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

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
University of Michigan Rogel Cancer Center
Study ID
NCT03235869
Phase
EARLY_PHASE1
Status
Withdrawn

Conditions

  • Cutaneous T Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab — DRUG
    Durvalumab 1500mg IV over 1 hour administered within 2-7 days of initiation of radiation, then every 28 days.
  • Radiation Therapy — RADIATION
    Radiation to 1-3 cutaneous tumors: 20 Gy (4 Gy x 5 fractions)

Study Details

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

Key Dates

First listed
Aug 1, 2017
Start date
Mar 1, 2018
Status verified
Mar 2018
Primary completion
Mar 1, 2023
Completion
Mar 1, 2023

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Radiation Therapy + Durvalumab
    Radiation to 1-3 cutaneous tumors: 20 Gy (4 Gy x 5 fractions) Durvalumab 1500mg IV over 1 hour administered within 2-7 days of initiation of radiation, then every 28 days.

Primary Outcome Measure

The percentage of patients that respond to treatment [ Time Frame: 1 year post treatment ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Michigan Comprehensive Cancer CenterAnn ArborMichigan48109-

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University of Michigan Comprehensive Cancer Center· Ann Arbor, MI

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