UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030767
Receipt number R000034502
Scientific Title A study of haploidentical transplantation with post-transplant cyclophosphamide and prophylactic donor lymphocyte infusions.
Date of disclosure of the study information 2018/03/02
Last modified on 2019/03/14 14:02:27

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

A study of haploidentical transplantation with post-transplant cyclophosphamide and prophylactic donor lymphocyte infusions.

Acronym

A study of haploidentical transplantation with post-transplant cyclophosphamide and prophylactic donor lymphocyte infusions.

Scientific Title

A study of haploidentical transplantation with post-transplant cyclophosphamide and prophylactic donor lymphocyte infusions.

Scientific Title:Acronym

A study of haploidentical transplantation with post-transplant cyclophosphamide and prophylactic donor lymphocyte infusions.

Region

Japan


Condition

Condition

AML,ALL,MDS,NHL,CML
Neuroblastoma,Rhabdomyosarcoma,Ewing sarcoma

Classification by specialty

Hematology and clinical oncology Pediatrics

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To investigate the safety and efficacy of HLA haploidentical hematopoietic stem cell transplantation using post transplant cyclophosphamide and prophylactic donor lymphocyte infusions.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

treatment related mortality within 100days

Key secondary outcomes

1. overall survival, event free survival, relapse rate at 100 days
2. overall survival, event free survival, relapse rate at 1 year
3. neutrophilans platlet engraftment
4. engraftment failure
5. complete chimerism
6. acute GVHD
7. chronic GVHD
8. infectious event
9. grade 3-4 toxicity within 100 days


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

GVHD prophilaxis Cyclophosphamide 50mg/kg iv day3,4(or 5) and prophylactic donor lymphocyte infusions (day21,day35 and day60)

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

1 months-old <=

Age-upper limit

192 months-old >

Gender

Male and Female

Key inclusion criteria

1. patients who have hematologic malignancies or refractory childhood solid tumors and who are eligible for allogenic transplantation.
2. Age 0-15 years
3. 2nd CR or subsequent CR, nonCR. 1st CR as defined at least one of folloing: a) Acute lymphoblastic leukemia Intermediate or Poor risk as defined by NCCN guidelines
b) Acute Myelogenous Leukemia
Greater than 1 cycle of induction therapy required to achieve remission, Intedmediate or 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.
e) patients who have refractory or relapsed childhood solid tumors (neuroblastoma or rhabdmyosarcoma or Ewing sarcoma)
4. Patients who have no HLA-matched or 7/8 matched related donor.
5. Patients who have no HLA-matched or 7/8 matched unrelated donor.
6. Patients who given written informed consent to participate in the study.

Key exclusion criteria

1. Patients who are positive for HBs antigen, HCV antibody, or HIV antibody.
2. Patients with active other malignancies.
3. Women who are pregnant, of childbearing potential, or lactating.
4. Patients who experienced serious hypersensitivity or anaphylaxis to cyclophosphamide.
5. patients who are not eligble for this study at the discretion of the investigator.

Target sample size

8


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Akihiro Yachie

Organization

Kanazawa University Hospital

Division name

Pediatrics

Zip code


Address

13-1, takaramachi, kanazawa, ishikawa

TEL

076-265-2313

Email

pedialib@med.kanazawa-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hideaki Maeba

Organization

Kanazawa University Hospital

Division name

Pediatrics

Zip code


Address

13-1, takaramachi, kanazawa, ishikawa

TEL

076-265-2313

Homepage URL


Email

maebahideakijp@yahoo.co.jp


Sponsor or person

Institute

Department of Pediatrics, Kanazawa University Hospital

Institute

Department

Personal name



Funding Source

Organization

non

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



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



Other administrative information

Date of disclosure of the study information

2018 Year 03 Month 02 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

Terminated

Date of protocol fixation

2018 Year 01 Month 01 Day

Date of IRB

2018 Year 01 Month 01 Day

Anticipated trial start date

2018 Year 01 Month 01 Day

Last follow-up date

2018 Year 12 Month 03 Day

Date of closure to data entry

2018 Year 12 Month 03 Day

Date trial data considered complete

2018 Year 12 Month 03 Day

Date analysis concluded

2018 Year 12 Month 03 Day


Other

Other related information



Management information

Registered date

2018 Year 01 Month 11 Day

Last modified on

2019 Year 03 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034502


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name