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

Sponsor:	Celgene Corporation
Information provided by (Responsible Party):	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 adverse events 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 Non-Hodgkin's Lymphoma (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
T-cell Non-Hodgkin's Lymphoma	Drug: Lenalidomide	Phase II

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 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:

Participants Categorized by Best Response as Determined by Investigator [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
Participant response assessed by investigator; criteria by B. Cheson in Journal of Clinical Oncology, 1999 (see article for more detail):
- Complete Response(CR): Complete disappearance of all detectable disease
- Complete Response Unconfirmed(CRu): CR, but indeterminate bone marrow
- Partial Response(PR): >50% decrease in six largest nodes/nodal masses
- Stable Disease(SD): Less than PR, but not progressive disease
- Relapsed Disease: In CR/CRu Patients, new lesions seen or increased by >=50% in previous sites
- Progressive Disease(PD): >=50% increase from low in PR/Non-Responders

Secondary Outcome Measures:

Duration of Response [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
Kaplan-Meier Estimate of duration of response calculated as the time from first computed tomography (CT) Scan or magnetic resonance imaging (MRI) that demonstrates at least a partial response to the first documentation of disease progression, including death due to Non-Hodgkin's Lymphoma.
Time-to-Progression [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
Kaplan-Meier estimate of time-to-progression is calculated as the time from the start of study drug therapy to the first documentation of progressive disease.
Progression-Free Survival [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
Kaplan-Meier estimate of progression-free survival is defined as the start of study drug therapy to the first observation of disease progression or death due to any cause.
Safety [ Time Frame: Up to 24 months ] [ Designated as safety issue: Yes ]
Summary of Treatment-Emergent Events in Safety Population (participants with at least one dose of study drug). Events assessed using National Cancer Institute, Common Terminology Criteria for Adverse Events (NCI CTCAE) (Version 3.0).

Enrollment:	54
Study Start Date:	March 2008
Study Completion Date:	April 2010
Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Lenalidomide Open-label, oral lenalidomide monotherapy	Drug: Lenalidomide Lenalidomide capsules, 25 mg daily for 21 days in each 28 day cycle Other Name: Revlimid

Detailed Description:

Study was terminated. Study data assessment revealed that study drug is active, but is not likely to be sufficiently active as a single agent in this population for registration purposes.

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:
- Peripheral T-cell Lymphoma (PTCL) whatever the subtype, or
- Cutaneous T-cell Lymphoma (CTCL), but only the subtype mycosis fungoides.
Relapsed or refractory to previous therapy for T-cell Non-Hodgkin's Lymphoma.
Must have received at least one prior combination chemotherapy regimen. There is no limit on the number of prior therapies.

Exclusion Criteria:

Cutaneous T-cell Lymphoma of subtype Sézary Syndrome.

Contacts and Locations

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

Show 45 Study Locations

Sponsors and Collaborators

Celgene Corporation

Investigators

Study Director:

Kenichi Takeshita, MD

Celgene Corporation

More Information

No publications provided

Responsible Party:	Celgene Corporation
ClinicalTrials.gov Identifier:	NCT00655668 History of Changes
Other Study ID Numbers:	CC-5013-TCL-001, 2007-002171-13
Study First Received:	April 4, 2008
Results First Received:	November 30, 2011
Last Updated:	November 30, 2011
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

Keywords provided by Celgene Corporation:

NHL, Non-Hodgkin's Lymphoma, T-cell Lymphoma

Additional relevant MeSH terms:

Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, T-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lenalidomide
Thalidomide
Antineoplastic Agents

Therapeutic Uses
Pharmacologic Actions
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 February 09, 2012