A perspective multi-centre trial of reduced-intensity allogeneic hematopoietic stem cell transplantation for acute myeloid leukemia using fludarabine, busulphan, and cytarabine (FBA) conditioning

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-08000102

Enrollment

Unknown

Registered

2008-05-31

Start date

2007-12-01

Completion date

Unknown

Last updated

2017-04-18

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

Conditions

acute myeloid leukemia

Interventions

Standard conditioning regimen:(1) related donor: Bulsulfan+cyclophosphamid

(2) unrelated donor: Bulsulfan+cyclophosphamid+anti-thymocyte cell globulin (ATG)

Reduced intensity conditioning regimen:(1) related donor: Bulsulfan+cyclophosphamid

(2) 2. unrelated donor: Fludarabine+Bulsulfan+cytarabine+anti-thymocyte cell globulin (ATG)

Eligibility

Sex/Gender

All

Age

18 Years to 55 Years

Inclusion criteria

Inclusion criteria: 1. The diagnosis of all the patients enrolled confirmed with bone marrow morphology, immunohistochemistry, immunologic phenotype and cytogenetics are acute myeloid leukemia (M0-M7, excluding M3 CR1), and <=CR2; 2. The chemotherapy regimen is based on DA, IA or MA, and consolidate with the original regimen for 2-4 cycles; 3. No Contraindication for hematopoietic stem cell transplant.

Exclusion criteria

Exclusion criteria: 1. Other severe physiologic or psychiatric disease impair patient's psychology status or efficiency of informed consent or the survival is less than 2 year; 2. uncontrolled chronic infections (including bacteria, fungus or virus), as cavity, otitis media, sinusitis. Transplant should be processed after the infections are controlled; 3. severe respiratory impairment; 4. a diabetes history with ketoacidosis predispose; 5. severe coagulation, embolus ventitis or lung embolism; 6. decompensatory liver dysfunction, active hepatitis; 7. severe autoimmune disease; 8. with thyroid dysfunction, and the function of thyroid can not be maintained at a normal level; 9. diagnosed with other malignancies within 5 years; 10. sever hypersusceptibility to biologic products (including antibiotics); 11. woman in labor; 12. not eligible for including criteria.

Design outcomes

Primary

Measure	Time frame
transplant-related Mortality at 100 days;2-year transplant-related Mortality;partial remission rate;2-year overall survival rate;Complete remission time;	—

Secondary

Measure	Time frame
2-year disease-free survival rate;	—

Countries

China

Contacts

Public ContactJianmin Wang

jmwang@medmail.com.cn+86 021 25074610

Outcome results

None listed

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