UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003648
Receipt number R000004409
Scientific Title A phase II study of allogeneic hematopoietic stem cell transplantation for patients with myeloid malignancies using intravenous busulfan and cyclophosphamide as conditioning regimen.
Date of disclosure of the study information 2010/06/15
Last modified on 2021/04/07 13:14:26

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Basic information

Public title

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

Acronym

KSGCT1002/C-SHOT1003

Scientific Title

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

Scientific Title:Acronym

KSGCT1002/C-SHOT1003

Region

Japan


Condition

Condition

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

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 intravenous busulfan and cyclophosphamide as conditioning regimen for patients with CML, AML and MDS.

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 within 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 obstruction 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

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

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

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

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 CML, AML, or MDS who are eligible 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 peripheral 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=<2.0mg/dL
3) T-bil=<1.5mg/dL
4) AST, ALT and r-GTP=<3 x upper limit of normal
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
(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

55


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shinichiro Okamoto, Miyamura Kouichi

Organization

Kanto Study Group for Cell Therapy(KSGCT)
Nagoya Blood and Marrow Transplantation (NBMT) Group

Division name

Chairman

Zip code


Address

Tokyo, Aichi

TEL

03-6225-2040

Email

ksgctdc@ksgct.net


Public contact

Name of contact person

1st name
Middle name
Last name Takuya Yamashita, Sawa Masashi

Organization

KSGCT, NBMTG

Division name

Study Coordinators

Zip code


Address

Tokyo

TEL

03-6225-2040

Homepage URL


Email

tayamash@ncc.go.jp


Sponsor or person

Institute

Kanto Study Group for Cell Therapy
Nagoya Blood and Marrow Transplantation (NBMT) Group

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Center for Supporting Hematology-Oncology Trial(C-SHOT)

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

2010 Year 06 Month 15 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications

https://link.springer.com/article/10.1007/s12185-020-02990-y

Number of participants that the trial has enrolled

40

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

2010 Year 05 Month 19 Day

Date of IRB


Anticipated trial start date

2010 Year 06 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2010 Year 05 Month 21 Day

Last modified on

2021 Year 04 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004409


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name