A Phase II Study of Single-Agent Lenalidomide in Subjects With Relapsed Or Refractory T-Cell Non-Hodgkin's Lymphoma - Full Text View

Sponsored by:	Celgene Corporation
Information provided by:	Celgene Corporation
ClinicalTrials.gov Identifier:	NCT00655668

Purpose

This is a Phase II, multicenter, single-arm, open-label study of oral lenalidomide monotherapy administered to subjects with relapsed or refractory T-cell lymphoma. This study will be conducted in two phases: a Treatment Phase and a Follow-up Phase. Subjects who qualify for enrollment into the study will enter the Treatment Phase and receive single-agent lenalidomide 25 mg once daily on Days 1-21 every 28 days (28-day cycles). Subjects may continue participation in the Treatment Phase of the study for a maximum duration of 24 months, or until disease progression or unacceptable AEs develop. All subjects who discontinue the Treatment Phase for any reason will continue to be followed until progression of disease or until next lymphoma treatment is given, whichever comes first, during the Follow-up Phase.

Objectives:

Primary:

To determine the efficacy of lenalidomide monotherapy in relapsed or refractory T-cell NHL. Efficacy will be assessed by measuring the response rate, tumor control rate, duration of response, time to progression and progression free survival.

Secondary:

To evaluate the safety of lenalidomide monotherapy as treatment for subjects with relapsed or refractory T-cell NHL.

Condition	Intervention	Phase
Relapsed or Refractory T-Cell Non-Hodgkin's Lymphoma	Drug: lenalidomide	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label, 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®) in Subjects With Relapsed or Refractory T-Cell Non-Hodgkin's Lymphoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer 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 56 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Tumor control rate [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
Duration of response [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
Time-to-progression [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
Progression-free survival [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
Safety [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	80
Study Start Date:	March 2008
Estimated Study Completion Date:	June 2013
Estimated Primary Completion Date:	November 2012 (Final data collection date for primary outcome measure)

Intervention Details:

lenalidomide capsules, 25mg daily for 21 days in each 28 day cycle

Eligibility

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

Criteria

Inclusion Criteria:

Must understand and voluntarily sign an informed consent form.
Must be ≥ 18 years of age at the time of signing the informed consent form.
Must be able to adhere to the study visit schedule and other protocol requirements.
Biopsy-proven T-cell non-Hodgkin's lymphoma, either:
- PTCL whatever the subtype, or
- CTCL, but only the subtype mycosis fungoides.
Relapsed or refractory to previous therapy for T-cell NHL.
Must have received at least one prior combination chemotherapy regimen. There is no limit on the number of prior therapies.

Exclusion Criteria:

CTCL of subtype Sézary syndrome.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00655668

Contacts

Contact: Helen Johansen

+41 32 729 87 24

Show 46 Study Locations

Sponsors and Collaborators

Celgene Corporation

Investigators

Study Director:

Annette Ervin-Haynes, DO

Celgene Corporation

More Information

No publications provided

Responsible Party:	Celgene Corporation ( Annette Ervin-Haynes, DO )
Study ID Numbers:	CC-5013-TCL-001
Study First Received:	April 4, 2008
Last Updated:	August 19, 2009
ClinicalTrials.gov Identifier:	NCT00655668 History of Changes
Health Authority:	United States: Food and Drug Administration; Australia: Department of Health and Ageing Therapeutic Goods Administration; France: Afssaps - French Health Products Safety Agency; Belgium: Federal Agency for Medicinal Products and Health Products

Study placed in the following topic categories:

Lymphoma, Small Cleaved-cell, Diffuse
Lymphatic Diseases
Immunoproliferative Disorders
Lymphoma, T-Cell

Lenalidomide
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents
Lenalidomide
Pharmacologic Actions
Lymphatic Diseases

Neoplasms
Lymphoma, T-Cell
Therapeutic Uses
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma

ClinicalTrials.gov processed this record on September 09, 2009