Status:
WITHDRAWN
Radiation Therapy Plus Durvalumab for Tumor-Stage Cutaneous T-Cell Lymphoma
Lead Sponsor:
University of Michigan Rogel Cancer Center
Conditions:
Cutaneous T Cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
This is a single arm, single stage pilot study of radiation therapy plus durvalumab for tumor-stage cutaneous T-cell lymphoma (CTCL).
Eligibility Criteria
Inclusion
- Voluntarily provide written IRB-approved consent
- Age ≥ 18 years
- Histologically proven CTCL
- Stage IIB-IV CTCL with ≥2 cutaneous tumors assessable for response
- At least one cutaneous tumor amenable to radiation therapy. Must have at least 1 tumor assessable for response that will not undergo radiation.
- Adequate organ function
- Prior treatment is allowed if at least 4 weeks have elapsed since last chemotherapy and/or radiation and the subject has recovered from all treatment related toxicity
Exclusion
- Prior allogeneic stem cell transplant.
- Prior treatment with a PD-1/PD-L1 inhibitor
- Active or prior documented autoimmune or inflammatory disorders within the past 3 years prior to the start of treatment.
- Current or prior use of immunosuppressive medication within 14 days prior to first dose of durvalumab.
- Known human immunodeficiency virus (HIV), hepatitis C virus (HCV) or active hepatitis B virus (HBV) infection.
- History of hypersensitivity to durvalumab or any excipient
- Receipt of live attenuated vaccination within 30 days prior the first dose of durvalumab.
- Female subjects who are pregnant, breast-feeding or female patients of reproductive potential who are not employing an effective method of birth control
- Male subjects who are not employing an effective method of birth control
- Uncontrolled current medical illness, including, but not limited to ongoing or active infections, symptomatic congestive heart failure, unstable angina pectoris,unstable cardiac arrhythmia and/or psychiatric illness or other condition that in the opinion of the investigator would limit compliance with study requirements.
Key Trial Info
Start Date :
March 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03235869
Start Date
March 1 2018
End Date
March 1 2023
Last Update
March 15 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109