Combined Rituximab and Lenalidomide Treatment for Untreated Patients With Follicular Lymphoma

• Status: Active, not recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the effect of the combined treatment of lenalidomide and rituximab in controlling the Follicular Lymphoma disease and also increase the length of response compared to the available standard combination chemotherapy treatment for Follicular Lymphoma.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Celgene; Celgene Corporation
• Collaborator: The Lymphoma Academic Research Organisation
• Treatments: Bendamustine Hydrochloride; Lenalidomide; Rituximab; Thalidomide

Criteria

Inclusion Criteria:

• Histologically confirmed follicular lymphoma grade 1, 2 or 3a, Stage II-IV

• Have no prior systemic treatment for lymphoma

• Symptomatic follicular lymphoma requiring treatment.

• Age ≥18 years

• Eastern Cooperative oncology group performance status 0-2

• Willing to follow pregnancy precautions

Exclusion Criteria:

• Clinical evidence of transformed lymphoma or Grade 3b follicular lymphoma.

• Major surgery (excluding lymph node biopsy) within 28 days prior to signing informed consent.

• Known seropositive for or active viral infection with hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV)

• Known sensitivity or allergy to murine products.

• Presence or history of central nervous system involvement by lymphoma

• At high risk for a venous thromboembolic event (VTE) and not willing to take VTE prophylaxis

• Any of the following laboratory abnormalities:

• serum aspartate transaminase or alanine transaminase > 3x upper limit of normal (ULN), except in patients with documented liver involvement by lymphoma

• total bilirubin > 2.0 mg/dl (34 µmol/L) except in cases of Gilberts Syndrome and documented liver or pancreatic involvement by lymphoma

• creatinine clearance of < 30 mL/min