Acute leukemia
Conditions
Interventions
Conditioning regime without cyclophosphamide Stem cell transplantation at day 0 Cyclophosphamide 50mg/kg at days 3, 4
Sponsors
National Center for Child Health and Development
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Diagnosed as acute leukemia (acute lymphoblastic leukemia/acute myeloblastic leukemia), or lymphoma 2) First or second remission, and planned to have stem cell transplantation 3) Donor for transplantation is one of the follows; a. HLA 6/6 (A, B, DR) matched related donor b. HLA 5/6 (A, B, DR) matched related donor c. HLA 6/6 (A, B, DR) matched unrelated donor 4) Age at transplantation <20 years 5) ECOG Performance status: 0-2 6) Sufficient organ function, as follows; a. T-Bil <= 1.5 mg/dl b. Serum creatinine <= 0.8 mg/dl (age <5y), <= 1.2 mg/dl (age 5-9y), <= 1.5 mg/dl (10y or older) c. Ejection fraction 45% or better, and QTfc <0.45 sec 7) Obtained informed consent from a guardian of the patient
Exclusion criteria
Exclusion criteria: 1. Prior allogeneic stem cell transplantation 2. Effusion with grade 2 or worse at CTCAE ver 4.0 3. Uncontrolled infection 4. Severe psychological disorders 5. Pregnant or suspected pregnancy 6. Not eligible for this study at the discretion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of graft-versus-host disease at day 100 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Engraftment probability at day 30 2. Non-relapse mortality at day 100 3. Incidence of infectious disease at week 8 4. Reconstruction of immune status 5. Time from transplantation to onset of chronic GVHD 6. Time from transplantation to relapse 7. Time from transplantation to death | — |
Countries
Japan
Contacts
Public ContactMotohiro Kato
National Center for Child Health and Development Children's Cancer Center
Outcome results
None listed