Cord blood allogeneic hematopoietic stem cell transplantation using Thiotepa combined with low-dose total body irradiation, Fludarabine, Cytarabine, and Cyclophosphamide (TFACT) conditioning regimen.

A clinical study of cord blood allogeneic hematopoietic stem cell transplantation with Thiotepa combined with low-dose total body irradiation, Fludarabine, Cytarabine, and Cyclophosphamide (TFACT regimen) as conditioning therapy for acute leukemia patients with high-risk cytogenetics or positive minimal residual disease prior to transplantation.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2500108003

Enrollment

Unknown

Registered

2025-08-22

Start date

2025-08-29

Completion date

Unknown

Last updated

2025-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukemia, bone marrow failure syndromes, myelodysplastic syndromes (MDS), and lymphoma.

Interventions

Experimental Group:Thiotepa in combination with low-dose TBI, Fludarabine, Cytarabine, and Cyclophosphamide

Eligibility

Sex/Gender

All

Age

14 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Age >=14 years and =18 years and =60 years;

Exclusion criteria

Exclusion criteria: 1.Presence of new or active uncontrolled infection (e.g., fever, unexplained pulmonary imaging abnormality, or sinusitis; infections occurring within 4 weeks prior to enrollment must be controlled or resolved before treatment). 2.Presence of severe cardiac, hepatic, or renal insufficiency or other significant diseases. 3.Presence of severe autoimmune diseases or immunodeficiency diseases. 4.History of severe allergies (hypersensitivity). 5.Presence of severe psychiatric disorders. 6.Participation in or current enrollment in other clinical trials within the past 3 months. 7.Active central nervous system (CNS) leukemia identified within 2 weeks prior to enrollment (e.g., patients with prior CNS leukemia require two consecutive negative cerebrospinal fluid (CSF) tests performed more than 1 week apart. Patients with prior cranial radiotherapy must be assessed as able to tolerate a 4Gy radiation dose). 8.Patients planning pregnancy, currently pregnant, or breastfeeding. 9.Subjects of childbearing potential judged by the investigator to be using inadequate contraceptive measures. 10.Patients deemed unsuitable for participation in this trial by the investigator. Donor exclusion criteria High-titer (> 3000 MFI) recipient-derived HLA antibodies against the donor were detected by Luminex

Design outcomes

Primary

Measure	Time frame
The overall survival at day 100 after transplantation;	—

Secondary

Measure	Time frame
Progression free survival;Platelet recovery time;Neutrophil recovery time;Chornic graft-versus-host disease;Relapse after transplantation;Acute graft-versus-host disease;Overall Survival;	—

Countries

China

Contacts

Public ContactPengfei Shi

Hangzhou First People's Hospital

pengfeishi@126.com+86 571 56006842

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026