A Study to Evaluate the Efficacy of Lenalidomide as Maintenance Therapy After Completion of First-line Combination Chemotherapy in Patients With Mantle Cell Lymphoma (MCL).
Stopped early · Phase 3 · Has a placebo group
Conditions studied: Mantle Cell Lymphoma, Non-Hodgkin's Lymphoma
In brief
A study to evaluate the efficacy of lenalidomide as maintenance therapy after completion of first-line combination chemotherapy in patients with mantle cell lymphoma (MCL) who are not candidates for transplantation and have achieved partial response (PR) or complete response (CR). This study was prematurely terminated by the sponsor in light of new unpublished data that rendered the current design of the study no longer clinically relevant. A study design with the control arm of no active treatment was no longer appropriate. The termination of the trial was not based on any safety concerns in the study.
Key facts
- Study ID
- NCT01021423
- Run by
- Celgene
- People needed
- 9
- Starts
- 2010-04-01
- Expected to finish
- 2011-03-01
- Last updated by the study team
- 2019-11-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Histologically-proven mantle cell non-Hodgkin's lymphoma,
- One of the following first-line induction chemotherapy regimens with rituximab: (1) combination regimen containing all of the following components: cyclophosphamide, vincristine, adriamycin and a glucocorticoid; (2) Fludarabine containing regimen such as FC (fludarabine, cyclophosphamide)
- Achieved a PR or better response after the first-line induction chemotherapy regimen (assessed by 2007 Revised Response Criteria for Malignant Lymphoma)
- ECOG performance status score of ≤ 2
- Willing to follow pregnancy precaution
You may not qualify if…
- Patients who have received more than 1 line of induction chemotherapy;
- Patients who have received less than 4 cycles of R-CHOP, R-CHOP-like, or R-FC are ineligible;
- Patients who achieved stable disease or progressive disease as best response with first line-induction chemotherapy;
- Any of the following laboratory abnormalities:
- Absolute neutrophil count (ANC) < 1,500 cells/mm3 (1.5*10\^9/L)
- Platelet count < 60,000/mm\^3 (60*10\^9/L)
- Serum aspartate transaminase (AST/SGOT) or alanine transaminase (ALT/SGPT)) > 3.0 times upper limit of normal (ULN), except in patients with documented liver involvement by lymphoma
- Serum bilirubin > 1.5 times ULN, except in case of Gilbert's Syndrome and documented liver involvement by lymphoma
- Calculated creatinine clearance (i.e. Cockcroft-Gault formula) of < 30 mL /min
- Active or any history of central nervous system (CNS) lymphoma or leptomeningeal involvement by lymphoma
- Subjects at high risk for deep vein thrombosis (DVT) not willing to take DVT prophylaxis
- Known seropositive for or active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV)
Where it is running
- Rocky Mountain Cancer Center — Denver, Colorado, United States
- Rush University Medical Center — Chicago, Illinois, United States
- Indiana University Melvin and Bren Simon Cancer Center — Indianapolis, Indiana, United States
- Providence Cancer Center — Indianapolis, Indiana, United States
- Nebraska Hematology-Oncology, PC — Lincoln, Nebraska, United States
- Hackensack University Medical Center — Hackensack, New Jersey, United States
- Arena Oncology Associates — Lake Success, New York, United States
- Weill Cornell Medical College/New York Presbyterian Hospital — New York, New York, United States
- SUNY Upstate Medical University — Syracuse, New York, United States
- Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
- Avera Cancer Institute — Sioux Falls, South Dakota, United States
- University of Virginia Health Systems — Charlottesville, Virginia, United States
- Fakultni nemocnice Hradec Králové II. Interni klinika-Oddeleni klinicke hematologie — Hradec Králové, Czechia
- Fakultni Nemocnice Olomouc, Hemato-Onkologicka Klinika — Olomouc, Czechia
- Fakultni Nemocnice Kralovske Vinohrady — Prague, Czechia
- Vseobecna Fakultni Nemocnice — Prague, Czechia
- Clinic of Oncology Faculty Hospital Motol — Prague, Czechia
- CHU Amiens Sud, Centre de Recherche Clinique - Pharmacologie Clinique — Amiens, France
- CHU Hôpital Hotel Dieu — Angers, France
- CHU ESTAING, Service d'Hématologie — Clermont-Ferrand, France
- Hôpital Henri Mondor Unité Hémopathies Lymphoides — Créteil, France
- CHD Les Oudairies, Service d'Oncologie Hématologie — La Roche-sur-Yon, France
- Centre Hospitalier Lyon Sud, Pavillon Marcel Bérard 1F Hématologie — La Tronche, France
- CHRU - Hôpital Claude Huriez — Lille, France
- Sharp Healthcare Oncology Associates of San Diego — San Diego, California, United States
Full record on ClinicalTrials.gov
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