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NCT03843528 · ClinicalTrials.gov registry record · Phase 1
Vorinostat Dose-escalation After Allogeneic Hematopoietic Cell Transplantation
A Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndromes, sponsored by Johns Hopkins All Children's Hospital.
- Active
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT03843528: Active Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndromes, sponsored by Johns Hopkins All Children's Hospital.
NCT03843528 is a Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndromes that is active but no longer recruiting, run by Johns Hopkins All Children's Hospital. The registered enrollment target is 15 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03843528, a Phase 1 study of Acute Myeloid Leukemia and Myelodysplastic Syndromes, is active but no longer recruiting, sponsored by Johns Hopkins All Children's Hospital.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
Study Summary
The objective of this study is to evaluate the maximum tolerated (MTD) of vorinostat used in combination with low-dose azacitidine after allogeneic hematopoietic cell transplantation (alloHCT) for prevention of relapse of childhood myeloid malignancies.
Primary Outcome
The primary outcome of this study is to determine the MTD of vorinostat in combination with low-dose azacitidine, using dose-escalation methodology. This is based on toxicities developed by participants enrolled on the study.
Conditions Studied
Interventions
- DRUG Azacitidine Injection
- DRUG Vorinostat
Study Locations (1)
Florida
- Johns Hopkins All Children's Hospital - St. Petersburg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2019-05-01 |
| Est. Completion | 2026-10-30 |
| Phase | Phase 1 |
What the registry record for NCT03843528 still lists
NCT03843528 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (87% lower).
The record links to 4 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 2 interventions - of which Azacitidine Injection is the first listed.
NCT03843528 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT03843528 about?
NCT03843528 is a clinical study titled "Vorinostat Dose-escalation After Allogeneic Hematopoietic Cell Transplantation". The objective of this study is to evaluate the maximum tolerated (MTD) of vorinostat used in combination with low-dose azacitidine after allogeneic hematopoietic cell transplantation (alloHCT) for prevention of relapse of childhood myeloid malignancies.
What is the current status of trial NCT03843528?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2019-05-01. Estimated completion is 2026-10-30.
What conditions does trial NCT03843528 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia, Myelodysplastic Syndromes, Mixed Phenotype Acute Leukemia, Juvenile Myelomonocytic Leukemia.
What interventions are being tested in trial NCT03843528?
The interventions under investigation include: Azacitidine Injection (DRUG), Vorinostat (DRUG).
Who is sponsoring clinical trial NCT03843528?
This trial is sponsored by Johns Hopkins All Children's Hospital, which has 24 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03843528 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03843528's enrollment target sits among peer trials
15 274th of 306 higher than 24 of 306 other Acute Myeloid Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Myeloid Leukemia 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.
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