UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009762
Receipt number R000011438
Scientific Title Randomized phase II study of allogeneic hematopoietic stem cell transplantation for patients with myeloid malignancies using once daily intravenous busulfan and cyclophosphamide as conditioning regimen
Date of disclosure of the study information 2013/01/21
Last modified on 2018/10/31 16:46:58

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Basic information

Public title

Randomized phase II study of allogeneic hematopoietic stem cell transplantation for patients with myeloid malignancies using once daily intravenous busulfan and cyclophosphamide as conditioning regimen

Acronym

IVBU1001(BC): Randomized phase II study of once daily ivBu+Cy vs Cy+once daily ivBu

Scientific Title

Randomized phase II study of allogeneic hematopoietic stem cell transplantation for patients with myeloid malignancies using once daily intravenous busulfan and cyclophosphamide as conditioning regimen

Scientific Title:Acronym

IVBU1001(BC): Randomized phase II study of once daily ivBu+Cy vs Cy+once daily ivBu

Region

Japan


Condition

Condition

acute myeloid leukemia(AML)
myelodysplastic syndrome(MDS)
chronic myelogenous leukemia(CML)

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To investigate safety and efficacy of allogeneic hematopoietic stem cell transplantation using once daily intravenous busulfan(ivBu) and cyclophosphamide(Cy) as conditioning regimen for patients with AML, MDS and CML, with the comparison of order of application (ivBu+Cy vs Cy+ivBu) using randomized phase II trial design.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

Probability of event-free survival at 1 year after transplantation

Key secondary outcomes

(1) Incidence of Bearman's grade 2 or higher adverse events which occur from the begining of conditioning regimen to 28 days after transplantation
(2) Cumulative incidence of engraftment at 100 days after transplantation
(3) Cumulative incidence of non-relapse mortality at 100 days after transplantation
(4) Cumulative incidence of SOS(sinusoidal obstrction syndrome) at 100 days after transplantation
(5) Cumulative incidence of grade II-IV acute GVHD at 1 year after transplantation
(6) Cumulative incidence of chronic GVHD at 1 year after transplantation
(7) Probability of overall survival and cumulative incidence of relapse at 1 year after transplantation


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is considered as a block.

Blocking

YES

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Conditioning regimen
Intravenous busulfan 3.2mg/kg/day x 4days + Cyclophosphamide 60mg/kg/day x 2days

Interventions/Control_2

Conditioning regimen
Cyclophosphamide 60mg/kg/day x 2days + Intravenous busulfan 3.2mg/kg/day x 4days

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

16 years-old <=

Age-upper limit

55 years-old >

Gender

Male and Female

Key inclusion criteria

(1) Patients between the age of 16 and 55 at informed consent
(2) Patients diagnosed as AML, MDS, CML who are eigible for allogeneic hematopoietic stem cell transplantation. No limitation of disease status at transplantation. Patients who need chemotherapy for disease control except imatinib, dasatinib and nilotinib for CML are excluded
(3) Patients who have the fixed schedule about the harvest of bone marrow or paripheral blood stem cells from related or unrelated donors who meet the following conditions:
1) HLA-A, B, DRB1 are genetically identical
2) HLA-A and B are genetically identical and 1 locus of HLA-DRB1 is genetically mismatched
(4) Patients whose performance status are 0 or 1 by ECOG criteria
(5) Patients who meet all of the following conditions:
1) SPO2>=94% by room air
2) sCr=<1.5mg/dL
3) T-bil=<1.5mg/dL
4) AST, ALT and ganma-GTP=<3 x upper limit of normal range
5) Absence of abnormal findings of ECG which require therapeutic interventions
6) Ejection fraction of left ventricle>=50% by UCG
(6) Patients who give written informed consent following sufficient explanation. Patients who are under 20 years old are required to give informed consent from both persons with parental authority and patients themselves

Key exclusion criteria

(1) Patients with uncontrolled diabetes mellitus in spite of regular use of insulin
(2) Patients with uncontrolled hypertension in spite of use of antihypertensive drugs
(3) Patients who have active infection
(4) Patients who are positive for TPHA, HBV surface antigen or anti-HCV antibody
(5) Patients who are positive for anti-HTLV-I or anti-HIV antibody
(6) Patients who are not evaluated to be able to survive more than 100 days after transplantation
(7) Patients who have coinciding active malignancies
(8) Patients who are pregnant or in the lactation period, and who are not able to, or not willing to prevent conception during the therapeutic period of this clinical trial
(9) Patients who have psychiatric disorder
(10) Patients who have prior hematopoietic stem cell transplantation
(11) Patients who are considered as inappropriate to register by attending physicians

Target sample size

68


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takuya Yamashita

Organization

National Cacer Center Hospital

Division name

Hematopoietic Stem Cell Transplantation Division

Zip code


Address

5-1-1, Tsukiji, Chuo, Tokyo

TEL

+81-3-3542-2511

Email

tayamash@ncc.go.jp


Public contact

Name of contact person

1st name
Middle name
Last name Takuya Yamashita

Organization

National Cancer Center Hospital

Division name

Hematopoietic Stem Cell Transplantation Division

Zip code


Address

5-1-1, Tsukiji, Chuo, Tokyo

TEL

+81-3-3542-2511

Homepage URL


Email

tayamash@ncc.go.jp


Sponsor or person

Institute

Hematopoietic Stem Cell Transplantation Division, National Cancer Center Hospital

Institute

Department

Personal name



Funding Source

Organization

The Ministry of Health, Labor and Welfare

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


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

国立がん研究センター中央病院(東京都)


Other administrative information

Date of disclosure of the study information

2013 Year 01 Month 21 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

Completed

Date of protocol fixation

2012 Year 10 Month 03 Day

Date of IRB


Anticipated trial start date

2013 Year 01 Month 21 Day

Last follow-up date

2015 Year 04 Month 30 Day

Date of closure to data entry

2018 Year 03 Month 31 Day

Date trial data considered complete

2018 Year 03 Month 31 Day

Date analysis concluded

2019 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2013 Year 01 Month 12 Day

Last modified on

2018 Year 10 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011438


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name