This is a single arm, single stage pilot study of radiation therapy plus durvalumab for tumor-stage cutaneous T-cell lymphoma (CTCL).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Durvalumab 1500mg IV over 1 hour administered within 2-7 days of initiation of radiation, then every 28 days.
Radiation to 1-3 cutaneous tumors: 20 Gy (4 Gy x 5 fractions)
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
The percentage of patients that respond to treatment
Overall Response Rate (ORR) is defined as the percentage of patients that obtain a Complete Response (CR) or Partial Response (PR) to treatment. A global composite scoring system will be used to determine response. Skin, nodes, viscera and blood will be assessed.
Time frame: 1 year post treatment
The percentage of patients that completely respond to treatment
Complete Response Rate (CRR) is defined as the percentage of patients that obtain Complete Response (CR) to treatment. A global composite scoring system will be used to determine response. Skin, nodes, viscera and blood will be assessed.
Time frame: 1 year post treatment
Time to response
The time to response is measured from the start of the treatment until criteria are met for CR or PR. A global composite scoring system will be used to determine response. Skin, nodes, viscera and blood will be assessed.
Time frame: 1 year post treatment
Duration of overall response
The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrence or PD (Progressive disease) is objectively documented. A global composite scoring system will be used to determine response and progression. Skin, nodes, viscera and blood will be assessed.
Time frame: 1 year post treatment
Progression free survival time
Progression-free survival (PFS) is defined as the duration of time from start of treatment to time of progression or death. A global composite scoring system will be used to determine progression. Skin, nodes, viscera and blood will be assessed.
Time frame: 1 year post treatment
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Time to next treatment
Time to next treatment is defined as the duration of time from start of study treatment to next treatment or death of any cause, whichever comes first.
Time frame: 1 year post treatment