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Thiotepa-based Conditioning Regimen With De-escalated Post-graft Cyclophosphamide for Allogeneic Stem Cell Transplantation in Hematologic Malignancies

NCT07565220 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2026-05-04

No results posted yet for this 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).

Conditions

  • Acute Lymphocytic Leukemia (ALL)
  • Acute Myeloid Leukemia (AML)
  • Acute Leukemia
  • Myelodysplastic Syndrome(MDS)
  • High-risk Myeloproliferative Neoplasm (MPN)

Interventions

DRUG

Thiotepa

Thiotepa is an alkylating agent used in combination with other chemotherapy agents to treat cancer.

DRUG

Fludarabine

Fludarabine is a chemotherapy drug used in the treatment of chronic lymphocytic leukemia. It acts at DNA polymerase alpha, ribonucleotide reductase and DNA primase, results in the inhibition of DNA synthesis, and destroys the cancer cells.

DRUG

Busulfan

Busulfan is a chemotherapy drug used in preparation for a stem cell transplant.

PROCEDURE

PBSC infusion

Peripheral Blood Stem Cell (PBSC) infusion is a medical procedure used to replace diseased or damaged stem cells in patients, particularly after cancer treatments.

Sponsors & Collaborators

  • Sawa Ito, MD

    lead OTHER

Principal Investigators

  • Sawa M Ito, MD · UPMC Hillman Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2029-06-01
Completion
2030-11-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07565220 on ClinicalTrials.gov