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 - Full Text View

Purpose

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.

Condition	Intervention	Phase
Mantle Cell Lymphoma	Drug: lenalidomide	Phase 2

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase 2, Multicenter, Single-Arm, Open-Label Study to Determine the Efficacy and Safety of Single-Agent Lenalidomide (Revlimid (R)) in Patients With Mantle Cell NHL Who Have Relapsed or Progressed After Treatment With Bortezomib or Are Refractory to Bortezomib. The "EMERGE" Trial

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lymphoma

Drug Information available for: Bortezomib Lenalidomide

U.S. FDA Resources

Further study details as provided by Celgene Corporation:

Primary Outcome Measures:

Tumor Response and Duration of Response(Radiological Assessments as defined by IWLRC 1999) [ Time Frame: After all subjects complete 6 cycles of study drug ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Evaluate Safety of lenalidomide [ Time Frame: throughout study until 28 days post last dose of study drug ] [ Designated as safety issue: Yes ]
Time to Progression [ Time Frame: 70% of the patients have died or a maximum of 4 years from last patient enrolled, which ever comes first ] [ Designated as safety issue: No ]
• 70% of the patients have died or a maximum of 4 years from last patient enrolled, which ever comes first
Overall Survival [ Time Frame: 70% of the patients have died or a maximum of 4 years from last patient enrolled, which ever comes first ] [ Designated as safety issue: No ]
• 70% of the patients have died or a maximum of 4 years from last patient enrolled, which ever comes first

Enrollment:	134
Study Start Date:	October 2008
Estimated Study Completion Date:	February 2014
Primary Completion Date:	July 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Lenalidomide Single agent Lenalidomide	Drug: lenalidomide 25mg oral capsules continuous days 1-21 each of a 28 day cycle Other Name: Revlimid

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 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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00737529

Show 71 Study Locations

Sponsors and Collaborators

Celgene Corporation

Investigators

Study Director:

Lei Zhang, MD

Celgene Corporation

More Information

No publications provided

Responsible Party:	Celgene Corporation
ClinicalTrials.gov Identifier:	NCT00737529 History of Changes
Other Study ID Numbers:	CC-5013-MCL-001
Study First Received:	August 15, 2008
Last Updated:	March 19, 2013
Health Authority:	United States: Food and Drug Administration Singapore: Health Sciences Authority Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos Austria: Agency for Health and Food Safety Belgium: Federal Agency for Medicinal Products and Health Products France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Federal Institute for Drugs and Medical Devices Hungary: National Institute of Pharmacy Israel: Ministry of Health Italy: The Italian Medicines Agency Spain: Comité Ético de Investigación Clínica Turkey: Ministry of Health

Keywords provided by Celgene Corporation:

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

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
Bortezomib
Lenalidomide
Thalidomide
Antineoplastic Agents
Therapeutic Uses

Pharmacologic Actions
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors

ClinicalTrials.gov processed this record on June 17, 2013