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Withdrawn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

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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By research site
University of Michigan Comprehensive Cancer Center· Ann Arbor, MI

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