Radiation Therapy Plus Durvalumab for Tumor-Stage Cutaneous T-Cell Lymphoma

Withdrawn before enrolling · Early Phase 1

Conditions studied: Cutaneous T Cell Lymphoma

In brief

This is a single arm, single stage pilot study of radiation therapy plus durvalumab for tumor-stage cutaneous T-cell lymphoma (CTCL).

Key facts

Study ID

NCT03235869

Run by

University of Michigan Rogel Cancer Center

People needed

0

Starts

2018-03-01

Expected to finish

2023-03-01

Last updated by the study team

2018-03-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• University of Michigan Comprehensive Cancer Center — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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