Clinical trial · Interventional
Radiation Therapy Plus Durvalumab for Tumor-Stage Cutaneous T-Cell Lymphoma
A Single Arm Pilot Study of Radiation Therapy Plus Durvalumab for Tumor-Stage Cutaneous T-Cell Lymphoma
NCT03235869CI-TRIAL-00032092withdrawnEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The company pulled durvalumab from heme malignancies
Summary
Brief summary (as posted)
This is a single arm, single stage pilot study of radiation therapy plus durvalumab for tumor-stage cutaneous T-cell lymphoma (CTCL).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cutaneous T Cell Lymphoma | Primary Cutaneous T-Cell Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Durvalumab | Drug | Durvalumab | ALIAS |
| Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Radiation Therapy + Durvalumab
- description
- 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.
- interventionNames
- Drug: Durvalumab
- Radiation: Radiation Therapy
Primary outcomes (2)
- measure
- The percentage of patients that respond to treatment
- timeFrame
- 1 year post treatment
- description
- 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.
- measure
- The percentage of patients that completely respond to treatment
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.