RecruitingPhase 2NCT04883437

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

An Open-Label Phase 2 Trial of Acalabrutinib Plus Obinutuzumab in Patients With Untreated, Low Tumor Burden Follicular Lymphoma and Other Indolent Non-Hodgkin Lymphomas


Sponsor

Emory University

Enrollment

49 participants

Start Date

Sep 3, 2021

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests the combination of acalabrutinib (a targeted BTK inhibitor) and obinutuzumab (a monoclonal antibody against CD20) in patients with previously untreated follicular lymphoma or other slow-growing (indolent) B-cell lymphomas. The goal is to achieve remission without traditional chemotherapy. **You may be eligible if...** - You are 18 or older with previously untreated follicular lymphoma (grades 1–3a), marginal zone lymphoma, lymphoplasmacytic lymphoma, mantle cell lymphoma, or other indolent B-cell lymphoma - You either have low disease burden and prefer a less intensive treatment, or have high disease burden but are unwilling or unable to receive standard first-line therapy - You have at least one measurable affected lymph node or area of disease (1.5 cm or larger) **You may NOT be eligible if...** - You have received any prior treatment for your lymphoma - You have high-grade follicular lymphoma (grade 3b) or aggressive lymphoma - You have serious organ dysfunction - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAcalabrutinib

Given PO

BIOLOGICALObinutuzumab

Given IV

OTHERQuality-of-Life Assessment

Ancillary studies

OTHERQuestionnaire Administration

Ancillary studies


Locations(1)

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

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NCT04883437


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