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Recruiting Phase 2 NCT04883437

NCT04883437 Acalabrutinib and Obinutuzumab for the Treatment of Previously Untreated Follicular Lymphoma or Other Indolent Non-Hodgkin Lymphomas

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Clinical Trial Summary
NCT ID NCT04883437
Status Recruiting
Phase Phase 2
Sponsor Emory University
Condition Grade 1 Follicular Lymphoma
Study Type INTERVENTIONAL
Enrollment 49 participants
Start Date 2021-09-03
Primary Completion 2026-09-23

Trial Parameters

Condition Grade 1 Follicular Lymphoma
Sponsor Emory University
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 49
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2021-09-03
Completion 2026-09-23
Interventions
AcalabrutinibObinutuzumabQuality-of-Life Assessment

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Brief Summary

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.

Eligibility Criteria

Inclusion Criteria: * Men and women \>= 18 years of age * Patients will need to have one of the following clinical scenarios: * 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 * Previously untreated mantle cell lymphoma who would otherwise be appropriate candidates for watchful waiting OR who have symptomatic disease but are not candidates for or decline standard induction approaches * Patients with previously untreated low tumor burden FL (criterion above) must have measurable and/

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