Obinutuzumab and Ibrutinib as Front Line Therapy in Treating Patients With Indolent Non-Hodgkin's Lymphomas

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Study ID
NCT03198026
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Ann Abor Stage III B-Cell Non-Hodgkin Lymphoma
  • Ann Arbor Stage II Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue
  • Ann Arbor Stage II Follicular Lymphoma
  • Ann Arbor Stage II Nodal Marginal Zone Lymphoma
  • Ann Arbor Stage III Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue
  • Ann Arbor Stage III Follicular Lymphoma
  • Ann Arbor Stage III Nodal Marginal Zone Lymphoma
  • Ann Arbor Stage IV B-Cell Non-Hodgkin Lymphoma
  • Ann Arbor Stage IV Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue
  • Ann Arbor Stage IV Follicular Lymphoma
  • Ann Arbor Stage IV Nodal Marginal Zone Lymphoma
  • Grade 1 Follicular Lymphoma
  • Grade 2 Follicular Lymphoma
  • Grade 3a Follicular Lymphoma
  • Indolent Non-hodgkin Lymphoma
  • Non-Hodgkin's Lymphoma
  • Stage II Splenic Marginal Zone Lymphoma
  • Stage III Splenic Marginal Zone Lymphoma
  • Stage IV Splenic Marginal Zone Lymphoma

Eligibility Criteria

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

Interventions

  • Ibrutinib — DRUG
    Given PO
  • Obinutuzumab — BIOLOGICAL
    Given IV
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies

Study Details

This phase II trial studies how well obinutuzumab and ibrutinib work as front line therapy in treating patients with indolent non-Hodgkin's lymphoma. Monoclonal antibodies, such as obinutuzumab, may interfere with the ability of cancer cells to grow and spread. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving obinutuzumab and ibrutinib may work better in treating patients with non-Hodgkin's lymphomas.

Key Dates

Start date
Feb 20, 2018
Status verified
Feb 2026
Primary completion
Sep 11, 2026
Completion
Feb 20, 2032

Study Design

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

Arms

  • Experimental: Treatment (ibrutinib, obinutuzumab)
    Patients receive ibrutinib orally (PO) once daily (QD) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also receive obinutuzumab intravenously (IV) on days 1, 8, and 15 of cycle 1 and day 1 of subsequent cycles. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Beginning 2 months after cycle 6, patients with stable disease will continue to receive obinutuzumab every 2 months for a total of 12 doses. After completion of study treatment, patients are followed up monthly for 1 year, every 3-6 months for 4 years, and then annually for up to 2 years.

Primary Outcome Measure

Overall response rate in patients with newly diagnosed indolent lymphoma requiring treatment, including complete response and partial response [ Time Frame: Up to 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Sidney Kimmel Cancer Center at Thomas Jefferson UniversityPhiladelphiaPennsylvania19107-

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Sidney Kimmel Cancer Center at Thomas Jefferson University· Philadelphia, PA

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