Status:
COMPLETED
Rituximab and/or Lenalidomide in Treating Patients With Follicular Non-Hodgkin's Lymphoma That is Not Refractory to Rituximab
Lead Sponsor:
Alliance for Clinical Trials in Oncology
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry can...
Detailed Description
Outline: This is a randomized, multicenter study. Patients are randomized to 1 of 3 treatment arms. Please see the "Arms" section for a description of each treatment arm. The primary and secondary ob...
Eligibility Criteria
Inclusion
- Documentation of Disease
- Previously treated, histologically confirmed follicle center cell lymphoma, World Health Organization (WHO) classification, grade 1, 2, or 3a
- Institutional flow cytometry or immunohistochemistry must confirm Cluster of Differentiation 20 (CD20) antigen expression.
- Prior Treatment
- Patient must have been treated with rituximab either alone or in combination with chemotherapy.
- Patient must have a time to progression of ≥ 6 months from last rituximab dose.
- No corticosteroids within two weeks prior to study, except for maintenance therapy for a non-malignant disease. Maintenance therapy dose may not exceed 20 mg/day prednisone or equivalent.
- No prior radioimmunotherapy within 12 months of study entry.
- Age ≥ 18 years.
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2.
- Measurable disease must be present either on physical examination or imaging studies. Non-measurable disease alone is not acceptable. Any tumor mass \>1 cm is acceptable.Lesions that are considered non-measurable include the following:
- Bone lesions
- Ascites
- Pleural/pericardial effusion
- Lymphangitis cutis/pulmonis
- Bone marrow
- No known Central Nervous System (CNS) involvement by lymphoma.
- No known Human Immunodeficiency Virus (HIV) infection.
- Non-pregnant and non-nursing.
- Patients with a "currently active" second malignancy, other than non-melanoma skin cancers, are not eligible.
- Patients with a recent history (within 3 months of study entry) of Deep Vein Thrombosis/Pulmonary Embolism (DVT/PE) are not eligible.
- Required Initial Laboratory Values:
- Absolute Neutrophil Count (ANC) ≥ 1000/µL
- Platelet count ≥ 75,000/µL
- Creatinine \< 1.5 x Upper Limit of Normal (ULN) unless attributed to lymphoma or calculated clearance \> 50 mL/min (patients on dialysis are not eligible)
- Total Bilirubin ≤ 2 x ULN unless attributed to lymphoma or Gilbert's disease
Exclusion
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
97 Patients enrolled
Trial Details
Trial ID
NCT00238238
Start Date
March 1 2006
End Date
August 1 2015
Last Update
March 15 2017
Active Locations (79)
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1
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, United States, 92093-0658
2
Kaiser Permanente Medical Office -Vandever Medical Office
San Diego, California, United States, 92120
3
Walter Reed Army Medical Center
Washington D.C., District of Columbia, United States, 20307-5001
4
Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
Fort Lauderdale, Florida, United States, 33308