Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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.

View on ClinicalTrials.gov ↗

View your shortlist →

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

FieldValue
Enrollment Target 48 participants
Start Date 2026-08-01
Est. Completion 2030-11-01
Phase Phase 1
Sawa Ito, MD

3 total trials

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.

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

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

  • NCT01765777 · 48 participants · NA

    Efficacy of Osteopathic Manipulative Medicine (OMM) and Phototherapy for Patients With Chronic Lower Back Pain

  • NCT03073343 · 48 participants · NA

    A Prospective, Randomized, Open Label Trial of Two Doses of Oral Betaine

  • NCT03431064 · 48 participants

    Lung Recruitment Maneuver as a Potential Predictor of Fluid Responsiveness in Mechanically Ventilated Pediatric Patients

  • NCT03514602 · 48 participants · NA

    Maternal Smoking Cessation and Pediatric Obesity Prevention

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

Source: ClinicalTrials.gov NCT07565220, the US trial registry maintained by the National Library of Medicine. NCT07565220 (small enrollment · none site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.