Back to resultsLong-Term Followup and/or Thalidomide Maintenance Therapy for Patients Enrolled on Clinical Trial 20030165
Primary Purpose
Mantle Cell Lymphoma, Non-Hodgkin's Lymphoma
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Thalidomide
Sponsored by
About this trial
This is an interventional supportive care trial for Mantle Cell Lymphoma
Eligibility Criteria
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.
Sites / Locations
- University of Miami
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
No Intervention
No Intervention
Arm Label
Group A - CR+Thalidomide
Group B - CR+No Thalidomide
Group C - PD or Expired
Arm 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.
Patients who achieved complete response (CR) in 20030165, but are not receiving maintenance Thalidomide. Patients will receive annual clinical/laboratory evaluations.
All other patients enrolled in 20030165 who expired or experienced disease progression (PD). Patients will be followed annually for survival.
Outcomes
Primary Outcome Measures
Progression-free survival (PFS)
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
Overall Survival (OS)
OS is defined as the elapsed time from start of treatment until death or date of censoring.
Response Rate (RR)
Response rate is defined as the percentage of patients whose cancer shrinks or disappears after treatment.
Proportion of Participants Experiencing Treatment-Emergent Adverse Events
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02507336
Brief Title
Long-Term Followup and/or Thalidomide Maintenance Therapy for Patients Enrolled on Clinical Trial 20030165
Official Title
Long-term Follow-up and/or Continued Thalidomide (THALOMID®) Maintenance Therapy for Patients Enrolled on Clinical Trial 20030165
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
November 24, 2015 (Actual)
Primary Completion Date
August 2, 2023 (Actual)
Study Completion Date
August 2, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
4. Oversight
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
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mantle Cell Lymphoma, Non-Hodgkin's Lymphoma
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A - CR+Thalidomide
Arm Type
Experimental
Arm 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.
Arm Title
Group B - CR+No Thalidomide
Arm Type
No Intervention
Arm Description
Patients who achieved complete response (CR) in 20030165, but are not receiving maintenance Thalidomide. Patients will receive annual clinical/laboratory evaluations.
Arm Title
Group C - PD or Expired
Arm Type
No Intervention
Arm Description
All other patients enrolled in 20030165 who expired or experienced disease progression (PD). Patients will be followed annually for survival.
Intervention Type
Drug
Intervention Name(s)
Thalidomide
Other Intervention Name(s)
Thalomid
Intervention Description
100-300 mg capsule taken by mouth once daily.
Primary Outcome Measure Information:
Title
Progression-free survival (PFS)
Description
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).
Time Frame
Up to five years
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
OS is defined as the elapsed time from start of treatment until death or date of censoring.
Time Frame
Up to five years
Title
Response Rate (RR)
Description
Response rate is defined as the percentage of patients whose cancer shrinks or disappears after treatment.
Time Frame
Up to five years
Title
Proportion of Participants Experiencing Treatment-Emergent Adverse Events
Description
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.
Time Frame
Up to five years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Izidore Lossos, MD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
20038221
Citation
Lossos IS, Hosein PJ, Morgensztern D, Coleman F, Escalon MP, Byrne GE Jr, Rosenblatt JD, Walker GR. High rate and prolonged duration of complete remissions induced by rituximab, methotrexate, doxorubicin, cyclophosphamide, vincristine, ifosfamide, etoposide, cytarabine, and thalidomide (R-MACLO-IVAM-T), a modification of the National Cancer Institute 89-C-41 regimen, in patients with newly diagnosed mantle cell lymphoma. Leuk Lymphoma. 2010 Mar;51(3):406-14. doi: 10.3109/10428190903518345.
Results Reference
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Long-Term Followup and/or Thalidomide Maintenance Therapy for Patients Enrolled on Clinical Trial 20030165
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