Non Hodgkin Lymphoma Clinical Trial
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).
Summary
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This study was prematurely terminated by the sponsor in light of new unpublished data that rendered the current design of the study no longer clinically relevant.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.
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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)
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There are 89 Locations for this study
San Diego California, 92123, United States
Denver Colorado, 80218, United States
Chicago Illinois, 60612, United States
Indianapolis Indiana, 46202, United States
Indianapolis Indiana, 97213, United States
Lincoln Nebraska, 68506, United States
Hackensack New Jersey, 07601, United States
Lake Success New York, 11042, United States
New York New York, 10021, United States
Syracuse New York, 13210, United States
Philadelphia Pennsylvania, 19111, United States
Sioux Falls South Dakota, 57105, United States
Charlottesville Virginia, 22908, United States
Hradec Králové , 500 0, Czechia
Olomouc , 77520, Czechia
Prague 5 , , Czechia
Praha 10 , 10034, Czechia
Praha 2 , 12808, Czechia
Amiens Cedex , 80054, France
Angers , 49000, France
Clermont Ferrand Cedex 1 , 63003, France
Créteil , 94010, France
La Roche sur Yon , 85000, France
La Tronche , 38700, France
Lille Cedex , 59037, France
Montpellier cedex 5 , 34295, France
Nantes Cedex 1 , 44093, France
Paris Cedex 10 , 75475, France
Pessac , 33604, France
Pierre Bénite Cedex , 69495, France
Poitiers , 86000, France
Reims Cedex , 51092, France
Rennes Cedex , 35033, France
Rouen Cedex 1 , 76038, France
Toulouse cedex 9 , 31059, France
Tours , 37044, France
Vandoeuvre Les Nancy , 54511, France
Essen , 45122, Germany
Freiburg , 79106, Germany
Göttingen , 37099, Germany
Hamburg , 20099, Germany
Karlsruhe , 76135, Germany
München , 81377, Germany
Tuebingen , 72076, Germany
Beer Sheva , 84101, Israel
Petah Tiqwa , 49100, Israel
Alessandria , 15121, Italy
Bolzano , 39100, Italy
Florence , 50139, Italy
Genova , 16132, Italy
Messina , 98158, Italy
Milano , 20132, Italy
Milan , 20162, Italy
Napoli , 80131, Italy
Novara , 28100, Italy
Pavia , 27100, Italy
Reggio Calabria , 89100, Italy
Roma , 00168, Italy
S.Giovanni Rotondo (FG) , 71013, Italy
Torino , 10126, Italy
Tricase , 73039, Italy
Udine , 33100, Italy
Krakow , 30-51, Poland
Lodz , 93510, Poland
Wroclaw , 53439, Poland
Coimbra , 300-0, Portugal
Lisboa , 1099-, Portugal
Porto , 4200-, Portugal
San Juan , 00918, Puerto Rico
Ekaterinburg , 62010, Russian Federation
Kazan , 42002, Russian Federation
Moscow , 11547, Russian Federation
Perm , 61460, Russian Federation
St. Petersburg , 19102, Russian Federation
St. Petersburg , 19702, Russian Federation
St. Petersburg , 19734, Russian Federation
Volgograd , 40013, Russian Federation
Barcelona , 08035, Spain
Madrid , , Spain
Marbella (Málaga) , 29600, Spain
Ourense , , Spain
Pamplona , 31008, Spain
Salamanca , 37007, Spain
Santander , 39008, Spain
Canterbury, Kent , CT1 3, United Kingdom
County Of Devon , TQ2 7, United Kingdom
Exeter , EX2 5, United Kingdom
Glasgow , G12 O, United Kingdom
London , EC1M , United Kingdom
Plymouth , PL6 8, United Kingdom
Salisbury , SP2 8, United Kingdom
St. Helens , WA9 3, United Kingdom
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