Ixazomib Citrate and Rituximab in Treating Patients With Indolent B-cell Non-Hodgkin Lymphoma
Part of paid clinical trials in Seattle, Washington.
- Sponsor
- University of Washington
- Study ID
- NCT02339922
- Phase
- PHASE2
- Status
- Active Not Recruiting
Conditions
- Chronic Lymphocytic Leukemia
- Follicular Lymphoma
- Lymphoplasmacytic Lymphoma
- Mantle Cell Lymphoma
- Marginal Zone Lymphoma
- Recurrent Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue
- Refractory Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue
- Small Lymphocytic Lymphoma
- Waldenstrom Macroglobulinemia
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Ixazomib Citrate — DRUGGiven PO
- Laboratory Biomarker Analysis — OTHERCorrelative studies
- Rituximab — BIOLOGICALGiven IV
Study Details
This phase II trial studies how well ixazomib citrate and rituximab work in treating patients with B-cell non-Hodgkin lymphoma that grows slowly (indolent). Ixazomib citrate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Giving ixazomib citrate together with rituximab may work better in treating indolent B-cell non-Hodgkin lymphoma.
Key Dates
- Start date
- May 19, 2016
- Status verified
- Dec 2025
- Primary completion
- Dec 30, 2024
- Completion
- Jan 6, 2031
Study Design
- Enrollment
- 33 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Treatment (ixazomib citrate, rituximab)Patients receive ixazomib citrate orally (PO) on days 1, 8 ,15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Upon completion of 6 cycles of ixazomib citrate therapy, patients also receive rituximab intravenously (IV) once weekly for 4 doses total, followed by ixazomib citrate alone, until disease progression or unacceptable toxicity.
Primary Outcome Measure
Overall Response Rate (ORR) (Complete Response [CR] + Partial Response [PR]) in Patients With Chronic Lymphocytic Leukemia (CLL)/ Small Lymphocytic Lymphoma (SLL), Follicular Lymphoma (FL), Marginal Zone Lymphoma (MZL), and Mantle Cell Lymphoma (MCL) [ Time Frame: Up to 5 years ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington | 98109 | - |
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