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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) studied	Acute lymphoblastic leukeimia Acute biphenotypic leukemia (Acute leukemias of ambiguous lineage )
Date of first enrollment	2009/02/01
Target sample size	50
Countries of recruitment	Japan
Study type	Interventional
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).

TO Original Data: UMIN

Outcome(s)

Primary Outcome	Event-free survival at one year after transplantation (event: relapse or death)
Secondary Outcome	Overall 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

Primary Outcome

Event-free survival at one year after transplantation (event: relapse or death)

Secondary Outcome

Overall 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 minimum	15years-old
Age maximum	50years-old
Gender	Male and Female
Include criteria
Exclude criteria	1.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

Primary Sponsor	Department of Hematology and Oncology, Hokkaido University Graduate School of Medicine
Secondary Sponsor	Center for Supporting Hematology-Oncology Trials
Source(s) of Monetary Support	The Grant-in-Aid for Cancer Research (19-1) from Ministry of Health, Labor and Welfare of Japan.
Secondary ID(s)

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

TO Original Data: UMIN