A multicenter, prospective clinical study on the safety and efficacy of C+BuCy pretreatment regimen in the treatment of high-risk acute leukemia in children

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000032322

Enrollment

Unknown

Registered

2020-04-25

Start date

2020-09-14

Completion date

Unknown

Last updated

2020-09-21

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

Conditions

high-risk acute leukemia

Interventions

Transplantation pretreatment I:2-CdA, Ara-C, G-CSF, CCNU, BU and CTX

Eligibility

Sex/Gender

All

Age

No minimum to 16 Years

Inclusion criteria

Inclusion criteria: 1. Aged < 16 years, sex unlimited; 2. ECOG score was 0-2 with an estimated survival period of more than 6 months; 3. Children with high risk acute leukemia, recurrent acute leukemia, and Myelodysplastic Syndrome (RAEB/RAEBT); 4. No Hematopoietic stem cell transplantation was performed within 6 months prior to admission; 5. Voluntary clinical trial, Sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients with cardiac insufficiency: Ejection Fraction (EF) = 2mg/dl(34.2µmol/L); SCr > 2.5mg/dl (221µmol/L); 3. Because of the severe mobility infection before transplantation, children who could not tolerate pretreatment by assessment of reseacher; 4. The patients who was deemed unfit for joining in this trial by reseachers.

Design outcomes

Primary

Measure	Time frame
2-year overall survival;2-year progress free survival;Acute / chronic graft versus host disease;	—

Secondary

Measure	Time frame
Graft-related adverse reactions;Transplant-related mortality;	—

Countries

China

Contacts

Public ContactHu Shaoyan

Children's Hospital of Soochow University

hushaoyan@suda.edu.cn+86 0512 80692929

Outcome results

None listed

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