Unique ID issued by UMIN | UMIN000030767 |
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Receipt number | R000034502 |
Scientific Title | A study of haploidentical transplantation with post-transplant cyclophosphamide and prophylactic donor lymphocyte infusions. |
Date of disclosure of the study information | 2018/03/02 |
Last modified on | 2019/03/14 14:02:27 |
A study of haploidentical transplantation with post-transplant cyclophosphamide and prophylactic donor lymphocyte infusions.
A study of haploidentical transplantation with post-transplant cyclophosphamide and prophylactic donor lymphocyte infusions.
A study of haploidentical transplantation with post-transplant cyclophosphamide and prophylactic donor lymphocyte infusions.
A study of haploidentical transplantation with post-transplant cyclophosphamide and prophylactic donor lymphocyte infusions.
Japan |
AML,ALL,MDS,NHL,CML
Neuroblastoma,Rhabdomyosarcoma,Ewing sarcoma
Hematology and clinical oncology | Pediatrics |
Malignancy
NO
To investigate the safety and efficacy of HLA haploidentical hematopoietic stem cell transplantation using post transplant cyclophosphamide and prophylactic donor lymphocyte infusions.
Safety,Efficacy
treatment related mortality within 100days
1. overall survival, event free survival, relapse rate at 100 days
2. overall survival, event free survival, relapse rate at 1 year
3. neutrophilans platlet engraftment
4. engraftment failure
5. complete chimerism
6. acute GVHD
7. chronic GVHD
8. infectious event
9. grade 3-4 toxicity within 100 days
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
GVHD prophilaxis Cyclophosphamide 50mg/kg iv day3,4(or 5) and prophylactic donor lymphocyte infusions (day21,day35 and day60)
1 | months-old | <= |
192 | months-old | > |
Male and Female
1. patients who have hematologic malignancies or refractory childhood solid tumors and who are eligible for allogenic transplantation.
2. Age 0-15 years
3. 2nd CR or subsequent CR, nonCR. 1st CR as defined at least one of folloing: a) Acute lymphoblastic leukemia Intermediate or Poor risk as defined by NCCN guidelines
b) Acute Myelogenous Leukemia
Greater than 1 cycle of induction therapy required to achieve remission, Intedmediate or High risk as defined by NCCN guidelines
Monosomal karyotype ckit mutations with t(8;21), inv(16), t(16;16) t(7;11)(p15;p15)
Preceding myelodysplastic syndrome
c) Myelodysplastic syndrome
high, very high as defined by WHO classification-based Prognostic Scoring System
Patients who have receive ten units or more platelet transfusions per week, or two units or more RBC transfusions per month.
e) patients who have refractory or relapsed childhood solid tumors (neuroblastoma or rhabdmyosarcoma or Ewing sarcoma)
4. Patients who have no HLA-matched or 7/8 matched related donor.
5. Patients who have no HLA-matched or 7/8 matched unrelated donor.
6. Patients who given written informed consent to participate in the study.
1. Patients who are positive for HBs antigen, HCV antibody, or HIV antibody.
2. Patients with active other malignancies.
3. Women who are pregnant, of childbearing potential, or lactating.
4. Patients who experienced serious hypersensitivity or anaphylaxis to cyclophosphamide.
5. patients who are not eligble for this study at the discretion of the investigator.
8
1st name | |
Middle name | |
Last name | Akihiro Yachie |
Kanazawa University Hospital
Pediatrics
13-1, takaramachi, kanazawa, ishikawa
076-265-2313
pedialib@med.kanazawa-u.ac.jp
1st name | |
Middle name | |
Last name | Hideaki Maeba |
Kanazawa University Hospital
Pediatrics
13-1, takaramachi, kanazawa, ishikawa
076-265-2313
maebahideakijp@yahoo.co.jp
Department of Pediatrics, Kanazawa University Hospital
non
Other
NO
2018 | Year | 03 | Month | 02 | Day |
Unpublished
Terminated
2018 | Year | 01 | Month | 01 | Day |
2018 | Year | 01 | Month | 01 | Day |
2018 | Year | 01 | Month | 01 | Day |
2018 | Year | 12 | Month | 03 | Day |
2018 | Year | 12 | Month | 03 | Day |
2018 | Year | 12 | Month | 03 | Day |
2018 | Year | 12 | Month | 03 | Day |
2018 | Year | 01 | Month | 11 | Day |
2019 | Year | 03 | Month | 14 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034502
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