UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029947
Receipt number R000034144
Scientific Title A randomized control trial of conditioning regimen of cord blood transplantation for adult myeloid malignancies comparing CA/CY/TBI with vs without G-CSF priming
Date of disclosure of the study information 2018/02/01
Last modified on 2022/05/30 17:45:12

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Basic information

Public title

A randomized control trial of conditioning regimen of cord blood transplantation for adult myeloid malignancies comparing CA/CY/TBI with vs without G-CSF priming

Acronym

CBT-P3 study comparing CA/CY/TBI with vs without G-CSF priming

Scientific Title

A randomized control trial of conditioning regimen of cord blood transplantation for adult myeloid malignancies comparing CA/CY/TBI with vs without G-CSF priming

Scientific Title:Acronym

CBT-P3 study comparing CA/CY/TBI with vs without G-CSF priming

Region

Japan


Condition

Condition

Myelogenous Hematological Malignancies

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To investigate the efficacy of granulocyte-colony-stimulating factor use with conditioning regimen for umbilical cord blood transplantation for adult myelogenous hematological malignancy patient. Conditioning regimen consists of a combination of cytarabine, cyclophosphamide, and total body irradiation.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Phase III


Assessment

Primary outcomes

2-year disease-free survival

Key secondary outcomes

1) Time to hematopoietic recovery
2) Engraftment rate
3) Treatment-related toxicity until day 28
4) Mucosal toxicity grade until day 42 (maximum grade and incidence)
5) Maximum dose of narcotic drug per day until day 42
6) Incidence and severity of acute GVHD
7) Incidence and severity of chronic GVHD
8) Treatment-related mortality at day 100 and 2 years after transplantation
9) Relapse rate at 2 years after transplantation
10) Overall survival (OS) at 2 years after transplantation
11) Incidence of infectious event (causative bacteria or other microorganisms, site of infection, day of onset, frequency)
12) Causes of deaths


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

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

To add G-CSF priming to the conditioning regimen concomittantly with two days of Ara-C.

Interventions/Control_2

Not to add G-CSF to the conditioning regimen.

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.First stem cell transplantation including autologous or allogeneic.
2.Hematological disease listed below.
-Acute myelogenous leukemia
-Myelodysplastic syndrome, RAEB-1 or RAEB-2. Either intemediate-II or high in IPSS. High or very-high in WPSS. Relapsed after CR.
3.Obtained informed consent
4.Performance status 0,1,2
5.appropriate cord blood is available
6.appropriate organ function

Key exclusion criteria

1.HBs antigen positive
2.HCV antibody positive
3.HIV antibody positive
4 Donor-specific anti-HLA antibody positive
5.Use of gemtuzumab ozogamicin within 6 months before transplantation
6.During pregnant or breast-feeding
7. Uncontrollable psychiatric disorder
8. Uncontrollable infection
9. Allergy for any drug used in the conditioning regimen or GVHD-prophylaxis
10.Considered to be unfit for the study enrollment by the physician

Target sample size

160


Research contact person

Name of lead principal investigator

1st name Seitaro
Middle name
Last name Terakura

Organization

Nagoya University Hospital

Division name

Deapartment of Hematology

Zip code

466-8560

Address

65 Tsurumai, Showa-ku, Nagoya, Aichi, Japan

TEL

052-744-2145

Email

tseit@med.nagoya-u.ac.jp


Public contact

Name of contact person

1st name Seitaro
Middle name
Last name Terakura

Organization

Nagoya University Hospital

Division name

Department of Hematology

Zip code

466-8560

Address

65 Tsurumai, Showa-ku, Nagoya, Aichi, Japan

TEL

052-744-2145

Homepage URL


Email

tseit@med.nagoya-u.ac.jp


Sponsor or person

Institute

Japan Agency for Medical Research and Development

Institute

Department

Personal name



Funding Source

Organization

Japan Agency for Medical Research and Development

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Nagoya University Certified Review Board

Address

65 Tsurumai-cho, Showa-ku, Nagoya, Aichi

Tel

052-744-2947

Email

ethics@med.nagoya-u.ac.jp


Secondary IDs

Secondary IDs

YES

Study ID_1

jRCTs041180059

Org. issuing International ID_1

Ministry of Health, Labour and Welfare

Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2018 Year 02 Month 01 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

2017 Year 11 Month 15 Day

Date of IRB

2018 Year 01 Month 11 Day

Anticipated trial start date

2018 Year 01 Month 15 Day

Last follow-up date

2024 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 11 Month 13 Day

Last modified on

2022 Year 05 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034144


Research Plan
Registered date File name
2023/05/19 CBT-P3_protocol_3.1.1_20221219.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name