JPRN-jRCTs041180059
Recruiting
Phase 3
A randomized control trial of conditioning regimen of cord blood transplantation for adult myeloid malignancies comparing CA/CY/TBI with vs without G-CSF priming - G-CONCORD
Terakura Seitaro0 sites108 target enrollmentFebruary 28, 2019
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Acute myelogenous leukemia or myelodysplastic syndrome
- Sponsor
- Terakura Seitaro
- Enrollment
- 108
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.First stem cell transplantation including autologous or allogeneic.
- •2\.Hematological disease listed below.
- •\-Acute myelogenous leukemia
- •\-Myelodysplastic syndrome, RAEB\-1 or RAEB\-2\. Either intermediate\-II or high in IPSS. High or very\-high in WPSS. Relapsed after CR.
- •3\.Obtained informed consent
- •4\.Performance status 0,1,2
- •5\.appropriate cord blood is available
- •6\.appropriate organ function
Exclusion Criteria
- •1\.HBs antigen positive
- •2\.HCV antibody positive
- •3\.HIV antibody positive
- •4 Donor\-specific anti\-HLA antibody positive
- •5\.Use of gemtuzumab ozogamicin within 6 months before transplantation
- •6\.During pregnant or breast\-feeding
- •7\. Uncontrollable psychiatric disorder
- •8\. Uncontrollable infection
- •9\. Allergy for any drug used in the conditioning regimen or GVHD\-prophylaxis
- •10\.Considered to be unfit for the study enrollment by the physician
Outcomes
Primary Outcomes
Not specified
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