AML,ALL,MDS,NHL,CML Neuroblastoma,Rhabdomyosarcoma,Ewing sarcoma
Conditions
Interventions
GVHD prophilaxis Cyclophosphamide 50mg/kg iv day3,4(or 5) and prophylactic donor lymphocyte infusions (day21,day35 and day60)
Sponsors
Department of Pediatrics, Kanazawa University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| treatment related mortality within 100days | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactHideaki Maeba
Kanazawa University Hospital Pediatrics
Outcome results
None listed