NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000001672

Registered date:31/01/2009

A prospective clinical phase II study of allogeneic stem cell transplantation using conditioning regimen with medium-dose VP-16, cyclophosphamide and total-body irradiation for patients with acute lymphoblastic leukemia.

Basic Information

Recruitment status Complete: follow-up continuing
Health condition(s) or Problem(s) studiedAcute lymphoblastic leukeimia Acute biphenotypic leukemia (Acute leukemias of ambiguous lineage )
Date of first enrollment2009/02/01
Target sample size50
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Allogeneic stem cell transplantation for patients with acute lymphoblastic leukemia or acute biphenotypic leukemia following conditioning regimen of medium-dose VP, CY and TBI. This regimen consists of VP-16 (etoposide) at a dose of 15 mg/kg once daily on days -7 and -6 (total dose: 30 mg/kg) and CY at 60 mg/kg once daily on days -5 and -4 (total dose: 120 mg/kg) combined with fractionated TBI (total dose: 12 Gy).

Outcome(s)

Primary OutcomeEvent-free survival at one year after transplantation (event: relapse or death)
Secondary OutcomeOverall survival at one year and at two year after transplantation Event-free survival at one year after transplantation Non-relapse mortality at 100 days and at one year after transplantation Regimen-related toxicity Relapse rate at 100 days and at one year after transplantation Engraftment rate of neutrophil and platelet Incidence and severity of acute GVHD incidence and severity of chronic GVHD Incidence of infection Incidence of late complication and secondary malignancy Subclass analysis; donor, stem cell, age, Ph chromosome, disease status at transplantation, risk factors for ALL

Key inclusion & exclusion criteria

Age minimum15years-old
Age maximum50years-old
GenderMale and Female
Include criteria1. Diagnosis of either acute lymphoblastic leukemia or acute biphenotypic leukemia 2. Age between 15 and 50 years old 3. In complete remission 4. First stem cell transplantation 5. ECOG performance status 0-2 6. Intact organ function 7. Applicable stem cell (HLA-matched bone marrow or HLA-matched peripheral blood stem cell) 8. Written informed consent of participation
Exclude criteria1.ALL L3 (Burkitt leukemia) 2. Positivity for HBs antigen and/or HCV antibody and/or HIV antibody 3. Double cancers 4. Infection that need to be treated 5. Severe mental disorder 6. Pregnant or breast-feeding woman 7. Uncontrolled diabetes mellitus even by insulin treatment 8. Myocardial infarction or heart failure 9. Liver cirrhosis 10. Body mass index more than 35 11. Severe arrhythmia 12. Having pentostatin 13. Severe allergy for VP-16 or cyclophosphamide 14.An inappropriate patient judged by the medical attendant

Related Information

Contact

public contact
Name Akio Shigematsu
Address Kita-15 Nishi-7, Kita-ku, Sapporo, Hokkaido, Japan Japan
Telephone 011-706-7214
E-mail shigema@med.hokudai.ac.jp
Affiliation Hokkaido University Graduate School of Medicine Department of Hematology and Oncology
scientific contact
Name Masahiro Imamura
Address Kita-15 Nishi-7, Kita-ku, Sapporo, Hokkaido, Japan Japan
Telephone
E-mail
Affiliation Hokkaido University Graduate School of Medicine Department of Hematology and Oncology