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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-24

Study Completion Date

2023-08-02

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.

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Detailed Description

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Conditions

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Mantle Cell Lymphoma Non-Hodgkin's Lymphoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Group A - CR+Thalidomide

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.

Group Type EXPERIMENTAL

Thalidomide

Intervention Type DRUG

100-300 mg capsule taken by mouth once daily.

Group B - CR+No Thalidomide

Patients who achieved complete response (CR) in 20030165, but are not receiving maintenance Thalidomide. Patients will receive annual clinical/laboratory evaluations.

Group Type NO_INTERVENTION

No interventions assigned to this group

Group C - PD or Expired

All other patients enrolled in 20030165 who expired or experienced disease progression (PD). Patients will be followed annually for survival.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Thalidomide

100-300 mg capsule taken by mouth once daily.

Intervention Type DRUG

Other Intervention Names

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Thalomid

Eligibility Criteria

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Inclusion Criteria

1. Enrolled on the 20030165 clinical trial.
2. Ability to understand and willingness to sign a written informed consent document.

Exclusion Criteria

1. Patients who were discontinued from 20030165 for any reason prior to the completion of protocol-specified treatment (e.g. withdrawal of consent).
2. 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.
3. Psychiatric illness/condition likely in the judgment of the PI to limit compliance with clinical study requirements.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No