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NCT04187703 · ClinicalTrials.gov registry record · Early Phase 1
5-Azacitidine and Decitabine Epigenetic Therapy for Myeloid Malignancies
A Early Phase 1 study of Myelodysplastic Syndromes and MDS/MPN Crossover Syndromes, sponsored by Benjamin Tomlinson.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT04187703 is a Early Phase 1 study of Myelodysplastic Syndromes and MDS/MPN Crossover Syndromes that is actively recruiting participants, run by Benjamin Tomlinson. The registered enrollment target is 20 participants, below the 285-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04187703, a Early Phase 1 study of Myelodysplastic Syndromes and MDS/MPN Crossover Syndromes, is actively recruiting participants, sponsored by Benjamin Tomlinson.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
Another term for myelodysplastic syndrome is bone marrow failure. The bone marrow is where components of blood such as red cells, platelets and white cells are made. In bone marrow failure, the ability for bone marrow to make these cells is decreased. In myelodysplastic syndrome, this decreased bone marrow function is believed to result from abnormalities that prevent the normal maturation process by which bone marrow cells develop into red blood cells, white blood cells and platelets. In myelodysplastic syndrome, these abnormal bone marrow cells occupy space in the bone marrow and prevent the function of remaining normal bone marrow cells. One approach to treating the abnormal growth of immature cells is to give chemotherapy which damages DNA within these cells and causes their death. Unfortunately, such therapy has side-effects, since even normal cells can be affected by the treatment. Both 5-azacitidine (5AZA) and decitabine (DEC) are FDA-approved to treat MDS. In this study, 5AZA and DEC will be administered using an alternating low doses schedule in an attempt to overcome the known mechanisms of resistance to the administration of 5AZA or DEC as single agents caused by automatic adaptive shifts in DNA metabolism.
Conditions Studied
Interventions
- DRUG Decitabine
- DRUG 5-azacytidine
Study Locations (1)
Ohio
- Cleveland Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2020-11-16 |
| Est. Completion | 2026-12-01 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04187703
The ClinicalTrials.gov registry entry for NCT04187703 describes a study currently listed as recruiting, categorized as Early Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 285-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target (93% lower). The listed sponsor is Benjamin Tomlinson, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Myelodysplastic Syndromes appearing as the primary indexed condition, and to 2 interventions - of which Decitabine is the first listed.
NCT04187703 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.
Frequently Asked Questions
What is clinical trial NCT04187703 about?
NCT04187703 is a clinical study titled "5-Azacitidine and Decitabine Epigenetic Therapy for Myeloid Malignancies". Another term for myelodysplastic syndrome is bone marrow failure. The bone marrow is where components of blood such as red cells, platelets and white cells are made. In bone marrow failure, the ability for bone marrow to make these cells is decreased. In myelodysplastic syndrome, this decreased bone...
What is the current status of trial NCT04187703?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 20 participants. The study started on 2020-11-16. Estimated completion is 2026-12-01.
What conditions does trial NCT04187703 study?
This clinical trial studies the following conditions: Myelodysplastic Syndromes, MDS/MPN Crossover Syndromes.
What interventions are being tested in trial NCT04187703?
The interventions under investigation include: Decitabine (DRUG), 5-azacytidine (DRUG).
Who is sponsoring clinical trial NCT04187703?
This trial is sponsored by Benjamin Tomlinson, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04187703 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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