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

Use our guide to learn which trials are right for you!

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.

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.

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
1
site
Miami, Florida 33124
(305) 284-2211
University of Miami A private research university with more than 15,000 students from around the...
?
mi
from
Miami, FL
Click here to add this to my saved trials