UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007390 |
|---|---|
| Receipt number | 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 11:50:06 |
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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
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
officejp@nnh.hosp.go.jp
Sponsor or person
Institute
Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008698
