previously untreated follicular lymphoma grade 1-3a with high tumor burden by GELF criteria but who are unable or unwilling to receive standard front-line treatment approaches
Previously untreated marginal zone lymphoma, lymphoplasmacytic lymphoma, or any other indolent B-cell lymphoproliferative disorder with low tumor burden by GELF criteria or who are unable/unwilling to receive more intensive front-line treatment
The presence or history of histologically transformed or co-existing high-grade or aggressive non-Hodgkin lymphoma
Confirmed active or prior central nervous system disease
Prior receipt of lymphoma-directed therapy or prior antibody-based therapy (except for anti-microbial therapy for infection-associated marginal zone lymphoma such as hepatitis C or H pylori)
A short course of steroids is permitted for patients aside from those in the low tumor burden FL cohort. This course may be no more than 14 days and steroids must be discontinued (or tapered to =< 10mg prednisone or equivalent) no later than 3 days after initiation of study treatment. Patients in the low tumor burden FL cohort may not receive corticosteroids as an anti-lymphoma therapy at any time before starting treatment
Single group
Acalabrutinib
DrugGiven PO
Obinutuzumab
Biological/VaccineGiven IV
Quality-of-Life Assessment
Other interventionAncillary studies
Questionnaire Administration
Other interventionAncillary studies
Complete response (CR) rate
Complete response rate will be calculated, and a 95% confidence interval will be estimated using the Clopper-Pearson method.
Incidence of grade 3+ adverse events
Assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Overall response rate
Overall response rate will be calculated, and a 95% confidence interval will be estimated using the Clopper-Pearson method.
CR rate for acalabrutinib monotherapy at end of single-agent run-in
Will be calculated, and a 95% confidence interval will be estimated using the Clopper-Pearson method.
2-year progression free survival (PFS)
PFS will be estimated using Kaplan-Meier methodology. Approximate 95% confidence intervals (CIs) for median PFS will be computed using the Brookmeyer and Crowley method.
Overall survival (OS)
Duration of OS will be estimated using Kaplan-Meier methodology. Approximate 95% CIs for median OS will computed using the Brookmeyer and Crowley method.
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