A Study to Determine the Efficacy of Lenalidomide Versus Investigator's Choice in Patients With Relapsed or Refractory Mantle Cell Lymphoma (MCL) - Full Text View

Purpose

To evaluate the safety and efficacy of lenalidomide versus investigator choice in patients with relapsed or refractory Mantle Cell Lymphoma.

Condition	Intervention	Phase
Mantle Cell Lymphoma Lymphoma, Mantle-Cell	Drug: Lenalidomide Drug: Investigators choice single agent	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase 2, Multicenter, Randomized Open-Label Study to Determine the Efficacy of Lenalidomide (Revlimid®) Versus Investigator's Choice in Patients With Relapsed or Refractory Mantle Cell Lymphoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lymphoma

Drug Information available for: Cytarabine Chlorambucil Fludarabine Fludarabine phosphate Gemcitabine Gemcitabine hydrochloride Rituximab Lenalidomide

U.S. FDA Resources

Further study details as provided by Celgene Corporation:

Primary Outcome Measures:

Progression free survival (PFS) [ Time Frame: Ongoing ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall response rate [ Time Frame: Ongoing ] [ Designated as safety issue: No ]
Duration of response [ Time Frame: Ongoing ] [ Designated as safety issue: No ]
Tumor control rate [ Time Frame: Ongoing ] [ Designated as safety issue: No ]
Time to progression [ Time Frame: Ongoing ] [ Designated as safety issue: No ]
Time to treatment failure [ Time Frame: Ongoing ] [ Designated as safety issue: No ]
Time to tumor response [ Time Frame: Ongoing ] [ Designated as safety issue: No ]
Overall survival [ Time Frame: Ongoing ] [ Designated as safety issue: No ]
Safety [ Time Frame: Ongoing ] [ Designated as safety issue: Yes ]
Quality of Life [ Time Frame: Ongoing ] [ Designated as safety issue: No ]

Enrollment:	254
Study Start Date:	April 2009
Estimated Study Completion Date:	July 2017
Estimated Primary Completion Date:	May 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Lenalidomide Lenalidomide	Drug: Lenalidomide For patients with a creatinine clearance of ≥60 mL/min: 25mg daily x 21 days of a 28 day cycle until disease progression or unacceptable toxicity. For patients who have a moderate renal insufficiency (creatinine clearance is ≥30 mL/min but <60mL/min: 10mg daily x 21 days of a 28 day cycle (Cycles 1 and 2). After Cycle 2, if the patient remains free of Grade 3 or Grade 4 toxicity, the dose will be increased to 15mg daily x 21 days of a 28 day cycle until disease progression or unacceptable toxicity. Other Names: Revlimid Rev CC-5013
Active Comparator: Investigators choice single agent Investigators choice single agent - Chlorambucil, Rituximab, Cytarabine, Gemcitabine, Fludarabine	Drug: Investigators choice single agent Investigators choice single agent - Chlorambucil, Rituximab, Cytarabine, Gemcitabine, or Fludarabine Other Names: Leukeran Ritux Rituxan cytosine arabinoside Ara-C Cytosar-U Gemzar fludarabine phosphate Fludara

Arms

Assigned Interventions

Experimental: Lenalidomide

Lenalidomide

Drug: Lenalidomide

For patients with a creatinine clearance of ≥60 mL/min: 25mg daily x 21 days of a 28 day cycle until disease progression or unacceptable toxicity.

For patients who have a moderate renal insufficiency (creatinine clearance is ≥30 mL/min but <60mL/min: 10mg daily x 21 days of a 28 day cycle (Cycles 1 and 2). After Cycle 2, if the patient remains free of Grade 3 or Grade 4 toxicity, the dose will be increased to 15mg daily x 21 days of a 28 day cycle until disease progression or unacceptable toxicity.

Other Names:

Revlimid
Rev
CC-5013

Active Comparator: Investigators choice single agent

Investigators choice single agent - Chlorambucil, Rituximab, Cytarabine, Gemcitabine, Fludarabine

Drug: Investigators choice single agent

Investigators choice single agent - Chlorambucil, Rituximab, Cytarabine, Gemcitabine, or Fludarabine

Other Names:

Leukeran
Ritux
Rituxan
cytosine arabinoside
Ara-C
Cytosar-U
Gemzar
fludarabine phosphate
Fludara

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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 Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00875667

Show 100 Study Locations

Sponsors and Collaborators

Celgene Corporation

Investigators

Principal Investigator:

Marek Trneny, MD/PhD/Prof

Head, Ist Dept Medicine, Charles University Hospital; Director, Institute of Hematology and Blood Transfusion; Chair, Czech Lymphoma Study Group

More Information

No publications provided

Responsible Party:	Celgene Corporation
ClinicalTrials.gov Identifier:	NCT00875667 History of Changes
Other Study ID Numbers:	CC-5013-MCL-002
Study First Received:	April 1, 2009
Last Updated:	March 11, 2013
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency Germany: Federal Institute for Drugs and Medical Devices France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Denmark: Danish Medicines Agency Greece: National Organization of Medicines Sweden: Medical Products Agency Czech Republic: State Institute for Drug Control Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Spain: Spanish Agency of Medicines Belgium: Federal Agency for Medicinal Products and Health Products Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) Russia: Ministry of Health of the Russian Federation Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Celgene Corporation:

Mantle Cell Lymphoma
Relapsed Mantle Cell Lymphoma
Refractory Mantle Cell Lymphoma
Lymphoma
MCL

Additional relevant MeSH terms:

Lymphoma
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Cytarabine
Fludarabine monophosphate
Thalidomide
Fludarabine
Lenalidomide
Antimetabolites, Antineoplastic

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Leprostatic Agents
Anti-Bacterial Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances

ClinicalTrials.gov processed this record on May 23, 2013

A Study to Determine the Efficacy of Lenalidomide Versus Investigator's Choice in Patients With Relapsed or Refractory Mantle Cell Lymphoma (MCL) (Sprint)