1. Acute lymphoblastic leukemia with or without Philadelphia chromosome: any CR or non-CR with marrow blasts <
Conditions
Interventions
Flu 30mg/m2x4days+Total body irradiaition(TBI)for conditioning. Dose escalation study every 6 doses from 8Gy of TBI.
Sponsors
Saitama Medical Center,Jichi Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Age: 55 to 65 years, or 18 to 55years not indicate for myeloablative conditioning due to complications such as past infection. 2.HLA matched or 1 Ag mismatched relate or unrelated donor. 3.ECOG 0-1 4.Cardiac: LV Ejection fraction>40% by Echocardiogram Pulmonary: SpO2>94 % and FEV1.0%>70%. Hepatic: total bilirubin>2.0 mg/dl and AST >2.5x ULN. Renal: Serum creatinine clearance >30 ml/min
Exclusion criteria
Exclusion criteria: Drug allergy used for conditioning or GvHD prophylaxis. Positive HBs antigen or seropositive to HIV. (Not exclude for seropositive to HCV) Uncontrolled infection. Patients inappropriate for transplantation with reasons other than above
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Non-hematological toxicities within 35days after HSCT(Phase I part). One-year disease free survival rate (PhaseII part). | — |
Secondary
| Measure | Time frame |
|---|---|
| Graft failure Regimen related toxicity (RRT) Acute GvHD incidence and severity Relapse Non relapse mortality | — |
Countries
Japan
Contacts
Public ContactKentaro Minagawa
Kobe University Hospital Department of General Medicine
Outcome results
None listed