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

Cutaneous T Cell Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03235869
• Other study ID #: UMCC 2017.079
• Secondary ID: HUM00131550
• Status: Withdrawn
• Phase: Early Phase 1
• First received: July 27, 2017
• Last updated: March 13, 2018
• Start date: March 1, 2018
• Est. completion date: March 1, 2023

Study information

• Verified date: March 2018
• Source: University of Michigan Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 1, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cutaneous T Cell Lymphoma
• Lymphoma
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Cutaneous

Intervention

Drug:
• Durvalumab
Durvalumab 1500mg IV over 1 hour administered within 2-7 days of initiation of radiation, then every 28 days.

Radiation:
• Radiation Therapy
Radiation to 1-3 cutaneous tumors: 20 Gy (4 Gy x 5 fractions)

Locations

Country	Name	City	State
United States	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year post treatment
Primary	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.	1 year post treatment
Secondary	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.	1 year post treatment
Secondary	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.	1 year post treatment
Secondary	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.	1 year post treatment
Secondary	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.	1 year post treatment