Study of New RIC Regimen of BuFlu in Older and/or Intolerable Patients

The Study of New RIC Regimen of BuFlu in Older or Intolerable Patients With Hematologic Malignant Diseases

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01828619

Enrollment

Registered

2013-04-10

Start date

2013-02-28

Completion date

Unknown

Last updated

2013-04-10

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

Conditions

Leukemia, Myelodysplastic Syndrome

Keywords

Hematopoietic Stem Cell Transplantation, Busulfan, Fludarabine

Brief summary

The purpose of this study is to determine whether the new RIC regimen, containing of low dose of Bu (9.6mg/kg)and fludarabine without ATG, is suitable and effective in treating aged and/or intolerable patients with hematologic malignant disease, who undergoes allogenic stem cell transplantation.

Interventions

PROCEDUREmodified BuFlu conditioning

The regimen consisted of hydroxyurea 80 mg/kg on d -10; cytorabine 2 g/m2 on d -9; busulfan 3.2mg/kg/day iv. ×3days( on d -8 to -6); Flu30mg/m\^2 i.v.×5days(on d-6 to-2) and semustine 250 mg/m2 on d -3.

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

55 Years to 70 Years

Healthy volunteers

Inclusion criteria

* diagnosed of hematologic malignant disease * will undergo HLA matced HSCT * age \>=55years * \<55year and intolerable to standard myeloablative conditioning

Exclusion criteria

* KPS status \<70 * cardiac EF\<50% * creatine clearance \<50 ml/min * ALT more than 10 times of upper normal limit

Design outcomes

Primary

Measure	Time frame
stem cell engraftment	30day post transplantation

Secondary

Measure	Time frame
toxicity and treatment related mortality	100day and 1 year post transplantation

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026