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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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T-cell Non-Hodgkin's Lymphoma

Intervention / Treatment
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* Drug: Lenalidomide


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lenalidomide<br>Open-label, oral lenalidomide monotherapy | Drug: Lenalidomide<br>* Lenalidomide capsules, 25 mg daily for 21 days in each 28 day cycle<br>* Other names: Revlimid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants Categorized by Best Response as Determined by Investigator | 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 | Up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Response | 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. | Up to 24 months | 
| Time-to-Progression | 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. | Up to 24 months | 
| Progression-Free Survival | 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. | Up to 24 months | 
| Safety | 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.) | Up to 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NHL, Non-Hodgkin's Lymphoma, T-cell Lymphoma