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

Completed · Phase 2

Conditions studied: Mantle Cell Lymphoma

In brief

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.

Key facts

Study ID

NCT00737529

Run by

Celgene

People needed

134

Starts

2008-12-22

Expected to finish

2017-11-08

Last updated by the study team

2018-12-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UCSD Moores Cancer Center — La Jolla, California, United States
• Loma Linda University Medical Center — Loma Linda, California, United States
• Tower Cancer Research Foundation — Los Angeles, California, United States
• Boca Raton Community Hospital, Inc., Research Dept. — Boca Raton, Florida, United States
• Pasco Hernando Oncology Associates, PA — Brooksville, Florida, United States
• Broward General Medical Center — Fort Lauderdale, Florida, United States
• MD Anderson Cancer Center, Orlando Regional Healthcare — Orlando, Florida, United States
• Lake County Oncology and Hematology — The Villages, Florida, United States
• Winship Cancer Institute of Emory University — Atlanta, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• Loyola University Medical Center - Smith — Maywood, Illinois, United States
• Indiana University Cancer Center — Indianapolis, Indiana, United States
• Alvin and Lois Lapidus Cancer Institute Sinai Hospital of Baltimore — Baltimore, Maryland, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• University of Massachusetts Medical Center — Worcester, Massachusetts, United States
• Karmanos Cancer Institute — Detroit, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Washington University Siteman Cancer Center — St Louis, Missouri, United States
• University of Nebraska — Omaha, Nebraska, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States
• NYU School of Medicine — New York, New York, United States
• University of Rochester Cancer Center, James P. Wilmot Cancer Center — Rochester, New York, United States
• Presbyterian Hospital — Charlotte, North Carolina, United States
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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