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

Peking University People's Hospital60 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Leukemia Myelodysplastic Syndrome

Interventions

modified BuFlu conditioningPROCEDURE

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.

Eligibility

Sex: ALLMin age: 55 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Peking University People's Hospital

Beijing, China

Outcomes

Primary Outcomes

stem cell engraftment

Time frame: 30day post transplantation

Secondary Outcomes

toxicity and treatment related mortality

Time frame: 100day and 1 year post transplantation

Data from ClinicalTrials.gov

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