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

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT04883437
Phase
PHASE2
Status
Recruiting
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Conditions

  • Grade 1 Follicular Lymphoma
  • Grade 2 Follicular Lymphoma
  • Grade 3a Follicular Lymphoma
  • Indolent Non-Hodgkin Lymphoma
  • Lymphoplasmacytic Lymphoma
  • Lymphoproliferative Disorder
  • Mantle Cell Lymphoma
  • Marginal Zone Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Acalabrutinib — DRUG
    Given PO
  • Obinutuzumab — BIOLOGICAL
    Given IV
  • Quality-of-Life Assessment — OTHER
    Ancillary studies
  • Questionnaire Administration — OTHER
    Ancillary studies

Study Details

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.

Key Dates

Start date
Sep 3, 2021
Status verified
Feb 2026
Primary completion
Sep 23, 2026
Completion
Jan 15, 2027

Study Design

Enrollment
49 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (acalabrutinib, obinutuzumab)
    INDUCTION PHASE: Patients receive acalabrutinib PO BID on days 1-28. Patients also receive obinutuzumab IV on days 1, 8, and 15 of cycle 3, then on day 1 of cycles 4-8. Treatments repeat every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. FOLLOW-UP PHASE: After cycle 12, patients who are in CR are randomized to either discontinue acalabrutinib or to continue acalabrutinib monotherapy in the absence of disease progression or unacceptable toxicity. Patients with PR or SD after cycle 12 continue acalabrutinib monotherapy in the absence of disease progression or unacceptable toxicity. Patients with disease progression after cycle 12 discontinue study treatment. Patients with disease progression at any time prior to the conclusion of cycle 12 may continue study therapy if they are felt to be benefiting by the treating physician, but not past cycle 12.

Primary Outcome Measure

Complete response (CR) rate [ Time Frame: Up to start of cycle 6 (each cycle = 28 days) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Emory University Hospital/Winship Cancer InstituteAtlantaGeorgia30322
David Reagan
[email protected]
404-251-1275
Jonathon Cohen, MD,MS (PRINCIPAL_INVESTIGATOR)

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By research site
Emory University Hospital/Winship Cancer Institute· Atlanta, GA

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