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NCT03278782 · ClinicalTrials.gov registry record · Phase 1
Study of Pembrolizumab (MK-3475) in Combination With Romidepsin
A Phase 1 study of Recurrent Mycosis Fungoides and Recurrent Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Phase 1
- Development phase
- 39
- Enrollment target
- 1
- Study location
NCT03278782: Active Phase 1 study of Recurrent Mycosis Fungoides and Recurrent Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, sponsored by M.D. Anderson Cancer Center.
NCT03278782 is a Phase 1 study of Recurrent Mycosis Fungoides and Recurrent Primary Cutaneous T-Cell Non-Hodgkin Lymphoma that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 39 participants, below the 60-participant average among 6 other Recurrent Mycosis Fungoides trials with a reported enrollment target (35% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03278782, a Phase 1 study of Recurrent Mycosis Fungoides and Recurrent Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 39 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I/II trial studies the side effects of pembrolizumab and romidepsin and to see how well they work in treating participants with peripheral T-cell lymphoma that has come back or that does not respond to treatment. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Romidepsin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving pembrolizumab and romidepsin may work better than pembrolizumab alone in treating participants with recurrent or refractory peripheral T-cell lymphoma.
Primary Outcome
As determined by incidence of adverse events graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The phase I portion of the study follows standard 3+3 design. The 6 patients tested in the phase I at the dose finally determined as recommended phase II dose (RP2D) will be included in the response assessment of phase II study. Toxicity data will be summarized by type and severity for all patients who received the treatment regardless of the eligibility nor the du
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- DRUG Romidepsin
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2017-11-14 |
| Est. Completion | 2027-07-31 |
| Phase | Phase 1 |
What the registry record for NCT03278782 still lists
NCT03278782 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 60-participant average among 6 other Recurrent Mycosis Fungoides trials with a reported enrollment target (35% lower).
The record links to 10 conditions, with Recurrent Mycosis Fungoides appearing as the primary indexed condition, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT03278782 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT03278782 about?
NCT03278782 is a clinical study titled "Study of Pembrolizumab (MK-3475) in Combination With Romidepsin". This phase I/II trial studies the side effects of pembrolizumab and romidepsin and to see how well they work in treating participants with peripheral T-cell lymphoma that has come back or that does not respond to treatment. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help th...
What is the current status of trial NCT03278782?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 39 participants. The study started on 2017-11-14. Estimated completion is 2027-07-31.
What conditions does trial NCT03278782 study?
This clinical trial studies the following conditions: Recurrent Mycosis Fungoides, Recurrent Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory Mycosis Fungoides, Recurrent Anaplastic Large Cell Lymphoma, Recurrent Angioimmunoblastic T-Cell Lymphoma.
What interventions are being tested in trial NCT03278782?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Romidepsin (DRUG).
Who is sponsoring clinical trial NCT03278782?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03278782 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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