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NCT05796570 · ClinicalTrials.gov registry record · Phase 2
A Pilot Study to Evaluate the Feasibility of Post-Hematopoietic Stem Cell Transplant Prophylaxis With Decitabine Combined With Filgrastim for Children and Young Adults With AML, MDS and Related Myeloid Malignancies
A Phase 2 study of Acute Myeloid Leukemia and Myelodysplastic Syndromes, sponsored by Franziska Wachter.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 37
- Enrollment target
- 2
- Study locations
NCT05796570: Recruiting Phase 2 study of Acute Myeloid Leukemia and Myelodysplastic Syndromes, sponsored by Franziska Wachter.
NCT05796570 is a Phase 2 study of Acute Myeloid Leukemia and Myelodysplastic Syndromes that is actively recruiting participants, run by Franziska Wachter. The registered enrollment target is 37 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (68% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05796570, a Phase 2 study of Acute Myeloid Leukemia and Myelodysplastic Syndromes, is actively recruiting participants, sponsored by Franziska Wachter.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 37 participants
- Enrollment target
- 2
- Study locations
Study Summary
The purpose of this study is to examine if it is feasible to administer decitabine and filgrastim after allogenic hematopoietic stem cell transplant (HCT) in children and young adults with myelodysplastic syndrome, acute myeloid leukemia and related myeloid disorders, and if the treatment is effective in preventing relapse after HCT. The names of the study drugs involved in this study are: * Decitabine (a nucleoside metabolic inhibitor) * Filgrastim (a recombinant granulocyte colony-stimulating factor (G-CSF)
Primary Outcome
Feasibility failure relates to decitabine exposure in the setting of post-hematopoietic stem cell transplant (HCT) maintenance and in combination with filgrastim; FFR is defined as the proportion of participants that do not initiate at least 5 of 6 planned cycles and/or receive fewer than 22/30 overall planned decitabine doses during maintenance phase.
Conditions Studied
Interventions
- DRUG Decitabine
- DRUG Filgrastim
Study Locations (2)
Massachusetts
- Boston Children's Hospital - Boston
- Dana-Farber Cancer Institute - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2023-04-19 |
| Est. Completion | 2029-09-01 |
| Phase | Phase 2 |
What NCT05796570 shows while recruiting
NCT05796570 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (68% lower).
The record links to 7 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 2 interventions - of which Decitabine is the first listed.
NCT05796570 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05796570 about?
NCT05796570 is a clinical study titled "A Pilot Study to Evaluate the Feasibility of Post-Hematopoietic Stem Cell Transplant Prophylaxis With Decitabine Combined With Filgrastim for Children and Young Adults With AML, MDS and Related Myeloid Malignancies". The purpose of this study is to examine if it is feasible to administer decitabine and filgrastim after allogenic hematopoietic stem cell transplant (HCT) in children and young adults with myelodysplastic syndrome, acute myeloid leukemia and related myeloid disorders, and if the treatment is effecti...
What is the current status of trial NCT05796570?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 37 participants. The study started on 2023-04-19. Estimated completion is 2029-09-01.
What conditions does trial NCT05796570 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia, Myelodysplastic Syndromes, AML, MDS, Myeloid Neoplasm.
What interventions are being tested in trial NCT05796570?
The interventions under investigation include: Decitabine (DRUG), Filgrastim (DRUG).
Who is sponsoring clinical trial NCT05796570?
This trial is sponsored by Franziska Wachter, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05796570 being conducted?
This trial has 2 study locations across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05796570's enrollment target sits among peer trials
37 182nd of 306 higher than 124 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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