Status:
COMPLETED
A Study to Determine the Efficacy and Safety of Lenalidomide in Patients With Mantle Cell NHL Who Have Relapsed or Progressed After Treatment With Bortezomib or Are Refractory to Bortezomib. The "EMERGE" Trial
Lead Sponsor:
Celgene
Conditions:
Mantle Cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
To evaluate the safety and efficacy of Lenalidomide (Revlimid (R)) in subjects with mantle cell lymphoma who have relapsed, progressed or are refractory to bortezomib.
Detailed Description
Follow up phase will continue until either 100% of the patients have died, are lost to follow up or have withdrawn consent or a maximum of 4 years from the last patient enrolled, whichever comes first...
Eligibility Criteria
Inclusion
- Biopsy proven mantle cell lymphoma
- Patients must have documents relapsed, refractory or PD after treatment with bortezomib
- Must have measureable disease on cross sectional imaging by CT
- Eastern Cooperative Oncology Group (ECOG) performance score 0,1 or 2
- Willing to follow pregnancy precautions
Exclusion
- Any of the following laboratory abnormalities
- Absolute neutrophil count (ANC) \< 1,500 cells/mm3 (1.5 x 109/L)
- Platelet count \< 60,000/mm3 (60 x 109/L)
- Serum aspartate transaminase/Serum glutamic oxaloacetic transaminase(AST/SGOT) or alanine transaminase/Serum glutamic pyruvic transaminase (ALT/SGPT) \> 3.0 x upper limit of normal (ULN), except in patients with documented liver involvement by lymphoma.
- Serum total bilirubin \> 1.5 x ULN, except in cases of Gilbert's Syndrome and documented liver involvement by lymphoma.
- Calculated creatinine clearance (Cockcroft-Gault formula) of \< 30 mL /min
- Patients who are candidates for high dose chemotherapy/allogeneic stem cell transplant are not eligible
- History of active central nervous system (CNS) lymphoma within the previous 3 months
- Subjects not willing or unable to take deep vein thrombosis (DVT) prophylaxis
- Prior history of malignancies, other than MCL, unless the patient has been free of the disease for ≥ 3 years
- Positive Human immunodeficiency virus (HIV) or active Hepatitis B or C
Key Trial Info
Start Date :
December 22 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 8 2017
Estimated Enrollment :
134 Patients enrolled
Trial Details
Trial ID
NCT00737529
Start Date
December 22 2008
End Date
November 8 2017
Last Update
December 13 2018
Active Locations (70)
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1
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
2
UCSD Moores Cancer Center
La Jolla, California, United States, 92093
3
Loma Linda University Medical Center
Loma Linda, California, United States, 92354
4
Tower Cancer Research Foundation
Los Angeles, California, United States, 90211