UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001672
Receipt number R000002010
Scientific Title 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.
Date of disclosure of the study information 2009/01/31
Last modified on 2011/09/14 09:46:03

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Basic information

Public title

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.

Acronym

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

Scientific Title

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.

Scientific Title:Acronym

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

Region

Japan


Condition

Condition

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

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to investigate the efficacy of a combination of medium-dose VP-16, cyclophosphamide and total body irradiation as a conditioning regimen of allogeneic stem cell transplantation for acute lymphoblastic leukemia or acute biphenotypic leukemia.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

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

Key secondary outcomes

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


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

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).

Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

15 years-old <=

Age-upper limit

50 years-old >

Gender

Male and Female

Key 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

Key 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

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masahiro Imamura

Organization

Hokkaido University Graduate School of Medicine

Division name

Department of Hematology and Oncology

Zip code


Address

Kita-15 Nishi-7, Kita-ku, Sapporo, Hokkaido, Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Akio Shigematsu

Organization

Hokkaido University Graduate School of Medicine

Division name

Department of Hematology and Oncology

Zip code


Address

Kita-15 Nishi-7, Kita-ku, Sapporo, Hokkaido, Japan

TEL

011-706-7214

Homepage URL


Email

shigema@med.hokudai.ac.jp


Sponsor or person

Institute

Department of Hematology and Oncology, Hokkaido University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

The Grant-in-Aid for Cancer Research (19-1) from Ministry of Health, Labor and Welfare of Japan.

Organization

Division

Category of Funding Organization

Nationality of Funding Organization



Other related organizations

Co-sponsor

Center for Supporting Hematology-Oncology Trials

Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2009 Year 01 Month 31 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

No longer recruiting

Date of protocol fixation

2009 Year 01 Month 27 Day

Date of IRB


Anticipated trial start date

2009 Year 02 Month 01 Day

Last follow-up date

2015 Year 02 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2009 Year 01 Month 30 Day

Last modified on

2011 Year 09 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002010


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name