Status:
COMPLETED
A Study of Revlimid in the Treatment of Non-Hodgkin's Lymphoma
Lead Sponsor:
Celgene
Conditions:
Lymphoma, Non-Hodgkin's
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Subjects who qualify will receive oral lenalidomide daily on days 1-21 of every 28 day cycle. Treatment will continue until disease progression, or unacceptable adverse events develop
Eligibility Criteria
Inclusion
- Key Inclusion criteria
- Biopsy proven aggressive non-hodgkin's lymphoma
- Follicular center lymphoma Grade 3.
- Diffuse large B-cell lymphoma.
- Mantle cell lymphoma.
- Transformed lymphoma.
- Relapsed or refractory to previous therapy for lymphoma
- At least one prior combination chemotherapy regime
- Measurable disease on cross sectional imaging that is at least 2 cm in the longest diameter
- Eastern Cooperative Oncology Group (ECOG) performance score of 0, 1 or 2
- Willing to follow the pregnancy precautions
- Key Exclusion criteria
- Any of the following laboratory abnormalities.
- Absolute neutrophil count (ANC) \< 1,500 cells/mm\^3 (1.5\*10\^9/L).
- Platelet count \< 60,000/mm\^3 (60\*10\^9/L).
- Calculated creatinine clearance of \<50mL/min
- Serum glutamic oxaloacetic transaminase/aspartate aminotransferase (SGOT/AST) or Serum glutamic pyruvic transaminase/Alanine transaminase (SGPT/ALT) 5.0 times upper limit of normal (ULN).
- Serum total bilirubin \> 2.0 mg/dL (34 µmol/L)/conjugated bilirubin \>0.8mg/dL.
- Subjects who are candidates for and willing to undergo an autologous stem cell transplant.
- History of active Central Nervous System (CNS) lymphoma within the previous 6 months
- History of other malignancies within the past year
- Positive Human immunodeficiency virus (HIV) or active Hepatitis B or C
Exclusion
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
217 Patients enrolled
Trial Details
Trial ID
NCT00413036
Start Date
June 1 2006
End Date
May 1 2011
Last Update
March 1 2017
Active Locations (53)
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1
Northwest Alabama Cancer Center, PC
Muscle Shoals, Alabama, United States, 35661
2
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259
3
Lalita Pandit, MD, Inc
Fountain Valley, California, United States, 92708
4
Access Clinical Research
Rancho Mirage, California, United States, 92270