Reduced-intensity Conditioning Allogeneic Hematopoietic Cell Transplantation
NCT ID: NCT01252784
Last Updated: 2010-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
20 participants
OBSERVATIONAL
2010-11-30
2014-10-31
Brief Summary
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Detailed Description
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* Busulfan 3.2 mg/kg/d on d-7 to -6
* Fludarabine 30 mg/m2 on d-7 to -2
* ATG 1.5-3.0 mg/kg/d on d-3 to -1
* Methylpred 2 mg/kg/d on d-4 to -1
Mobilization and harvest
* Donor
* G-CSF 10 mcg/kg/d s.c. on d-3 to 0
* Harvest of PBMCs on d 0 to +1
Infuse G-PBMCs on d 0 to d+1.
* Donor G-PBMC infusion
GVHD prophylaxis
* Cyclosporine 1.5 mg/kg i.v. q 12 hrs beginning on d-1 and changed to oral dosing (with twice the i.v. dose) when oral intake is possible. Tapered beginning between d+30 and d+60.
* Methotrexate 15 mg/m2 i.v. on d+2, and 10 mg/m2 i.v. on d+4 and d+7
Prophylactic dose-escalating DLIs
* Begin at d+120 or at least 2 wks after IST discontinuation.
* No evidence of recurrence or GVHD CD3+ cell dose increment q 4 wks 4Three dose levels
Conditions
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* RAEB-1 or RAEB-2
* IPSS Intermediate-2 or High risk category
* Chronic myelomonocytic leukemia
2. Patients with appropriate hematopoietic cell donor
* HLA-matched sibling
* HLA-matched unrelated donor
* HLA-mismatched familial donor 3.16 years old or older
Exclusion Criteria
* Presence of uncontrolled bleeding
* Any coexisting major illness or organ failure
* Patients with psychiatric disorder or mental deficiency severe as to make compliance with the treatment unlike, and making informed consent impossible
16 Years
ALL
No
Sponsors
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Cooperative Study Group A for Hematology
NETWORK
Responsible Party
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Cooperative Study Group A for Hematology
Principal Investigators
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Je-Hwan Lee, Doctor
Role: PRINCIPAL_INVESTIGATOR
Asan Medical Center
Locations
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Asan Medical Center
Seoul, Asanbyeongwon-gil, Songpa-gu, South Korea
Countries
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Central Contacts
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Facility Contacts
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Yae-Eun Jang, nurse
Role: primary
Related Links
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Reduced-intensity conditioning allogeneic hematopoietic cell transplantation followed by prophylactic dose-escalating donor lymphocyte infusions in higher risk myelodysplastic syndrome
Other Identifiers
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Allo-039
Identifier Type: -
Identifier Source: org_study_id