A Phase II Study of Single-Agent Lenalidomide in Subjects With Relapsed Or Refractory T-Cell Non-Hodgkin's Lymphoma (EXPECT)
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.
|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|
- 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
- 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: 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.)
|Study Start Date:||March 2008|
|Study Completion Date:||April 2010|
|Primary Completion Date:||March 2010 (Final data collection date for primary outcome measure)|
Open-label, oral lenalidomide monotherapy
Lenalidomide capsules, 25 mg daily for 21 days in each 28 day cycle
Other Name: Revlimid
Please refer to this study by its ClinicalTrials.gov identifier: NCT00655668
Show 45 Study Locations
|Study Director:||Kenichi Takeshita, MD||Celgene Corporation|