Long-Term Followup and/or Thalidomide Maintenance Therapy for Patients Enrolled on Clinical Trial 20030165
Status: | Active, not recruiting |
---|---|
Conditions: | Lymphoma, Lymphoma |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/4/2019 |
Start Date: | November 24, 2015 |
End Date: | November 2020 |
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.
thalidomide (THALOMID) therapy to those patients enrolled in 20030165. Patients will be
followed until withdrawal of consent, or death.
The study is designed to provide long-term follow-up and/or to offer continued maintenance
thalidomide (THALOMID®) therapy to those patients enrolled in 20030165.
- Group A: Patients who achieved complete response (CR) in 20030165 and continue to
receive maintenance Thalidomide.
- Group B: Patients who achieved complete response (CR) in 20030165, but are not receiving
maintenance Thalidomide.
- Group C: All other patients enrolled in 20030165 who expired or experienced disease
progression.
Thalidomide (THALOMID®) will be administered as per standard of care guidelines to Group A;
in compliance with Risk Evaluation and Mitigation Strategy (REMS™) program requirements.
Patients in Group A, B and C will be followed until withdrawal of consent, or death. All
other patients in Group C who expired on 20030165 will also be included in all analyses.
thalidomide (THALOMID®) therapy to those patients enrolled in 20030165.
- Group A: Patients who achieved complete response (CR) in 20030165 and continue to
receive maintenance Thalidomide.
- Group B: Patients who achieved complete response (CR) in 20030165, but are not receiving
maintenance Thalidomide.
- Group C: All other patients enrolled in 20030165 who expired or experienced disease
progression.
Thalidomide (THALOMID®) will be administered as per standard of care guidelines to Group A;
in compliance with Risk Evaluation and Mitigation Strategy (REMS™) program requirements.
Patients in Group A, B and C will be followed until withdrawal of consent, or death. All
other patients in Group C who expired on 20030165 will also be included in all analyses.
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.
We found this trial at
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University of Miami A private research university with more than 15,000 students from around the...
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