Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Recruiting Early Phase 1 study of Myelodysplastic Syndromes and MDS/MPN Crossover Syndromes, sponsored by Benjamin Tomlinson.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Overall response rate (ORR) of 5AZA-alt-DEC including: Complete Response (CR) Partial Response (PR) Hematologic improvement (HI), with HI criteria specifically as defined by IWG criteria Therefore, the overall response rate (ORR) = CR + PR + HI
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 |
What NCT04187703 shows while recruiting
NCT04187703 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 285-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target (93% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Myelodysplastic Syndromes
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 NCT04187703's enrollment target sits among peer trials
20 140th of 173 higher than 30 of 173 other Myelodysplastic Syndromes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Myelodysplastic Syndromes 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
-
Hyperbaric Oxygen Therapy and Allogeneic Peripheral Blood Stem Cell (PBSC) Transplant
RECRUITING · Early Phase 1
-
A Pilot, Open-Label Study of Luspatercept for Patients With Lower Risk Myelodysplastic Syndromes (MDS)
RECRUITING · Phase 2
-
Eltrombopag as a Novel Therapeutic Approach for Low-risk MDS and CMML With TET2 Mutations
RECRUITING · Phase 2
-
Luspatercept for Anemia in Lower Risk MDS or Non-proliferative MDS/MPN Neoplasms
RECRUITING · Phase 2
-
A Multi-phase Study of ASTX030 (Azacitidine and Cedazuridine) in Myeloid Neoplasm Alone or in Combination With Venetoclax in AML (AZTOUND Study)
RECRUITING · Phase 2
-
A Phase 1 Study of Orca-Q in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00573339 · 20 participants
Cardiac Magnetic Resonance Imaging (MRI) Normal Reference Control Group Testing
- NCT00692939 · 20 participants · Phase 1
Autologous Stem Cell Transplantation for Crohn's Disease
- NCT00967785 · 20 participants · Phase 1
A Phase I Study of Mozobil in the Treatment of Patients With WHIMS
- NCT01406691 · 20 participants · Phase 4
Light Flashes to Treat Delayed Sleep Phase Disorder (DSPD)
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI