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Allogeneic hematopoietic stem cell transplantation from HLA6/8-4/8 matched related donor for poor prognostic or refractory hematologic malignancy and solid tumor - Ibaraki Children's Hospital phase II study

Phase 2
Recruiting
Conditions
Acute leukemia, malignant lymphoma, and solid tumor
Registration Number
JPRN-UMIN000027010
Lead Sponsor
Ibaraki Children's Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
30
Inclusion Criteria

Not provided

Exclusion Criteria

(1)Germ line chromosomal abnormality other than trisomy 21 (2)Concurrent or prior malignant disease other than the original disease in interest or prior organ transplantation other than hematopoietic cell transplantation (3)Congenital or acquired immunodeficiency (4)Uncontrolled fungal, bacterial, or viral infection (including tuberculosis of HIV) (5)Pregnant, lactating, or highly suspected to be pregnant (6)Corrected QT interval by Fridericia, more than 0.45 second (7)Active hemorrhage in central nervous system, fulfilling grade more than 3 on CTCAE version 4.0 (8)Consciousness disturbance, score less than 14 on Glasgow Coma Scale (9)Obesity, by more than 30% of average weight for age. (10)Considered to be unsuitable for entry for the study

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Disease free survival rate at day 60 after transplantation
Secondary Outcome Measures
NameTimeMethod
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