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

Phase 2

Completed

• Conditions: Mantle Cell Lymphoma; Non-Hodgkin's Lymphoma
• Interventions: Drug: Thalidomide

• Registration Number: NCT02507336
• Lead Sponsor: University of Miami

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-07-22
• Study First Submitted QC: 2015-07-22
• Study First Posted: 2015-07-23
• Study Start: 2015-11-24
• Primary Completion: 2023-08-02
• Study Completion: 2023-08-02
• Status Verified: 2024-07
• Results First Submitted: 2024-07-03
• Results First Submitted QC: 2024-07-31
• Last Update Submitted: 2024-07-31
• Results First Posted: 2024-08-01
• Last Update Posted: 2024-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A - CR+Thalidomide	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.

Primary Outcome Measures

Name	Time	Method
Progression-free Survival (PFS)	Up to five years	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).

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS)	Up to five years	OS is defined as the elapsed time from start of treatment until death or date of censoring.
Response Rate (RR)	Up to five years	Response rate is defined as the percentage of participants whose cancer shrinks or disappears after treatment.
Percentage of Participants Experiencing Treatment-Emergent Adverse Events	Up to five years	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.

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States