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.

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. - Allo-SCT using conditioning with medium-dose VP/CY/TBI for ALL (C-SHOT 0901)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001672

Enrollment

Registered

2009-01-31

Start date

2009-02-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute lymphoblastic leukeimia Acute biphenotypic leukemia (Acute leukemias of ambiguous lineage )

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. 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

Exclusion criteria

Exclusion 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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Japan

Contacts

Public ContactAkio Shigematsu

Hokkaido University Graduate School of Medicine Department of Hematology and Oncology

shigema@med.hokudai.ac.jp011-706-7214

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026