Lenalidomide and Rituximab in Subjects With Previously Untreated Indolent Non-Hodgkin's Lymphoma

Conditions

• Non Hodgkin's Lymphoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Rituximab — DRUG
  Rituximab 375 mg/m2/wk x 4 weeks, to begin Day 15 of cycle 1. After 4 cycles of therapy if patient does not respond to treatment, the patient will receive a second course of Rituximab.
• Lenalidomide — DRUG
  Lenalidomide will be taken at 20 mg daily, days 1-21 of a 28 day cycle, to be continued until the disease progresses, there are too many side effects, or after twelve cycles if the patient responds to treatment.

Study Details

Lenalidomide has been shown to have single agent activity in indolent Non-Hodgkin's Lymphoma. It is approved for the treatment of multiple myeloma and myelodysplastic syndrome. Rituximab is effective as a single agent and in combination with chemotherapy for indolent Non-Hodgkin's Lymphoma. The purpose of this study is to see how well giving lenalidomide together with rituximab works in treating patients with previously untreated indolent Non Hodgkin's Lymphoma. Lenalidomide will taken at 20 mg daily, days 1-21 of a 28 day cycle, to be continued until the disease progresses, unacceptable side effects or after twelve cycles if the patient is responding well. Rituximab 375 mg/m2/wk x 4 weeks will begin on Day 15 of cycle 1. After 4 cycles of therapy, if patients respond well to treatment, patients will receive a second course of Rituximab. Blood samples will be collected to assess how the immune system is functioning.

Key Dates

Start date

Dec 31, 2010

Status verified

Nov 2025

Primary completion

Sep 12, 2023

Completion

Apr 14, 2024

Study Design

Enrollment

30 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Lenalidomide + Rituximab
  Patients will receive lenalidomide 20 mg daily (oral), on days 1-21 of a 28 day cycle. Rituximab 375 mg/m2 (into the vein) will be administered weekly for 4 doses starting day 15 of cycle 1, to be repeated if patient does not achieve a complete response after cycle 4, on days 1, 8, 15 and 22 of cycle 5.

Primary Outcome Measure

Response Rate to Treatment [ Time Frame: 4 months ]

Locations (2)

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