Long-Term Followup and/or Thalidomide Maintenance Therapy for Patients Enrolled on Clinical Trial 20030165

Study Overview
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Brief Summary
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The study seeks to provide long-term follow-up and/or to offer continued maintenance thalidomide (THALOMID) therapy to those patients enrolled in 20030165. Patients will be followed until withdrawal of consent, or death.

Official Title
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Long-term Follow-up and/or Continued Thalidomide (THALOMID®) Maintenance Therapy for Patients Enrolled on Clinical Trial 20030165

Conditions
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Mantle Cell Lymphoma, Non-Hodgkin's Lymphoma

Intervention / Treatment
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* Drug: Thalidomide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Enrolled on the 20030165 clinical trial. Ability to understand and willingness to sign a written informed consent document. Exclusion Criteria: Patients who were discontinued from 20030165 for any reason prior to the completion of protocol-specified treatment (e.g. withdrawal of consent). Uncontrolled, intercurrent serious illness including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, and/or cardiac arrhythmia likely in the judgment of the PI to interfere with clinical study requirements. Psychiatric illness/condition likely in the judgment of the PI to limit compliance with clinical study requirements.

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: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A - CR+Thalidomide<br>Patients who achieved complete response (CR) in 20030165 and continue to receive maintenance Thalidomide. Patients in Group A will receive daily oral thalidomide (THALOMID®) as per standard of care and THALOMID® REMS™ guidelines. Patients will continue with thalidomide (THALOMID®) as per standard of care guidelines, until progression of disease, discontinuation due to toxicity, death or study withdrawal. Patients will receive annual clinical/laboratory evaluations. | Drug: Thalidomide<br>* 100-300 mg capsule taken by mouth once daily.<br>* Other names: Thalomid;|
| No Intervention: Group B - CR+No Thalidomide<br>Patients who achieved complete response (CR) in 20030165, but are not receiving maintenance Thalidomide. Patients will receive annual clinical/laboratory evaluations. | |
| No Intervention: Group C - PD or Expired<br>All other patients enrolled in 20030165 who expired or experienced disease progression (PD). Patients will be followed annually for survival. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival (PFS) | PFS is defined as the length of time, during and after treatment, until documented disease progression or death (by any cause, in the absence of progression). | Up to five years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) | OS is defined as the elapsed time from start of treatment until death or date of censoring. | Up to five years | 
| Response Rate (RR) | Response rate is defined as the percentage of patients whose cancer shrinks or disappears after treatment. | Up to five years | 
| Proportion of Participants Experiencing Treatment-Emergent Adverse Events | Treatment emergent adverse events will be assessed by treating physician using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 3.0. | Up to five years |