Status:
COMPLETED
A Study to Determine the Efficacy of Lenalidomide Versus Investigator's Choice in Patients With Relapsed or Refractory Mantle Cell Lymphoma (MCL)
Lead Sponsor:
Celgene
Conditions:
Mantle Cell Lymphoma
Lymphoma, Mantle-Cell
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
To evaluate the safety and efficacy of lenalidomide versus investigator choice in patients with relapsed or refractory mantle cell lymphoma.
Detailed Description
This research study is for patients who have relapsed or refractory mantle cell lymphoma following treatment such as radiotherapy, immunotherapy, chemotherapy, or radioimmunotherapy. Chemotherapy agen...
Eligibility Criteria
Inclusion
- Biopsy proven mantle cell lymphoma
- Patients who are refractory to their regimen or have relapsed once, twice or up to three times and who have documented progressive disease
- Eastern Cooperative Oncology Group (ECOG) performance score 0,1, or 2
- Willing to follow pregnancy precaution
Exclusion
- Any of the following laboratory abnormalities
- Absolute neutrophil count (ANC) \< 1,500 cells/mm\^3 (1.5 x 10\^9/L)
- Platelet count \< 60,000/mm\^3 (60 x 10\^9/L)
- Serum aspartate transaminase/serum glutamic oxaloacetic transaminase(AST/SGOT) or alanine transaminase/serum glutamic pyruvic transaminase (ALT/SGPT) \>3.0 x upper limit or normal (ULN), except patients with documented liver involvement by lymphoma
- Serum total bilirubin \> 1.5 x ULN, except in case of Gilbert's Syndrome and documented liver involvement by lymphoma.
- Calculated creatinine clearance (Cockcroft-Gault formula) of \< 30 mL/min
- History of active central nervous system (CNS) lymphoma within the previous 3 months
- Subjects not willing to take deep venous thrombosis (DVT) prophylaxis
- Known seropositive for or active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV). Patients who are sero-positive because of hepatitis B virus vaccine are eligible
Key Trial Info
Start Date :
April 30 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 9 2018
Estimated Enrollment :
254 Patients enrolled
Trial Details
Trial ID
NCT00875667
Start Date
April 30 2009
End Date
October 9 2018
Last Update
September 16 2019
Active Locations (97)
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1
UZ Brussels
Brussels, Belgium, 1090
2
UZ Gent
Ghent, Belgium, 9000
3
AZ Groeninge
Kortrijk, Belgium, 8500
4
Cliniques Universitaires UCL de Mont-Godine
Yvoir, Belgium, 5530