Allogeneic Intrabone marrow transplantation using bone marrow cells obtained by usual aspiration method: phase I/II study
Phase 1
Recruiting
- Conditions
- chronic myeloid leukemia, acute myeloid leukemia, acute lymphoid leukemia, myelodysplastic syndrome malignant lymphoma
- Registration Number
- JPRN-UMIN000007654
- Lead Sponsor
- Hyogo College of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 26
Inclusion Criteria
Not provided
Exclusion Criteria
1. Performance status: 2 or more in ECOG criteria 2. AST, ALT > 5 x normal limit 3. serum bilirubin level > 2.0 mg/dl 4. serum creatinine level > 2.0 mg/dl 5. SaO2 < 90% 6. Ejection fraction < 50% 7. HBs antigen(+), HIV antibody(+) 8. Active infection 9. presence of myelofibrosis
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary endpoint in the phase I study is the safety of intrabone marrow transplantation transplantation, and primary endpoint of the phase II study is donor-derived engraftment on day 35.
- Secondary Outcome Measures
Name Time Method