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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000029275
Receipt No. R000033461
Scientific Title A pilot phase I study of azacitidine for the first relapsed patients with infant acute lymphoblastic leukemia and MLL gene rearrangement
Date of disclosure of the study information 2017/10/01
Last modified on 2017/10/25

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Basic information
Public title A pilot phase I study of azacitidine for the first relapsed patients with infant acute lymphoblastic leukemia and MLL gene rearrangement
Acronym AZA-MLL-P16
Scientific Title A pilot phase I study of azacitidine for the first relapsed patients with infant acute lymphoblastic leukemia and MLL gene rearrangement
Scientific Title:Acronym AZA-MLL-P16
Region
Japan

Condition
Condition Children with first relapsed infant MLL gene rearrangement positive acute lymphoblastic leukemia
Classification by specialty
Hematology and clinical oncology Pediatrics
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The primary aim of the study is to evaluate a safety of azacitidine (AZA) for children with relapsed infant MLL gene rearrangement positive acute lymphoblastic leukemia. An efficacy of AZA will be evaluated as a secondary aim.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase I

Assessment
Primary outcomes Occurrence rate of dose limiting toxicity (DLT)
Key secondary outcomes 1. Complete remission (CR) rate at the end of the test drug (AZA) administration.
2. CR rate at the end of the trial.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Either DL1 or DL0 would be given as a trial therapy.
DL1: AZA 2.5mg/kg/dose, 30min DIV, 7 days
DL0: AZA 2mg/kg/dose, 30min DIV, 7 days

Following 7-day of AZA, one course of chemotherapy selected by the physician will be given.
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
0 years-old <=
Age-upper limit
6 years-old >=
Gender Male and Female
Key inclusion criteria Patients should meet all the criteria listed below:
(1) Patients must be diagnosed as B-cell precursor acute lymphoblastic leukemia (ALL) with MLL gene rearrangement confirmed by FISH.
(2) Patients must be a first relapsed case.
(3) Patients must be less than 1 year old at the time of initial ALL diagnosis.
(4) Patients must be in complete remission following one course of standard induction chemotherapy for relapsed ALL.
(5) All patients' parents or legal guardians must sign a written informed consent.
(6) Patients must have performance score (PS) of 0 to 3.
(7) Patients' peripheral blood cell counts must meet the following criteria;
1. ANC 500/mcL or higher, after 48 hours or longer cessation of G-CSF.
2. Platelet count 50,000/mcL or higher, without platelet transfusion within 3 days.
(8) Patients must have sufficient organ function (liver, kidney, heart, lung) at the trial entry;
1. SpO2 96% or higher in room air, no abnormal findings in chest X-ray.
2. No abnormal ECG and UCG findings which require interventions.
3. AST and ALT value within 5 times of normal upper limit.
4. Serum bilirubin value within 2 times of normal upper limit.
5. Creatinine value within 2 times of normal upper limit.
Key exclusion criteria Patients should be excluded if either of the below criteria is met:
(1) Patients with uncontrollable infections.
(2) Patients with congenital heart disease which require any interventions.
(3) Patients with somatic chromosomal abnormalities.
(4) Patients with active hemorrhage at study entry.
(5) Patients with CNS symptoms at study entry.
(6) Patients with other malignant diseases.
(7) Patients with isolated extramedullary relapse.
(8) Patients with CNS relapse.
(9) Patients not eligible for the study entry decided by the primary/co-investigators of the study.
Target sample size 12

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Daisuke Tomizawa, M.D., Ph.D.
Organization National Center for Child Health and Development
Division name Children's Cancer Center
Zip code
Address 2-10-1 Okura, Setagaya-ku, Tokyo, Japan
TEL 03-3416-0181
Email tomizawa-d@ncchd.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Daisuke Tomizawa, M.D., Ph.D.
Organization National Center for Child Health and Development
Division name Children's Cancer Center
Zip code
Address 2-10-1 Okura, Setagaya-ku, Tokyo, Japan
TEL 03-3416-0181
Homepage URL
Email tomizawa-d@ncchd.go.jp

Sponsor
Institute National Center for Child Health and Development
Institute
Department

Funding Source
Organization A grant from National Center for Child Health and Development #27-4 "Studies on developing novel therapy for rare subtype of refractory leukemia.lymphoma in children"
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
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 国立研究開発法人 国立成育医療研究センター(東京都)

Other administrative information
Date of disclosure of the study information
2017 Year 10 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 Open public recruiting
Date of protocol fixation
2017 Year 09 Month 11 Day
Date of IRB
Anticipated trial start date
2017 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 09 Month 25 Day
Last modified on
2017 Year 10 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033461

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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