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Complete title: A Phase 3 Open-Label Randomized Study to Compare the Efficacy and Safety of Rituximab Plus Lenalidomide (CC-5013) Versus Rituximab Plus chemotherapy Followed by Rituximab in subjects with Previously Untreated Follicular Lymphoma (The RELEVANCE Trial)
|Research Study Number||7636|
|Principal Investigator||Edward Libby|
Research Study Description
Eligibility Criteria (must meet the following to participate in this study)
- Genders Eligible for Study: Both
- 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
Other eligibility criteria may apply.
Exclusions (conditions that would prevent participation in this study)
- 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
Other exclusion criteria may apply.
Hematologic Malignancies; Lymphoma
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