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

Peking University

Status: Unknown

Conditions: Myelodysplastic Syndrome; Leukemia

Treatments: Procedure: modified BuFlu conditioning

Study type: Observational

Funder types: Other

Identifiers

NCT01828619

PKUIH-201303

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 55 to 70 years old

Volunteers: No 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

Trial design

60 participants in 1 patient group

modified BuFlu, HSCT, elder/intolerable

Description:

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.

Treatment:

Procedure: modified BuFlu conditioning