Combined Rituximab and Lenalidomide Treatment for Untreated Patients With Follicular Lymphoma
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Lymphoma |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/17/2018 |
| Start Date: | December 29, 2011 |
| End Date: | June 1, 2024 |
A Phase 3 Open-Label Randomized Study to Compare the Efficacy and Safety of Rituximab Plus Lenalidomide (CC-5013) Versus Rituximab Plus Chemotherapy in Subjects With Previously Untreated Follicular Lymphoma
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.
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.
Follicular Lymphoma (FL) is a cancer of a B lymphocyte, a type of white blood cell. FL is
typically a slowly progressing but incurable disease. Follicular lymphoma cells produce a
specific defect in the patient's immune system impairing their ability to control their
cancer. Lenalidomide has been shown to reverse the specific immune defect caused by FL in the
patient. By including lenalidomide, the RELEVANCE study aims to eliminate the cancer while
restoring the patient's immune competence.
The 'Relevance' cooperative group trial is being conducted as two companion studies:
RV-FOL-GELARC-0683 (N=750) and RV-FOL-GELARC-0683C (N=250); the combined total of 1000
Follicular Lymphoma patients enrolled in both studies will be analyzed.
typically a slowly progressing but incurable disease. Follicular lymphoma cells produce a
specific defect in the patient's immune system impairing their ability to control their
cancer. Lenalidomide has been shown to reverse the specific immune defect caused by FL in the
patient. By including lenalidomide, the RELEVANCE study aims to eliminate the cancer while
restoring the patient's immune competence.
The 'Relevance' cooperative group trial is being conducted as two companion studies:
RV-FOL-GELARC-0683 (N=750) and RV-FOL-GELARC-0683C (N=250); the combined total of 1000
Follicular Lymphoma patients enrolled in both studies will be analyzed.
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
We found this trial at
37
sites
660 S Euclid Ave
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Holy Cross Hospital While spirituality plays an essential role in the way that we minister...
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Seattle Cancer Care Alliance Seattle Cancer Care Alliance (SCCA) is a cancer treatment center that...
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Roger Maris Cancer Center Sanford Health is an integrated health system headquartered in the Dakotas...
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University of Kentucky The University of Kentucky is a public, land grant university dedicated to...
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Sarah Cannon Cancer Center People who live with cancer
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Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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