UMIN-CTR Clinical Trial

Public title

A phase II study of Cord blood transplantation for elderly patients with myeloid malignancies using fludarabine and intravenous busulfan in addition to cytarabine and G-CSF.

Acronym

JSCT-FB13 CB

Scientific Title

A phase II study of Cord blood transplantation for elderly patients with myeloid malignancies using fludarabine and intravenous busulfan in addition to cytarabine and G-CSF.

Scientific Title:Acronym

JSCT-FB13 CB

Region

Japan

Condition

AML,MDS

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To investigate safety and efficacy of Cord blood transplantation using
180mg/m2 of fludarabine, 12.8mg/kg of intravenous busulfan, cytarabine and G-CSF for elderly patients aged 55-70 with AML or MDS.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Event-free survival at 1 year after transplantation

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Conditioning regimen:
G-CSF day-8--day2 200µg/m2+ Cytarabine day-7-day-4 100mg/m2+Flu 180mg/m2 + ivBu 12.8mg/kg + TBI 2Gy X 2

GVHD prophylaxis:
tacrolimus + oral mycophenolate mofetil (MMF)(30mg/kg/day in two divided doses, from day -1 to 30, and subsequently tapered and discontinued within 2 weeks, privided that there is no active GVHD requiring treatment)

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

Age-lower limit

55

years-old

<=

Age-upper limit

70

years-old

>=

Gender

Male and Female

Key inclusion criteria

1. Patients who have hematologic malignancies and who are eligible for allogeneic stem cell transplantation.
2. Age: 15-65 years old.
3. 2nd CR or subsequent CR, non CR.
1st CR as defined at least one of the following:
a) Acute lymphoblastic leukemia
Poor risk as defined by NCCN guidelines
b) Acute Myelogenous Leukemia
Greater than 1 cycle of induction therapy required to achieve remission
High risk as defined by NCCN guidelines
Monosomal karyotype
ckit mutations with t(8;21), inv(16), t(16;16)
t(7;11)(p15;p15)
Preceding myelodysplastic syndrome
c) Myelodysplastic syndrome
high, very high as defined by WHO classification-based Prognostic Scoring System
Patients who have receive ten units or more platelet transfusions per week, or two units or more RBC transfusions per month.
4.HLA matched or less than 3 antigen-mismatched CB with more than 2 X 10^7/kg nucleated cells.
5.ECOG PS:0-2
6.Those who have no severe organ dysfunction (T. Bil<2.0mg/ml, AST<=3 X upper limit of normal,ALT<=3 X upper limit of normal, Cr<2.0mg/dl, EF>50%, SpO2>95%)
7.Those who give written informed consent following sufficient explanation.
8.Those who are evaluated to be able to survive more than 3 months.

Key exclusion criteria

1.Those who are positive for anti-HIV antibody
2.Those who have history of gemtuzumab ozogamicin (MylotargTM) use within 4 months
3.Those who have coinciding active malignancies
4.Those who have uncontrolled psychiatric disorder
5.Those who have active infection
6.Those who have prior hematopoietic stem cell transplantation
7.Those who have history of chemotherapy within 30 days before transplant
8.Those who have hypersensitivity to drugs included in this protocol therapy
9.Those who are considered as inappropriate to register by attending physicians.

Target sample size

30

Name of lead principal investigator

1st name
Middle name
Last name	Naoya Uchida

Organization

Toranomon Hospital, Tokyo, Japan

Division name

Department of Hematology

Zip code

Address

2-2-2,Toranomonn,Minato-ku,Tokyo,Japan

TEL

Email

Name of contact person

1st name
Middle name
Last name

Organization

JSCT

Division name

FB13 datacenter

Zip code

Address

TEL

Homepage URL

Email

jsct-office@umin.ac.jp

Institute

JSCT

Institute

Department

Personal name

Organization

Resarch Foundation for Community Medicine

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2013

Year

05

Month

12

Day

URL releasing protocol

Publication of results

Published

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

Recruitment status

Main results already published

Date of protocol fixation

2013

Year

04

Month

27

Day

Date of IRB

Anticipated trial start date

2013

Year

05

Month

13

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

2017

Year

08

Month

26

Day

Other related information

Registered date

2013

Year

05

Month

12

Day

Last modified on

2018

Year

03

Month

21

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012504