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



Status:Withdrawn
Conditions:Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/17/2018
Start Date:March 1, 2018
End Date:March 1, 2023

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A Single Arm Pilot Study of Radiation Therapy Plus Durvalumab for Tumor-Stage Cutaneous T-Cell Lymphoma

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


Inclusion Criteria:

- 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 Criteria:

- 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.
We found this trial at
1
site
1500 East Medical Center Drive
Ann Arbor, Michigan 48109
800-865-1125
University of Michigan Comprehensive Cancer Center The U-M Comprehensive Cancer Center's mission is the conquest...
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mi
from
Ann Arbor, MI
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