UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000007390
Receipt No. R000008698
Scientific Title Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG) AML-R11: Multi-center Phase II Study of the efficacy and the safety in the induction chemotherapy containing fludarabine for children with the first bone marrow relapse and induction failure of acute myeloid leukemia.
Date of disclosure of the study information 2012/03/01
Last modified on 2015/09/29

* 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 Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG) AML-R11: Multi-center Phase II Study of the efficacy and the safety in the induction chemotherapy containing fludarabine for children with the first bone marrow relapse and induction failure of acute myeloid leukemia.
Acronym AML-R11
Scientific Title Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG) AML-R11: Multi-center Phase II Study of the efficacy and the safety in the induction chemotherapy containing fludarabine for children with the first bone marrow relapse and induction failure of acute myeloid leukemia.
Scientific Title:Acronym AML-R11
Region
Japan

Condition
Condition acute myeloid leukemia
Classification by specialty
Hematology and clinical oncology Pediatrics
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and the safety of the treatment regimen with FLAG and idarubicin as an induction therapy for the first bone marrow relapse and induction failure in children with acute myeloid leukemia
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Rate of bone marrow remission after the treatment regimen
Key secondary outcomes Positive rate of MRD by FACS after the treatment regimen
Two-year event free survival rate and over all survival rate
Rate of remission, two-year event free survival and over all survival between the first bone marrow relapse patients and induction failure patients
Rate of remission, two-year event free survival and over all survival among times of relapse and chromosomal abnormalities
Rate of adverse events (CTCAE ver.4.0, grade 3 or more)
Rate of accomplishment of the protocol
Rate of early death

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 Single course of combination chemotherapy consisted of G-CSF, fludarabine, cytosine arabinoside, and idarubicin is performed for all the eligible patients
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
2 years-old <=
Age-upper limit
20 years-old >
Gender Male and Female
Key inclusion criteria 1. AML (excluding AML with Down syndrome, APL, secondary AML, NK/myeloid leukemia, and granulocytic sarcoma)
2. the first bone marrow relapse (including extramedullary relapse at the same time) or induction failure
3. age less than 18 years old at diagnosis
4. age over than 1 years old and less than 20 years old at enrollment
5. ECOG performance status score :0-3
6. sufficient hepatic, renal and cardiac function satisfying the laboratory data listed below;
T. Bil. :less than 3 mg/dl
ALT: within 10X of the institutional normal range
serum creatinine value: less than 5 years old, less than 0.8mg/dl. 5-10 years old, less than 1.2 mg/dl. 10-20 years old, less than 1.5 mg/dl
ECG: no severe abnormalities (example; QTc 0.45 or more sec)
UCG: EF 50% or more, FS 25% or more, no finding of cardiac dysfunction
7. written informed consent obtained from guradians

Key exclusion criteria 1. isolated extramedullary relapse
2. history of allogeneic stem cell transplantation
3. history of FLAG therapy
4. any complication listed below;
active or unmanageable infectious disease, severe CNS bleeding(example; CTCAE Ver. 4.0; grade 3 or more, uncontrolled DM, severe mental abnormalities, heart diseases, hemophillia, autoimmune diseases
5. pregnancy
6. history of congenital or acquirede immunodeficiency
7. contraindication of cytosine arbinoside or idarubicin
8. administration of anti-cancer agent within 14 days of the enrollment
9. unusual treatment schedule or intermission in the first induction chemotherapy for AML because of personal request etc
10. any inappropriate status judged by physician
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideki Nakayama
Organization National Hospital Organization Fukuoka-Higashi Mediacal Center
Division name Department of Pediatrics
Zip code
Address 1-1-1 Chidori, Koga city, Fukuoka
TEL 092-943-2331
Email

Public contact
Name of contact person
1st name
Middle name
Last name Akiko Saito
Organization National Hospital Organization Nagoya Medical Center
Division name Clinical Research Center, Laboratory of Clinical, Epidemiological and Health
Zip code
Address 4-1-1, San-nomaru, Naka-ku, Nagoya city, Aichi
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

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)

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
2012 Year 03 Month 01 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
2011 Year 12 Month 07 Day
Date of IRB
Anticipated trial start date
2012 Year 03 Month 01 Day
Last follow-up date
2015 Year 11 Month 07 Day
Date of closure to data entry
2016 Year 02 Month 28 Day
Date trial data considered complete
2016 Year 02 Month 28 Day
Date analysis concluded
2016 Year 02 Month 28 Day

Other
Other related information

Management information
Registered date
2012 Year 02 Month 27 Day
Last modified on
2015 Year 09 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008698

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.