Assessment of safety and effectiveness of once-daily administration of intravenous busulfan for allogeneic hematopoietic stem cell transplantatio
Phase 2
- Conditions
- Hematological diseases
- Registration Number
- JPRN-UMIN000015426
- Lead Sponsor
- Toranomon Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 10
Inclusion Criteria
Not provided
Exclusion Criteria
(1) Patients who have active malignant diseases other than hematological diseases (2) Patients who have poorly controlled psychiatric diseases (3) Patients who have active infection (4) Patients who have history of hypersensitivity against ivBu (5) Patients who are pregnant or suspected pregnancy, or are lactating (6) Patients who are considered to be not appropriate candidates for participation by attending physicians
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method (1) Incidence of survival and donor cell engraftment at day 100 post-transplant (2) Incidence of achieving complete donor type chimerism at day 100 post transplant (3) Event-free survival rate at day 365 post-transplant (4) Overall survival rate at day 365 post-transplant (5) Incidences of acute or chronic GVHD up to day 365 post-transplant
- Secondary Outcome Measures
Name Time Method (1) Incidence of adverse events up to day 100 post-transplant (2) Non-relapse mortality rate at day 100 post-transplant (3) Incidence of sinusoidal obstruction syndrome up to day 100 post-transplant (4) Rate of achieving optimal ivBu AUC (3,600-6,000micromolxmin/ml)