Clincosm LogoSign in Get a demo

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

Sponsor
University of Miami (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02507336
Collaborator
(none)
2
Enrollment
1
Location
3
Arms
95.2
Anticipated Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
2 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Long-term Follow-up and/or Continued Thalidomide (THALOMID®) Maintenance Therapy for Patients Enrolled on Clinical Trial 20030165
Actual Study Start Date :
Nov 24, 2015
Anticipated Primary Completion Date :
Nov 1, 2023
Anticipated Study Completion Date :
Nov 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Drug: Thalidomide
100-300 mg capsule taken by mouth once daily.
Other Names:
  • Thalomid

    		•
    No Intervention: 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.
    No Intervention: 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.

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Overall Survival (OS) [Up to five years]

      OS is defined as the elapsed time from start of treatment until death or date of censoring.

    2. Response Rate (RR) [Up to five years]

      Response rate is defined as the percentage of patients whose cancer shrinks or disappears after treatment.

    3. Proportion 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Miami Miami Florida United States 33136

    Sponsors and Collaborators

    • University of Miami

    Investigators

    • Principal Investigator: Izidore Lossos, MD, University of Miami

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Izidore Lossos, MD, Professor, University of Miami
    ClinicalTrials.gov Identifier:
    NCT02507336
    Other Study ID Numbers:
    • 20150402
    First Posted:
    Jul 23, 2015
    Last Update Posted:
    Sep 16, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Lymphoma
    Lymphoma, Mantle-Cell
    Thalidomide

    Study Results

    No Results Posted as of Sep 16, 2021