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

University of Miami

Status and phase: Completed; Phase 2

Conditions: Non-Hodgkin's Lymphoma; Mantle Cell Lymphoma

Treatments: Drug: Thalidomide

Study type: Interventional

Funder types: Other

Identifiers

NCT02507336

20150402

Details and patient eligibility

About

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.

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2 participants in 3 patient groups

Group A - CR+Thalidomide

Experimental group

Description:

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.

Treatment:

Drug: Thalidomide

Group B - CR+No Thalidomide

No Intervention group

Description:

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

Group C - PD or Expired

No Intervention group

Description:

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