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Clinical trial of Priming with Recombinant Human Granulocyte ColonyeStimulating Factor on low dose Decitabine combined with Busulfex and Cyclophosphamide for High-Risk Acute Myeloid Leukemia Patients Undergoing Human Leukocyte Antigene Matched Hematopoietic Stem Cell Transplantation

Effect of Priming with Recombinant Human Granulocyte ColonyeStimulating Factor on low dose Decitabine combined with Busulfex and Cyclophosphamide for High-Risk Acute Myeloid Leukemia Patients Undergoing Human Leukocyte Antigene Matched Hematopoietic Stem Cell Transplantation:A Multicenter,Open,Randomized controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-INR-16010071
Enrollment
Unknown
Registered
2016-12-02
Start date
2016-12-15
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

Test group:G-CSF 150ug qd -13d to -8d
Decitabine 20mg/m2 qd -12d to -8d, Bu 0.8mg/kg q6h d-7 to d-4, CTX 60mg/kg d-3 to d-2
Control group:Bu 0.8mg/kg q6h d-7 to d-4, CTX 60mg/kg d-3 to d-2

Sponsors

Xinqiao Hospital, Chongqing
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 60 Years

Inclusion criteria

Inclusion criteria: 1. Patients with high risk AML, no limit on the gender, aged60, Estimated lifetime>3months; 3. Patients have HLA matched donor; 4. No serious impairment of important organs; Cr55%, Hb>9g/dL, Bilirubin<2.0mg/dl; 5. No other contraindication of hematopoietic stem cell transplantation; 6. Voluntary participants, informed consent.

Exclusion criteria

Exclusion criteria: 1. Severe cardiac, renal or hepatic dysfunction; 2. Patients have other malignant cancer and must receive treatment; 3. Patients cant understand or follow study protocol due to clinical symptoms of brain dysfunction or serious mental illness; 4. Patients cant guarantee to accomplish treatment plan and follow-up; 5. Patients with severe acute hypersensitive reaction; 6. Uncontrolled active infection; 7. Patients who have been enrolled in other clinical trial; 8. Patients arent suitable for this clinical trial according to investigators judgement.

Design outcomes

Primary

MeasureTime frame
rate of relapse;

Secondary

MeasureTime frame
overall survival;Leukemia free survival;rate of acute graft versus host disease;rate of chronic graft versus host disease;rate of side effects;treatment related mortality;

Contacts

Public ContactXi Zhang

Xinqiao Hospital, Chongqing

zhangxxi@sina.com+86 13808310064

Outcome results

None listed

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