NCT03235869

Brief Summary

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2018

Longer than P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 27, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 1, 2017

Completed
7 months until next milestone

Study Start

First participant enrolled

March 1, 2018

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

March 15, 2018

Status Verified

March 1, 2018

Enrollment Period

5 years

First QC Date

July 27, 2017

Last Update Submit

March 13, 2018

Conditions

Cutaneous T Cell Lymphoma

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (4)

  • Time to response

    1 year post treatment

  • Duration of overall response

    1 year post treatment

  • Progression free survival time

    1 year post treatment

  • Time to next treatment

    1 year post treatment

Study Arms (1)

Radiation Therapy + Durvalumab

EXPERIMENTAL

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.

Drug: DurvalumabRadiation: Radiation Therapy

Interventions

DurvalumabDRUG

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

Radiation Therapy + Durvalumab
Radiation TherapyRADIATION

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

Radiation Therapy + Durvalumab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Lymphoma, T-Cell, Cutaneous

Interventions

durvalumabRadiotherapy

Condition Hierarchy (Ancestors)

Lymphoma, T-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • "Ryan Wilcox, M.D., Ph.D.

    University of Michigan Rogel Cancer Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2017

First Posted

August 1, 2017

Study Start

March 1, 2018

Primary Completion

March 1, 2023

Study Completion

March 1, 2023

Last Updated

March 15, 2018

Record last verified: 2018-03

Locations

US(1)