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

Phase 2

Terminated

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.

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: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Lenalidomide	Lenalidomide	Open-label, oral lenalidomide monotherapy

Primary Outcome Measures

Name	Time	Method
Participants Categorized by Best Response as Determined by Investigator	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

Name	Time	Method
Duration of Response	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.
Time-to-Progression	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.
Progression-Free Survival	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.
Safety	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.)

Locations (45): Tower Cancer Research Foundation
🇺🇸
Beverly Hills, California, United States
Cancer Center of Kansas
🇺🇸
Wichita, Kansas, United States
Hackensack University Medical Center
🇺🇸
Hackensack, New Jersey, United States
Western Pennsylvania Hospital
🇺🇸
Pittsburgh, Pennsylvania, United States
The Canberra Hospital Building 3, L 2
🇦🇺
Garran, Australian Capital Territory, Australia
Cancer Therapy Centre
🇦🇺
Liverpool, New South Wales, Australia
Clinical Research Unit Cairns Base Hospital
🇦🇺
Cairns, Queensland, Australia
The Townsville Hospital
🇦🇺
Douglas, Queensland, Australia
Royal Brisbane & Women's Hospital
🇦🇺
Herston, Queensland, Australia
Ashford Cancer Centre
🇦🇺
Ashford, South Australia, Australia
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Tower Cancer Research Foundation
🇺🇸Beverly Hills, California, United States