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Radiation Therapy Plus Durvalumab for Tumor-Stage Cutaneous T-Cell Lymphoma | Clinical Trials | Clareo Health

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

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

NCT03235869•University of Michigan Rogel Cancer Center

Summary

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Key Dates

Start Date

March 1, 2018

Primary Completion Date

March 1, 2023

Completion Date

March 1, 2023

Last Updated

March 15, 2018

Conditions

Cutaneous T Cell Lymphoma

Interventions

Durvalumab

DRUG

Radiation Therapy

RADIATION

Ruxolitinib Maintenance Post-Hematopoietic Stem Cell Transplant T-Cell Lymphoma

NCT07356245

T-cell LymphomaGraft Versus Host Disease+6 more

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RECRUITING

Systemic Therapies in the Treatment of Cutaneous T-cell Lymphoma

NCT06588868

Cutaneous T Cell LymphomaCutaneous T-Cell Lymphoma/Mycosis Fungoides+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 15, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Ruxolitinib Maintenance Post-Hematopoietic Stem Cell Transplant T-Cell Lymphoma

Systemic Therapies in the Treatment of Cutaneous T-cell Lymphoma

Confirmatory Study of Topical HyBryte™ vs. Placebo for the Treatment of CTCL

Photopheresis in Early-stage Mycosis Fungoides

Study of CAR-T Cells Expressing CD30 and CCR4 for r/r CD30+ HL and CTCL

Outcomes of Cutaneous T-Cell Lymphoma and Graft-Versus-Host Disease With Extracorporeal Photopheresis Treatment