UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007237 |
|---|---|
| Receipt number | R000008529 |
| Scientific Title | Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG) AML-D11:A Phase II Study to evaluate the feasibility and utility of minimal residual disease (MRD) for childhood acute myeloid leukemia with Down syndrome |
| Date of disclosure of the study information | 2012/03/01 |
| Last modified on | 2021/09/06 17:35:57 |
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Basic information
Public title
Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG) AML-D11:A Phase II Study to evaluate the feasibility and utility of minimal residual disease (MRD) for childhood acute myeloid leukemia with Down syndrome
Acronym
AML-D11
Scientific Title
Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG) AML-D11:A Phase II Study to evaluate the feasibility and utility of minimal residual disease (MRD) for childhood acute myeloid leukemia with Down syndrome
Scientific Title:Acronym
AML-D11
Region
| Japan |
Condition
Condition
Acute myeloid Leukemia
Myelodysplastic syndrome
Classification by specialty
| Hematology and clinical oncology | Pediatrics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the feasibility and utility of minimal residual disease (MRD) for childhood acute myeloid leukemia with Down syndrome
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Positive rate of MRD after induction therapy and at the end of chemotherapy
Key secondary outcomes
Evaluable rate of MRD
Positive rate of GATA1 mutation
Event free survival rate
Overall survival rate
Incidence of adverse events during chemotherapy
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Single common courses of remission induction multi-agent combination chemotherapy for all the eligible patients
For Standard Risk group(SR), 4 courses of intensification multi-agent combination chemotherapy
For High Risk group(HR), 2 courses of remission induction multi-agent combination chemotherapy followed by 4 courses of intensification multi-agent combination chemotherapy
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 | years-old | <= |
Age-upper limit
| 18 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)AML(excluding APL) and MDS with Down syndrome
2)age more than 4 month and less than 18 years old
3)ECOG performance status score of 0-3
4)no history of previous chemotherapy (except administration of cytarabine for transient myeloproliferative disorder) or radiotherapy
5)sufficient hepatic, renal, and cardiac function satisfying the laboratory data listed below:
T-Bil: within 3 times of the age-dependent normal range
serum creatinine value: within 3 times of the age-dependent normal range
ECG: no severe abnormalities (example; QTc >0.45)
6)written informed consent obtained from guardians
Key exclusion criteria
1)CNS hemorrhage which is likely to intervent protocol therapy
2)uncontrolled DM
3)uncontrolled cardiac failure
4)pregnancy
5)unmanageable infectious disease
6)history of congenital or acquired immunodeficiency
7)CNS leukemia
8)any inappropriate status judged by physician
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Taga |
Organization
Shiga University of Medical Science
Division name
Pediatrics
Zip code
520-2192
Address
Seta-tsukinowa, Otsu, Shiga, JAPAN
TEL
077-548-2228
ttaga@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Taga |
Organization
Shiga University of Medical Science
Division name
Pediatrics
Zip code
520-2192
Address
Seta-tsukinowa, Otsu, Shiga, JAPAN
TEL
077-548-2228
Homepage URL
http://www.jplsg.jp/
jplsgdata@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
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japan Pediatric Leukemia/Lymphoma Study Group
Address
San-nomaru4-1-1, Naka-ku, Nagoya, 460-0001
Tel
052-951-1111
jplsgdata@nnh.hosp.go.jp
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
UMIN000007237
Publication of results
Published
Result
URL related to results and publications
https://www.nature.com/articles/s41375-021-01157-w
Number of participants that the trial has enrolled
78
Results
To clarify a subgroup with high risk of relapse for Myeloid leukemia of Down syndrome (ML-DS), the role of minimal residual disease (MRD) was explored in the AML-D11 trial by the Japanese Pediatric Leukemia/Lymphoma Study Group. Three-year EFS and OS rates were 95.0% and 96.7% in the FCM-MRD-negative population, and both 98.1% in the GATA1-MRD-negative population. Detection of MRD by either FCM or GATA1 after initial induction therapy represents a significant prognostic factor for predicting ML-DS relapse.
Results date posted
| 2021 | Year | 09 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 02 | Month | 15 | Day |
Baseline Characteristics
Eligibility criteria for this study were as follows: 1) DS patients diagnosed with myeloid leukemia irrespective of blast percentage; 2) age >4 months and <18 years at diagnosis; 3) sufficient organ function (patients with cardiac disease were eligible unless serious complications were present); and 4) no history of previous chemotherapy.
Participant flow
Between March 2012 and February 2015, patients with ML-DS entered the AML-D11 study after informed consent was obtained from the guardians.
Adverse events
As grade 4 adverse events, sepsis was observed in 2 patients (2 events) during initial induction therapy and elevation of liver enzyme was observed in 1 patient (1 event) during the intensification phases. One toxic death due to cardiac failure was observed during remission, but no other severe cardiac sequelae were observed during follow-up. Secondary cancer was also not reported. The therapy-related mortality rate in this study was thus 1.3%.
Outcome measures
The primary endpoint was MRD positivity after induction and intensification therapy (TP-2, -3, -4, -S and -H). Secondary endpoints were evaluability of MRD, reasons for an unevaluable sample (e.g., dry tap), the proportion of patients with GATA1 mutation, event-free survival (EFS) rate, overall survival (OS) rate, and adverse events during induction and intensification therapy.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2012 | Year | 01 | Month | 27 | Day |
Date of IRB
| 2012 | Year | 01 | Month | 27 | Day |
Anticipated trial start date
| 2012 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
| 2018 | Year | 07 | Month | 13 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 02 | Month | 07 | Day |
Last modified on
| 2021 | Year | 09 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008529
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