- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02507336
Long-Term Followup and/or Thalidomide Maintenance Therapy for Patients Enrolled on Clinical Trial 20030165
August 30, 2023 updated by: Izidore Lossos, MD, University of Miami
Long-term Follow-up and/or Continued Thalidomide (THALOMID®) Maintenance Therapy for Patients Enrolled on Clinical Trial 20030165
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
2
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Miami, Florida, United States, 33136
- University of Miami
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
100-300 mg capsule taken by mouth once daily.
Other Names:
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free survival (PFS)
Time Frame: 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).
|
Up to five years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Survival (OS)
Time Frame: Up to five years
|
OS is defined as the elapsed time from start of treatment until death or date of censoring.
|
Up to five years
|
Response Rate (RR)
Time Frame: Up to five years
|
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
Time Frame: 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.
|
Up to five years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Izidore Lossos, MD, University of Miami
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 24, 2015
Primary Completion (Actual)
August 2, 2023
Study Completion (Actual)
August 2, 2023
Study Registration Dates
First Submitted
July 22, 2015
First Submitted That Met QC Criteria
July 22, 2015
First Posted (Estimated)
July 23, 2015
Study Record Updates
Last Update Posted (Actual)
August 31, 2023
Last Update Submitted That Met QC Criteria
August 30, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma, Non-Hodgkin
- Lymphoma
- Lymphoma, Mantle-Cell
- Physiological Effects of Drugs
- Anti-Infective Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Anti-Bacterial Agents
- Leprostatic Agents
- Thalidomide
Other Study ID Numbers
- 20150402
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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