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

Sponsored by:	Celgene Corporation
Information provided by:	Celgene Corporation
ClinicalTrials.gov Identifier:	NCT00474188

Purpose

To evaluate the safety and efficacy of Lenalidomide (Revlimid ®) in combination with Dexamethasone in subject with relapsed or refractory diffuse large B-cell lymphoma

Condition	Intervention	Phase
B-Cell Lymphoma	Drug: CC-5013 (lenalidomide)	Phase II

MedlinePlus related topics: Cancer Lymphoma

Drug Information available for: Dexamethasone Dexamethasone acetate Dexamethasone Sodium Phosphate Doxiproct plus Lenalidomide CC 5013

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase II, Multi-Center, Single-Arm, Open-Label Study to Evaluate the Safety and Efficacy of Lenalidomide (Revlimid ®) in Combination With Dexamethasone in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Further study details as provided by Celgene Corporation:

Primary Outcome Measures:

Response Rate [ Time Frame: One Year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Tumor Control Rate, Duration of Response [ Time Frame: One Year ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	40
Study Start Date:	May 2007
Estimated Study Completion Date:	June 2008
Estimated Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Single Arm	Drug: CC-5013 (lenalidomide) Lenalidomide combined with Dexamethasone

Eligibility

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

Criteria

Inclusion Criteria:

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

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 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00474188

Locations

Australia, Victoria
The Alfred Hospital
Melbourne, Victoria, Australia, VIC3050

Sponsors and Collaborators

Celgene Corporation

Investigators

Principal Investigator:

Andrew Spencer, MD

The Alfred Hospital

More Information

Responsible Party:	Celgene/sponsor ( Debbie Ingenito )
Study ID Numbers:	CC-5013-NHL-005
Study First Received:	May 14, 2007
Last Updated:	November 6, 2008
ClinicalTrials.gov Identifier:	NCT00474188
Health Authority:	United States: Food and Drug Administration

Keywords provided by Celgene Corporation:

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

Study placed in the following topic categories:

Dexamethasone
Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders
Lenalidomide
Disease Progression
Lymphoma, small cleaved-cell, diffuse
Lymphoma, B-Cell

Lymphoma, large-cell
Lymphatic Diseases
B-cell lymphomas
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma
Dexamethasone acetate

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Neoplasms by Histologic Type
Antineoplastic Agents, Hormonal
Immune System Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Gastrointestinal Agents
Antiemetics

Glucocorticoids
Hormones
Pharmacologic Actions
Neoplasms
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009