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

• Conditions: Leukemia; Myelodysplastic Syndrome
• Interventions: Procedure: modified BuFlu conditioning

• Registration Number: NCT01828619
• Lead Sponsor: Peking University People's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Status Verified: 2013-04
• Study First Submitted: 2013-04-07
• Study First Submitted QC: 2013-04-09
• Last Update Submitted: 2013-04-09
• Study First Posted: 2013-04-10
• Last Update Posted: 2013-04-10
• Primary Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
modified BuFlu, HSCT, elder/intolerable	modified BuFlu conditioning	The study group is the hematlogic malignant patients that older than 55years and/or with severe concurrent medical conditions, who will undergo HLA-matced allogenic HSCT to cure the disease. The patients will received a modified BuFlu conditioning.

Primary Outcome Measures

Name	Time	Method
stem cell engraftment	30day post transplantation

Secondary Outcome Measures

Name	Time	Method
toxicity and treatment related mortality	100day and 1 year post transplantation

Trial Locations

Locations (1)

Peking University People's Hospital; 🇨🇳 Beijing, China