Rituximab, Bendamustine Hydrochloride, and Lenalidomide in Treating Patients With Refractory or Relapsed Indolent Non-Hodgkin Lymphoma
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|ClinicalTrials.gov Identifier: NCT01429025|
Recruitment Status : Completed
First Posted : September 5, 2011
Last Update Posted : October 8, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Refractory/Relapsed Indolent Non-Hodgkin Lymphoma||Biological: rituximab Drug: bendamustine Drug: lenalidomide||Phase 1|
This is a pilot/feasibility study of bendamustine, rituximab, and lenalidomide combination with a goal of assessing maximum tolerated dose, safety and feasibility of this combination. Patients receive rituximab IV over 5-8 hours on day 1, bendamustine hydrochloride IV over 30-60 minutes on days 1-2, and lenalidomide orally (PO) on days 1-10. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Ancillary treatment is available per the protocol (eg, supportive care for rituximab infusions).
- To establish the maximum-tolerated dose of lenalidomide in combination with bendamustine and rituximab chemotherapy
- To evaluate the toxicity profile of lenalidomide in combination with bendamustine and rituximab chemotherapy
- To assess progression-free survival
- To assess the overall and complete response rates of lenalidomide in combination with bendamustine and rituximab in patients with relapsed/refractory indolent non-Hodgkin lymphoma (NHL)
Patients may undergo blood sample collection at baseline and periodically during treatment for correlative studies. Tumor tissue samples may also be collected.Patients are followed up for up to 5 years post-registration.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot/Feasibility Phase I Study of Bendamustine, Rituximab and Lenalidomide in Patients With Refractory/Relapsed Indolent NHL|
|Actual Study Start Date :||May 2012|
|Actual Primary Completion Date :||November 2014|
|Actual Study Completion Date :||July 1, 2019|
Experimental: rituximab, bendamustine and lenalidomide
Patients 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.
- Maximum-tolerated dose of lenalidomide in combination with bendamustine hydrochloride and rituximab [ Time Frame: Up to 28 days ]
- Toxicity profile [ Time Frame: Up to 5 years ]
- Progression-free survival [ Time Frame: Time from registration to the earliest date of documented disease progression or death due to any cause, assessed up to 5 years ]
- Overall response rate [ Time Frame: Up to 5 years ]
- Complete response rate [ Time Frame: Up to 5 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01429025
|Study Chair:||Grzegorz S. Nowakowski, MD||Mayo Clinic|