NCT01429025

Rituximab, Bendamustine Hydrochloride, and Lenalidomide in Treating Patients With Refractory or Relapsed Indolent Non-Hodgkin Lymphoma

A Pilot/Feasibility Phase I Study of Bendamustine, Rituximab and Lenalidomide in Patients With Refractory/Relapsed Indolent NHL

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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). OBJECTIVES: Primary * To establish the maximum-tolerated dose of lenalidomide in combination with bendamustine and rituximab chemotherapy Secondary * 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.

Conditions

• Refractory/Relapsed Indolent Non-Hodgkin Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	rituximab	IV
DRUG	bendamustine	IV
DRUG	lenalidomide	PO

Timeline

• Start date: 2012-05-01
• Primary completion: 2014-11-01
• Completion: 2019-07-01
• First posted: 2011-09-05
• Last updated: 2019-10-08

Locations

17 sites across 1 country: United States