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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000005936
Receipt No. R000007016
Official scientific title of the study Phase II study of allogeneic hematopoietic stem cell transplantation using a preparative regimens consisting of iv Bu + Flu + L-PAM for patients with juvenile myelomonocytic leukemia (JMML)
Date of disclosure of the study information 2011/07/07
Last modified on 2011/07/07

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Basic information
Official scientific title of the study Phase II study of allogeneic hematopoietic stem cell transplantation using a preparative regimens consisting of iv Bu + Flu + L-PAM for patients with juvenile myelomonocytic leukemia (JMML)
Title of the study (Brief title) JMML-11
Region
Japan

Condition
Condition Juvenile myelomonocytic leukemia (JMML)
Classification by specialty
Pediatrics
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and the efficacy of allogeneic hematopoietic stem cell transplantation using a preparative regimen consisting of iv Bu + Flu + L-PAM for patients with newly diagnosed juvenile myelomonocytic leukemia (JMML).
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Event-free survival 1 year after stem cell transplantation
Key secondary outcomes Safety of the regimen.
The adverse events and the efficacy of GVHD (acute/chronic)
Overall survival 3 years after stem cell transplantation
Event-free survival 3 years after stem cell transplantation
Non-relapse mortality within 100 days after stem cell transplantation
The rate of late effects after stem cell transplantation
The effect of individualized iv Bu dose modification on the engraftment rate and adverse event rate
The effect of chimerism assays on engraftment rate and adverse event rate within 100 days after stem cell transplantation
To elucidate the efficacy of MRD assessment using DNA mutation status of PTPN11 or RAS on relapse rate, eFS at 1 year and 3 years after stem cell transplantation.
Engraftment rate 100 days after stem cell transplantation

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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 The effect of allogeneic hematopoietic stem cell transplantation assessing event-free survival 1 year after transplantation.
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
1 years-old <=
Age-upper limit
14 years-old >=
Gender Male and Female
Key inclusion criteria Diagnosis of JMML, that was confirmed by the pathological central review conducted by the MDS Committee of the Japanese Society of Pediatric Hematology.
Diagnosis between 6 months old and 14 years old.
No previous treatment including unaccepted chemotherapy, radiotherapy and allogeneic hematopoietic stem cell transplantation.
Adequate end organ function.
ECOG performance status score should be 0-2.
Total bilirubin less than 2mg/dl, creatinin below the upper normal limit defined according to the age, creatinin clearance (or cystatin) within normal range.
Normal EKG.
Ejection fraction of left ventricle more than 50%.
Saturation of oxygen more than 95%.
Legal guardians must sign an informed consent and have been told of its possible benefits and toxic side effects.
An adequate donor is available.
Key exclusion criteria Diagnosis of Noonan syndrome, disorders with germline RAS mutations and ALPS-like diseases with somatic RAS mutations.
Intracranial hemorrhage.
Heart failure requiring treatment.
Chronic renal failure.
Active uncontrolled infections.
Uncontrolled diabetes mellitus.
Liver cirrhosis.
Psychiatric problems.
Target sample size 43

Research contact person
Name of lead principal investigator Atsushi Manabe
Organization St. Luke's International Hospital
Division name department of Pediatrics
Address 9-1, Akashi-cho, Chuo-ku, Tokyo, 104-8560
TEL 03-3541-5151
Email

Public contact
Name of contact person Akiko Saito
Organization NPO-OSCR
Division name Data Center
Address National Nagoya Hospital, 4-1-1, San-nomaru, Naka-ku, Nagoya
TEL 052-951-1111
Homepage URL http://www.jplsg.jp/
Email officejp@nnh.hosp.go.jp

Sponsor
Institute Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG)
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

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
2011 Year 07 Month 07 Day

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2011 Year 07 Month 01 Day
Anticipated trial start date
2011 Year 07 Month 01 Day
Last follow-up date
2018 Year 05 Month 01 Day
Date of closure to data entry
2018 Year 05 Month 01 Day
Date trial data considered complete
2018 Year 05 Month 01 Day
Date analysis concluded
2018 Year 05 Month 01 Day

Related information
URL releasing protocol http://www.jplsg.jp/
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2011 Year 07 Month 06 Day
Last modified on
2011 Year 07 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007016


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