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Status: | Withdrawn |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 |
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).
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
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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