UMIN-CTR Clinical Trial

Public title

A phase I/II trial of HLA haploidentical peripheral blood stem cell transplantation following reduced-intensity conditioning

Acronym

A phase I/II trial of HLA haploidentical minitransplantation

Scientific Title

A phase I/II trial of HLA haploidentical peripheral blood stem cell transplantation following reduced-intensity conditioning

Scientific Title:Acronym

A phase I/II trial of HLA haploidentical minitransplantation

Region

Japan

Condition

Chronic myeloid leukemia, Acute myeloid leukemia, Acute lymphoid leukemia, Myelodysplastic syndrome, Malignant lymphoma

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate the safety and efficacy of HLA haploidentical peripheral blood stem cell transplantation following redeced-intensity conditioning for the patients with refractory hematological malignancies.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Phase I,II

Primary outcomes

Neutrophil engraftment within 35 days after transplantation (Phase I)
Overall survival at day 100 after transplantion (Phase II)

Key secondary outcomes

Incidence and severity of acute GVHD
Incidence and severity of chonic GVHD
Overall survival at 1 year after transplantation
Diase free survival at 1 year after transplantation
Treatment related mortality at 1 year after transplantation
Incidence and severity of infectious disease after transplantation
Immune reconstitution after transplantation

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Maneuver

Interventions/Control_1

HLA haploidentical peripheral blood stem cell transplantation following reduced-intensity conditioning

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

18

years-old

<=

Age-upper limit

60

years-old

>=

Gender

Male and Female

Key inclusion criteria

1) CML(2nd or later CP, AP, BC or relapse in non-CP state after allogeneic stem cell transplantation), AML(2nd or later CR, primary refractory or non-CR), ALL(2nd or later CR, primary refractory, non-CR or 1st CR in patients with Ph+ALL who could not achieve molecular remission), MDS/CMML(Int-II or high of the International Prognostic Scoring System, or relapse), Maglignant lymphoma (chemorefractory aggressive lymphoma)
2) Patients aged between 35 and 55 years. Patients aged between 18 and 35 years who are not eligible for myeloablative conditioning. 3) Written informed consent.
4) Unavailability of HLA-matched or -one antigen mismatched-related donor. Unavailability of HLA-matched or one allele mismatched-unrelated donor or needs urgent transplantation.
5) Availability of HLA-haploidentical family donor.
6) Performance status 0 or 1
7) Sufficient organ function

Key exclusion criteria

1) Allergy for the agents used in conditioning or GVHD prophylaxis
2) Positivity for HBs antigen and/or HIV antibody
3) Active lesions in CNS
4) Active infections
5) Patients who are considered as inappropriate with other reasons

Target sample size

25

Name of lead principal investigator

1st name
Middle name
Last name	Hiroyasu Ogawa

Organization

Hyogo College of Medicine

Division name

Division of Hematology, Department of Internal Medicine

Zip code

Address

1-1, Mukogawa-cho, Nishinomiya, Hyogo

TEL

0798-45-6886

Email

Name of contact person

1st name
Middle name
Last name	Satoshi Yoshihara

Organization

Hyogo College of Medicine

Division name

Division of Hematology, Department of Internal Medicine

Zip code

Address

1-1, Mukogawa-cho, Nishinomiya, Hyogo

TEL

0798-45-6886

Homepage URL

Email

haplo@hyo-med.ac.jp

Institute

Health and Labour Sciences Research Grants, Research on Human Genome, Tissue Engineering, Ministry of Health, Labour and Welfare

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Self funding

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

2005

Year

10

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

No longer recruiting

Date of protocol fixation

2005

Year

07

Month

01

Day

Date of IRB

Anticipated trial start date

2005

Year

10

Month

01

Day

Last follow-up date

2013

Year

04

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2005

Year

09

Month

30

Day

Last modified on

2012

Year

03

Month

30

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000319