Efficacy of Tiothepa in hematopoietic stem cell transplantation in acute lymphoblastic leukemia patients
Phase 2
Recruiting
- Conditions
- acute lymphoblastic leukemia.Acute lymphoblastic leukemia [ALL]C91.0
- Registration Number
- IRCT20140818018842N39
- Lead Sponsor
- Tehran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 31
Inclusion Criteria
patients with acute lymphoblastic leukemia
Exclusion Criteria
symptomatic coronary artery disease
karnofsky Performance Score < 60
patients with uncontrolled bacterial, viral or fungal infection
females who are pregnant or breastfeeding
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall survival. Timepoint: Monthly for 12 months after transplantation. Method of measurement: Visiting the patient and performing monthly lab tests in outpatient clinique.
- Secondary Outcome Measures
Name Time Method Relapse incidence. Timepoint: Monthly for 12 months after transplantation. Method of measurement: Visiting the patient in person and performing bone marrow biopsy and monthly lab tests in outpatient clinique.;Incidence of acute graft versus host disease. Timepoint: Monthly for 4 months after transplantation. Method of measurement: Visiting the patient in person and performing monthly lab tests in outpatient clinique.;Incidence of chronic graft versus host disease. Timepoint: Monthly for 12 months after transplantation. Method of measurement: Visiting the patient in person and performing monthly lab tests in outpatient clinique.;Transplant Related Mortality. Timepoint: Monthly for 12 months after transplantation. Method of measurement: Visiting the patient in person and performing monthly lab tests in outpatient clinique.