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A Phase 3 Multicenter, Randomized, Double-blind, Placebo-Controlled, First Line Maintenance Study Of Lenalidomide (Revlimid®) In Patients With Mantle-Cell Lymphoma


Phase 3
18 Years
N/A
Not Enrolling
Both
Mantle Cell Lymphoma, Non-Hodgkin's Lymphoma

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Trial Information

A Phase 3 Multicenter, Randomized, Double-blind, Placebo-Controlled, First Line Maintenance Study Of Lenalidomide (Revlimid®) In Patients With Mantle-Cell Lymphoma


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)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Progression-free Survival (PFS)

Outcome Description:

PFS is defined as the time from randomization into the study to the first observation of disease progression or death due to any cause. Progression, as defined by the 2007 Revised Response Criteria for Malignant Lymphoma (Cheson, 2007), is any new lesion or increase by 50% of previously involved sites from nadir. Study terminated prematurely. Analysis not conducted.

Outcome Time Frame:

up to 7 years

Safety Issue:

No

Principal Investigator

Martin Dreyling, Prof. Dr

Investigator Role:

Principal Investigator

Investigator Affiliation:

Medizinische Klinik III der Universität München

Authority:

United States: Food and Drug Administration

Study ID:

CC-5013-MCL-003

NCT ID:

NCT01021423

Start Date:

April 2010

Completion Date:

March 2011

Related Keywords:

  • Mantle Cell Lymphoma
  • Non-Hodgkin's Lymphoma
  • Mantle Cell Lymphoma
  • Non-Hodgkin's Lymphoma
  • CC-5013
  • Revlimid
  • Lenalidomide
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, Mantle-Cell

Name

Location

Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Avera Cancer InstituteSioux Falls, South Dakota  57105
Rush University Medical CenterChicago, Illinois  60612-3824
Hackensack University Medical CenterHackensack, New Jersey  07601
Rocky Mountain Cancer CenterDenver, Colorado  80218
Indiana University Melvin and Bren Simon Cancer CenterIndianapolis, Indiana  46202-5289
Arena Oncology AssociatesGreat Neck, New York  11021
SUNY Upstate Medical UniversitySyracuse, New York  13210
Nebraska Hematology-Oncology, PCLincoln, Nebraska  68506
University of Virginia Health SystemsCharlottesville, Virginia  22908-0386
Sharp Healthcare Oncology Associates of San DiegoSan Diego, California  92123
Providence Cancer CenterIndianapolis, Indiana  97213
Weill Cornell Medical College/New York Presbyterian HospitalNew York, New York  10021