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NCT07565220 · ClinicalTrials.gov registry record · Phase 1
Thiotepa-based Conditioning Regimen With De-escalated Post-graft Cyclophosphamide for Allogeneic Stem Cell Transplantation in Hematologic Malignancies
A Phase 1 study, sponsored by Sawa Ito, MD.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
NCT07565220: Recruiting Phase 1 study, sponsored by Sawa Ito, MD.
NCT07565220 is a Phase 1 study that is actively recruiting participants, run by Sawa Ito, MD. The registered enrollment target is 48 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07565220, a Phase 1 study, is actively recruiting participants, sponsored by Sawa Ito, MD.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
Study Summary
This phase 1 trial will investigate the safety and effectiveness of Thiotepa, Busulfan, and Fludarabine (TBF) conditioning regimen with post-transplant cyclophosphamide (PTCy) in HLA-matched related or unrelated donor allogeneic stem cell transplantation (alloSCT).
Primary Outcome
Graft Versus Host Disease (GVHD)-free, relapse-free survival (GRFS) is defined by survival without a qualifying event including Death, Relapse of primary disease, Grade III-IV acute graft-versus-host disease (GVHD), graded via MAGIC criteria, Chronic moderate or severe GVHD requiring systemic immunosuppression, graded via NIH consensus criteria.
Interventions
- DRUG Fludarabine
- DRUG Busulfan
- DRUG Thiotepa
- PROCEDURE PBSC infusion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2026-08-01 |
| Est. Completion | 2030-11-01 |
| Phase | Phase 1 |
What NCT07565220 shows while recruiting
NCT07565220 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower).
The record links to 0 conditions, and to 4 interventions - of which Fludarabine is the first listed.
NCT07565220 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07565220 about?
NCT07565220 is a clinical study titled "Thiotepa-based Conditioning Regimen With De-escalated Post-graft Cyclophosphamide for Allogeneic Stem Cell Transplantation in Hematologic Malignancies". This phase 1 trial will investigate the safety and effectiveness of Thiotepa, Busulfan, and Fludarabine (TBF) conditioning regimen with post-transplant cyclophosphamide (PTCy) in HLA-matched related or unrelated donor allogeneic stem cell transplantation (alloSCT).
What is the current status of trial NCT07565220?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2026-08-01. Estimated completion is 2030-11-01.
What interventions are being tested in trial NCT07565220?
The interventions under investigation include: Fludarabine (DRUG), Busulfan (DRUG), Thiotepa (DRUG), PBSC infusion (PROCEDURE).
Who is sponsoring clinical trial NCT07565220?
This trial is sponsored by Sawa Ito, MD, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07565220's enrollment target sits among peer trials
48 1025th of 2000 higher than 948 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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