Rituximab, Bendamustine Hydrochloride, and Lenalidomide in Treating Patients With Refractory or Relapsed Indolent Non-Hodgkin Lymphoma
Part of paid clinical trials in Clive, Iowa.
- Sponsor
- Alliance for Clinical Trials in Oncology
- Study ID
- NCT01429025
- Phase
- PHASE1
- Status
- Completed
Conditions
- Refractory/Relapsed Indolent Non-Hodgkin Lymphoma
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- rituximab — BIOLOGICALIV
- bendamustine — DRUGIV
- lenalidomide — DRUGPO
Study Details
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and help kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as bendamustine hydrochloride, also work in different ways to kill cancer cells or stop them from dividing. Lenalidomide may stop the growth of non-Hodgkin lymphoma by blocking blood flow to the cancer. Giving lenalidomide together with rituximab and bendamustine hydrochloride may kill more cancer cells. PURPOSE: This phase I trial studies the side effects and the best dose of giving lenalidomide together with rituximab and bendamustine hydrochloride in treating patients with refractory or relapsed indolent non-Hodgkin lymphoma.
Key Dates
- Start date
- May 31, 2012
- Status verified
- Oct 2019
- Primary completion
- Nov 30, 2014
- Completion
- Jul 1, 2019
Study Design
- Enrollment
- 26 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: rituximab, bendamustine and lenalidomidePatients receive rituximab IV on day 1, bendamustine IV on days 1-2, and lenalidomide PO on days 1-10. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Primary Outcome Measure
Maximum-tolerated dose of lenalidomide in combination with bendamustine hydrochloride and rituximab [ Time Frame: Up to 28 days ]
Locations (17)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Medical Oncology and Hematology Associates-West Des Moines | Clive | Iowa | 50325 | - |
| Mercy Cancer Center-West Lakes | Clive | Iowa | 50325 | - |
| Iowa Lutheran Hospital | Des Moines | Iowa | 50316 | - |
| Iowa Methodist Medical Center | Des Moines | Iowa | 50309 | - |
| Iowa Oncology Research Association CCOP | Des Moines | Iowa | 50309 | - |
| Medical Oncology and Hematology Associates | Des Moines | Iowa | 50314 | - |
| Medical Oncology and Hematology Associates-Des Moines | Des Moines | Iowa | 50309 | - |
| Mercy Medical Center - Des Moines | Des Moines | Iowa | 50314 | - |
| Mercy Medical Center-Sioux City | Sioux City | Iowa | 51104 | - |
| Siouxland Hematology-Oncology | Sioux City | Iowa | 51101-1733 | - |
| St. Luke's Regional Medical Center | Sioux City | Iowa | 51104 | - |
| Mercy Medical Center-West Lakes | West Des Moines | Iowa | 50266 | - |
| Methodist West Hospital | West Des Moines | Iowa | 50266-7700 | - |
| Mayo Clinic | Rochester | Minnesota | 55905 | - |
| Mid Dakota Clinic | Bismarck | North Dakota | 58501 | - |
| Saint Alexius Medical Center | Bismarck | North Dakota | 58501 | - |
| Sanford Bismarck Medical Center | Bismarck | North Dakota | 58501 | - |