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A Phase II Study of Single-Agent Lenalidomide in Subjects With Relapsed Or Refractory T-Cell Non-Hodgkin's Lymphoma (EXPECT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00655668
Recruitment Status : Terminated (Decision not to pursue as single agent in the study population.)
First Posted : April 10, 2008
Results First Posted : January 5, 2012
Last Update Posted : November 25, 2019
Information provided by (Responsible Party):

Brief Summary:

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.



• 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.


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

Condition or disease Intervention/treatment Phase
T-cell Non-Hodgkin's Lymphoma Drug: Lenalidomide Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Actual Study Start Date : March 1, 2008
Actual Primary Completion Date : March 1, 2010
Actual Study Completion Date : April 1, 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Participants Categorized by Best Response as Determined by Investigator [ Time Frame: Up to 24 months ]

    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 :
  1. Duration of Response [ Time Frame: Up to 24 months ]
    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.

  2. Time-to-Progression [ Time Frame: Up to 24 months ]
    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.

  3. Progression-Free Survival [ Time Frame: Up to 24 months ]
    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.

  4. Safety [ Time Frame: Up to 24 months ]
    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: Following is the scale: Grade 1=Mild Adverse Event (AE), Grade 2=Moderate AE, Grade 3=Severe and Undesirable AE, Grade 4=Life-threatening or Disabling AE, and Grade 5=Death Related to AE.)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00655668

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Sponsors and Collaborators
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Study Director: Kenichi Takeshita, MD Celgene Corporation
Publications of Results:
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Responsible Party: Celgene Identifier: NCT00655668    
Other Study ID Numbers: CC-5013-TCL-001
2007-002171-13 ( EudraCT Number )
First Posted: April 10, 2008    Key Record Dates
Results First Posted: January 5, 2012
Last Update Posted: November 25, 2019
Last Verified: November 2019
Keywords provided by Celgene:
NHL, Non-Hodgkin's Lymphoma, T-cell Lymphoma
Additional relevant MeSH terms:
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Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Lymphoma, Non-Hodgkin
Lymphoma, T-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Immunologic Factors
Physiological Effects of Drugs
Growth Substances
Growth Inhibitors
Antineoplastic Agents