A Study to Evaluate Lenalidomide Combined With Dexamethasone in Relapsed or Refractory Diffuse Large B-Cell Lymphoma

NCT00474188 | Terminated Phase 2 Results DMC

• 1 other identifier: CC-5013-NHL-005
• Study Type: interventional
• Target: 26
• Locations: 3 countries
• Sites: 24

Brief Summary

To evaluate the safety and efficacy of lenalidomide (Revlimid ®) in combination with dexamethasone in subjects with relapsed or refractory diffuse large B-cell lymphoma.

Conditions

Diffuse Large B-cell Lymphoma

Keywords

Celgene; Revlimid; Lenalidomide; Diffuse Large B-cell lymphoma; Non-Hodgkins lymphoma; CC-5013; Response Rate; Tumor Control Rate; Duration of Response; Time to Progression; Progression-free survival and safety

Outcome Measures

Primary Outcomes (1)

• Tumor Response Rate

  Number of participants demonstrating complete or partial tumor response (Cheson B, Horning S, Coiffier B, Shipp M, Fisher R, Connors J, et al, Report of an international workshop to standardize response criteria for non-Hodgkins' lymphoma. J Clin Oncol.1999;17:1244-53). Study terminated prematurely. Analysis not conducted.

  One Year

Secondary Outcomes (4)

• Tumor Control Rate

  One Year

• Duration of Response

  One year

• Time to Progression

  One year

• Progression-free Survival

  One year

Study Arms (1)

Single Arm

EXPERIMENTAL

Drug: CC-5013 (lenalidomide); Drug: dexamethasone

Interventions

CC-5013 (lenalidomide) DRUG

Lenalidomide 25 mg, orally, once daily, on Days 1 to 21 of every 28-day cycle administerd in combination with dexamethasone 40 mg, orally, once daily, on Days 1, 8, 15, and 22 of every 28-day cycle

Also known as: CC-5013, lenalidomide, Revlimid

Single Arm

dexamethasone DRUG

Dexamethasone 40 mg, orally, once daily, on Days 1, 8, 15, and 22 of every 28-day cycle administered in combination with lenalidomide 25 mg, orally, once daily, on Days 1 to 21 of every 28-day cycle.

Also known as: Decadron

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Biopsy-proven diffuse large B-cell non-Hodgkin's lymphoma
• Relapsed or refractory to previous therapy for non-Hodgkin's lymphoma
• Measurable disease on cross sectional imaging that is at least 2 cm in the longest diameter
• ECOG performance score of 0,1 or 2
• Willing to follow the pregnancy precautions

You may not qualify if:

• 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 SGOT/AST or SGPT/ALT 5.0 x upper limit of normal (ULN).
• Serum total bilirubin \> 2.0 mg/dL (34 µmol/L).
• Subjects who are candidates for and willing to undergo an autologous stem cell transplant.
• History of active CNS lymphoma within the previous 3 months
• Subjects not willing or unable to take DVT prophylaxis
• History of other malignancies within the past year
• Positive HIV or active Hepatitis B or C

Sponsors & Collaborators

• Celgene Corporation: lead

Study Sites (24)

Palo Verde Hematology/Oncology, Ltd.

Glendale, Arizona, 85304, United States

Location

Tower Cancer Research Foundation

Beverly Hills, California, 90211, United States

Location

Advanced Medical Specialties

Miami, Florida, 33176, United States

Location

Hematology/Oncology Associates of Treasure Coast

Port Saint Lucie, Florida, 34952, United States

Location

Northwest Georgia Oncology Centers

Marietta, Georgia, 30060, United States

Location

Cancer Care & Hematology Specialists of Chicagoland

Arlington Heights, Illinois, 60005, United States

Location

Northwestern University, Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Southwest Oncology Associates

Lafayette, Louisiana, 70503, United States

Location

Washington County Hospital, The Center for Clinical Research

Hagerstown, Maryland, 21742, United States

Location

Kalamazoo Hematology & Oncology

Kalamazoo, Michigan, 49048, United States

Location

Oncology & Hematology Specialists, PA

Denville, New Jersey, 07834, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Northwestern Carolina, Oncology and Hematology PA

Hickory, North Carolina, 28602, United States

Location

New Bern Cancer Care

New Bern, North Carolina, 28562, United States

Location

James Cancer Hospital

Columbus, Ohio, 43210, United States

Location

SouthWest Regional Cancer Center

Austin, Texas, 78705, United States

Location

Northern Utah Associates

Ogden, Utah, 84403, United States

Location

The Alfred Hospital

Melbourne, Victoria, VIC3050, Australia

Location

Frankston Hospital

Frankston, VIC 3199, Australia

Location

HOCA

South Brisbane, QLD 4101, Australia

Location

Border Medical Oncology

Wodonga, VIC 3690, Australia

Location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse; Lymphoma, Non-Hodgkin

Interventions

Lenalidomide; Dexamethasone; Calcium Dobesilate

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Limitations and Caveats

Study terminated prematurely as a business decision. Analyses of efficacy not conducted.

Results Point of Contact

• Title: Robert Kinght, M.D.
• Organization: Celgene Corporation

rknight@celgene.com

908-673-9749

Study Officials

• Andrew Spencer, MD

  The Alfred

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 14, 2007
• First Posted: May 16, 2007
• Study Start: May 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: September 2, 2009
• Results First Posted: August 13, 2009

Record last verified: 2009-08

Locations

CA (1); AU (4); US (19)