Bendamustine Hydrochloride, Rituximab, Etoposide, and Carboplatin in Treating Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma or Hodgkin Lymphoma
Part of paid clinical trials in Seattle, Washington.
- Sponsor
- University of Washington
- Study ID
- NCT01165112
- Phase
- PHASE1/PHASE2
- Status
- Completed
Conditions
- Recurrent Adult Diffuse Large Cell Lymphoma
- Recurrent Adult Hodgkin Lymphoma
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Bendamustine Hydrochloride — DRUGGiven IV
- Carboplatin — DRUGGiven IV
- Rituximab — BIOLOGICALGiven IV
- Etoposide — DRUGGiven IV
- Laboratory Biomarker Analysis — OTHERCorrelative studies
Study Details
This phase I/II trial is studying the side effects and best dose of bendamustine hydrochloride when given together with carboplatin, etoposide, and rituximab in treating patients with diffuse large B cell lymphoma or Hodgkin lymphoma that has come back after a period of improvement or has not responded to previous treatment. Drugs used in chemotherapy, such as bendamustine hydrochloride, etoposide, and carboplatin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, may block cancer growth by targeting certain cells. Giving bendamustine hydrochloride together with carboplatin, etoposide, and rituximab may kill more cancer cells.
Key Dates
- Start date
- Sep 30, 2010
- Status verified
- Nov 2018
- Primary completion
- Jun 30, 2015
- Completion
- Jun 30, 2015
Study Design
- Enrollment
- 48 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Treatment (chemotherapy and monoclonal antibody therapy)Patients receive bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2, etoposide IV over 60 minutes on days 1-3, and carboplatin IV over 60 minutes on day 1. Patients with CD20+ T-cell lymphoma disease also receive rituximab IV on day 2 or 3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
Primary Outcome Measure
Maximally Tolerated Dose of Bendamustine Hydrochloride That Can be Combined With Rituximab, Carboplatin, and Etoposide Chemotherapy in Patients With Relapsed or Refractory Lymphoid Malignancies [ Time Frame: Up to 5 weeks after the last course ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle | Washington | 98109 | - |