A Study of Revlimid for Treatment of Non-hodgkin's Lymphoma

This study is ongoing, but not recruiting participants.

First Received: December 18, 2006 Last Updated: August 26, 2009 History of Changes

Sponsor:	Celgene Corporation
Information provided by:	Celgene Corporation
ClinicalTrials.gov Identifier:	NCT00413036

Purpose

Subjects who qualify will receive oral lenalidomide daily on days 1-21 of every 28 day cycle. Treatment will continue until disease progression, or unacceptable adverse events develop

Condition	Intervention	Phase
Lymphoma, Non-Hodgkin's	Drug: lenalidomide	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase II, Multicenter, Single-Arm, Open-Label Study To Evaluate The Safety And Efficacy Of Single-Agent Lenalidomide (Revlimid®, CC-5013) In Subjects With Relapsed Or Refractory Aggressive Non-Hodgkin's Lymphoma

Resource links provided by NLM:

MedlinePlus related topics: Lymphoma

Drug Information available for: Lenalidomide CC 5013

U.S. FDA Resources

Further study details as provided by Celgene Corporation:

Primary Outcome Measures:

response rate [ Time Frame: every 2 months from the start of study medication until treatement discontinuation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

reported side effects [ Time Frame: First dose of medication until 30 days after the last dose ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	200
Study Start Date:	June 2006
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
single arm: Experimental	Drug: lenalidomide once daily capsule dosing Drug: lenalidomide once daily capsule

Eligibility

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

Criteria

Key Inclusion criteria

Biopsy proven aggressive non-hodgkin's lymphoma
- Follicular center lymphoma Grade 3.
- Diffuse large B-cell lymphoma.
- Mantle cell lymphoma.
- Transformed lymphoma.
Relapsed or refractory to previous therapy for lymphoma
At least one prior combination chemotherapy regime
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

Key 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).
- Calculated creatinine clearance of <50mL/min
- Serum SGOT/AST or SGPT/ALT 5.0 x upper limit of normal (ULN).
- Serum total bilirubin > 2.0 mg/dL (34 µmol/L)/conjugated bilirubin >0.8mg/dL.
Subjects who are candidates for and willing to undergo an autologous stem cell transplant.
History of active CNS lymphoma within the previous 6 months
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: NCT00413036

Show 24 Study Locations

Sponsors and Collaborators

Celgene Corporation

Investigators

Study Director:

Annette Earvin-Haynes, DO

Celgene Corporation

More Information

No publications provided

Responsible Party:	Celgene Corporation ( Celgene Corporation )
Study ID Numbers:	CC-5013-NHL-003
Study First Received:	December 18, 2006
Last Updated:	August 26, 2009
ClinicalTrials.gov Identifier:	NCT00413036 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Celgene Corporation:

Celgene
Revlimid
CC-5013
Non-hodgkin's lymphoma

Lenalidomide
CC5013
NHL

Additional relevant MeSH terms:

Anti-Infective Agents
Neoplasms by Histologic Type
Immunoproliferative Disorders
Immunologic Factors
Immune System Diseases
Thalidomide
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Lenalidomide
Angiogenesis Inhibitors
Immunosuppressive Agents

Pharmacologic Actions
Anti-Bacterial Agents
Lymphatic Diseases
Neoplasms
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma
Leprostatic Agents

ClinicalTrials.gov processed this record on November 27, 2009