Refractory/Relapsed Indolent Non-Hodgkin Lymphoma Clinical Trial
Official title:
A Pilot/Feasibility Phase I Study of Bendamustine, Rituximab and Lenalidomide in Patients With Refractory/Relapsed Indolent NHL
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.
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.
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