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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000030767
Receipt No. 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

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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
Institute Department of Pediatrics, Kanazawa University Hospital
Institute
Department

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
URL(English) https://upload.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


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