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NCT03011814 · ClinicalTrials.gov registry record · Phase 1

Durvalumab With or Without Lenalidomide in Treating Patients With Relapsed or Refractory Cutaneous or Peripheral T Cell Lymphoma

A Phase 1 study of Sezary Syndrome and Recurrent Mycosis Fungoides, sponsored by City of Hope Medical Center.

Active
Registry status
Phase 1
Development phase
38
Enrollment target
4
Study locations

NCT03011814: Active Phase 1 study of Sezary Syndrome and Recurrent Mycosis Fungoides, sponsored by City of Hope Medical Center.

NCT03011814 is a Phase 1 study of Sezary Syndrome and Recurrent Mycosis Fungoides that is active but no longer recruiting, run by City of Hope Medical Center. The registered enrollment target is 38 participants, below the 80-participant average among 13 other Sezary Syndrome trials with a reported enrollment target (52% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03011814, a Phase 1 study of Sezary Syndrome and Recurrent Mycosis Fungoides, is active but no longer recruiting, sponsored by City of Hope Medical Center.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
38 participants
Enrollment target
4
Study locations

Study Summary

This randomized phase I/II trial studies the best dose and side effects of durvalumab and to see how well it works with or without lenalidomide in treating patients with cutaneous or peripheral T cell lymphoma that has come back and does not respond to treatment. Monoclonal antibodies, such as durvalumab, may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as lenalidomide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving durvalumab and lenalidomide may work better in treating patients with cutaneous or peripheral T cell lymphoma.

Primary Outcome

CTCL response was used to establish global response, which incorporates nodal, visceral and cutaneous lesions/disease. mSWAT tool was used for documenting responses in skin of patients with CTCL. PTCL specific response assessment criteria per Lugano Classification was used.

Conditions Studied

Sezary Syndrome Recurrent Mycosis Fungoides Refractory Mycosis Fungoides Recurrent Cutaneous T-Cell Non-Hodgkin Lymphoma Folliculotropic Mycosis Fungoides Recurrent Mature T- and NK-Cell Non-Hodgkin Lymphoma Refractory Peripheral T-Cell Lymphoma, Not Otherwise Specified Refractory Cutaneous T-Cell Non-Hodgkin Lymphoma

Interventions

  • BIOLOGICAL Durvalumab
  • OTHER Laboratory Biomarker Analysis
  • DRUG Lenalidomide

Study Locations (4)

California

  • City of Hope Medical Center - Duarte

New York

  • Memorial Sloan-Kettering Cancer Center - New York

Pennsylvania

  • Thomas Jefferson University Hospital - Philadelphia

Texas

  • M D Anderson Cancer Center - Houston

Trial Details

FieldValue
Enrollment Target 38 participants
Start Date 2017-03-08
Est. Completion 2026-08-30
Phase Phase 1
City of Hope Medical Center

582 total trials

What the registry record for NCT03011814 still lists

NCT03011814 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 80-participant average among 13 other Sezary Syndrome trials with a reported enrollment target (52% lower).

The record links to 8 conditions, with Sezary Syndrome appearing as the primary indexed condition, and to 3 interventions - of which Durvalumab is the first listed.

NCT03011814 reports a single indexed study location in California, New York, Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT03011814 about?

NCT03011814 is a clinical study titled "Durvalumab With or Without Lenalidomide in Treating Patients With Relapsed or Refractory Cutaneous or Peripheral T Cell Lymphoma". This randomized phase I/II trial studies the best dose and side effects of durvalumab and to see how well it works with or without lenalidomide in treating patients with cutaneous or peripheral T cell lymphoma that has come back and does not respond to treatment. Monoclonal antibodies, such as durva...

What is the current status of trial NCT03011814?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 38 participants. The study started on 2017-03-08. Estimated completion is 2026-08-30.

What conditions does trial NCT03011814 study?

This clinical trial studies the following conditions: Sezary Syndrome, Recurrent Mycosis Fungoides, Refractory Mycosis Fungoides, Recurrent Cutaneous T-Cell Non-Hodgkin Lymphoma, Folliculotropic Mycosis Fungoides.

What interventions are being tested in trial NCT03011814?

The interventions under investigation include: Durvalumab (BIOLOGICAL), Laboratory Biomarker Analysis (OTHER), Lenalidomide (DRUG).

Who is sponsoring clinical trial NCT03011814?

This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03011814 being conducted?

This trial has 4 study locations across California, New York, Pennsylvania, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Sezary Syndrome

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03011814's enrollment target sits among peer trials

38 6th of 13 higher than 8 of 13 other Sezary Syndrome trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Sezary Syndrome trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT03011814, the US trial registry maintained by the National Library of Medicine. NCT03011814 (small enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.