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NCT04848064 · ClinicalTrials.gov registry record · Phase 1
Third-Party Natural Killer Cells and Mogamulizumab for the Treatment of Relapsed or Refractory Cutaneous T-cell Lymphomas or Adult T-Cell Leukemia/Lymphoma
A Phase 1 study of Recurrent Primary Cutaneous T-Cell Non-Hodgkin Lymphoma and Recurrent Adult T-Cell Leukemia/Lymphoma, sponsored by John Reneau.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT04848064: Recruiting Phase 1 study of Recurrent Primary Cutaneous T-Cell Non-Hodgkin Lymphoma and Recurrent Adult T-Cell Leukemia/Lymphoma, sponsored by John Reneau.
NCT04848064 is a Phase 1 study of Recurrent Primary Cutaneous T-Cell Non-Hodgkin Lymphoma and Recurrent Adult T-Cell Leukemia/Lymphoma that is actively recruiting participants, run by John Reneau. The registered enrollment target is 12 participants, below the 59-participant average among 4 other Recurrent Primary Cutaneous T-Cell Non-Hodgkin Lymphoma trials with a reported enrollment target (80% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04848064, a Phase 1 study of Recurrent Primary Cutaneous T-Cell Non-Hodgkin Lymphoma and Recurrent Adult T-Cell Leukemia/Lymphoma, is actively recruiting participants, sponsored by John Reneau.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I trial is to find out the best dose, possible benefits and/or side effects of third-party natural killer cells in combination with mogamulizumab in treating patients with cutaneous T-cell lymphoma or adult T-cell leukemia/lymphoma that has come back (relapsed) or does not respond to treatment (refractory). Immunotherapy with third-party natural killer cells, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Mogamulizumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Giving third-party natural killer cells in combination with mogamulizumab may kill more cancer cells.
Primary Outcome
Toxicities will be captured by Common Terminology Criteria for Adverse Events version 5. The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns. The incidence of severe adverse events or toxicities will be described. Will assess the proportion of patients who experience grade 3 or higher non-hematologic toxicity.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- OTHER Quality-of-Life Assessment
- BIOLOGICAL Natural Killer Cell Therapy
- BIOLOGICAL Mogamulizumab
Study Locations (1)
Ohio
- Ohio State University Comprehensive Cancer Center - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2022-05-06 |
| Est. Completion | 2027-01-30 |
| Phase | Phase 1 |
What NCT04848064 shows while recruiting
NCT04848064 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 59-participant average among 4 other Recurrent Primary Cutaneous T-Cell Non-Hodgkin Lymphoma trials with a reported enrollment target (80% lower).
The record links to 4 conditions, with Recurrent Primary Cutaneous T-Cell Non-Hodgkin Lymphoma appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT04848064 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT04848064 about?
NCT04848064 is a clinical study titled "Third-Party Natural Killer Cells and Mogamulizumab for the Treatment of Relapsed or Refractory Cutaneous T-cell Lymphomas or Adult T-Cell Leukemia/Lymphoma". This phase I trial is to find out the best dose, possible benefits and/or side effects of third-party natural killer cells in combination with mogamulizumab in treating patients with cutaneous T-cell lymphoma or adult T-cell leukemia/lymphoma that has come back (relapsed) or does not respond to trea...
What is the current status of trial NCT04848064?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2022-05-06. Estimated completion is 2027-01-30.
What conditions does trial NCT04848064 study?
This clinical trial studies the following conditions: Recurrent Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Recurrent Adult T-Cell Leukemia/Lymphoma, Refractory Adult T-Cell Leukemia/Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma.
What interventions are being tested in trial NCT04848064?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Quality-of-Life Assessment (OTHER), Natural Killer Cell Therapy (BIOLOGICAL), Mogamulizumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT04848064?
This trial is sponsored by John Reneau, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04848064 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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