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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01177540
Registration number
NCT01177540
Ethics application status
Date submitted
5/08/2010
Date registered
9/08/2010
Date last updated
28/06/2022
Titles & IDs
Public title
Efficacy and Safety of Decitabine as Epigenetic Priming With Induction Chemotherapy in Pediatric Acute Myelogenous Leukemia (AML) Subjects
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Scientific title
A Randomized, Open Label, Multicenter Study to Evaluate the Efficacy and Safety of Decitabine as Epigenetic Priming With Induction Chemotherapy in Pediatric Acute Myelogenous Leukemia (AML) Subjects
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Secondary ID [1]
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E7373-G000-202
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pediatric Acute Myelogenous Leukemia (AML)
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Condition category
Condition code
Cancer
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Leukaemia - Acute leukaemia
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Cancer
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Leukaemia - Chronic leukaemia
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Cancer
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Children's - Leukaemia & Lymphoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Decitabine
Treatment: Drugs - Decitabine
Experimental: Arm A -
Experimental: Arm B -
Treatment: Drugs: Decitabine
5 day priming with decitabine followed by Induction Chemotherapy of ADE (daunorubicin, cytarabine, etoposide).
Treatment: Drugs: Decitabine
Induction Chemotherapy of ADE (daunorubicin, cytarabine, etoposide) only
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With Morphologic Complete Remission (CR)
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Assessment method [1]
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Disease response measurements were based on bone marrow evaluations (biopsies, aspirates, or both) performed by local pathology laboratories and assessed by study investigators. A designation of CR required that the participant achieve a morphologic leukemia-free state and have an absolute neutrophil count (ANC) greater than 1000 per microliter (/mcL) and a platelet count greater than 100,000/mcL.
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Timepoint [1]
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Day 50
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Secondary outcome [1]
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DNA Methylation
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Assessment method [1]
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Bone marrow samples were obtained at baseline and completion of induction therapy. DNA was extracted, and global DNA methylation was evaluated using the Infinium® Human Methylation450® BeadChip Array according to the manufacturer's protocol (Illumina, San Diego, California). Paired differential methylation analysis of end-induction marrows to participant matched screening marrows was performed to identify differentially methylated cytosines followed by guanine residue (CpG) loci (DML). A paired Wilcoxon rank test was conducted to compare end-induction marrows with diagnostic marrows within each arm to identify loci considered statistically significant and differentially methylated. Three different behaviors were defined: 'hypermethylation' (increased intensity in the tumor), 'hypomethylation' (decreased intensity in the tumor) and 'no change' (no substantial differences of intensity).
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Timepoint [1]
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Baseline up to completion of induction therapy (Day 15)
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Secondary outcome [2]
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Leukemia-free Survival (LFS)
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Assessment method [2]
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LFS was defined as time from CR until the recurrence of leukemia (greater than or equal to [>=] 5% bone marrow blasts, reappearance of peripheral blasts or the appearance of new dysplastic changes, or death, whichever occurred first). For participants who did not achieve a CR, LFS is set to zero days. For participants with CR who do not have leukemic recurrence or death, data for LFS was censored on the date of the last follow-up bone marrow or hematology examination, whichever is later. LFS was analyzed using Kaplan-Meier method.
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Timepoint [2]
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Baseline to recurrence of Leukemia or Death (up to 2 years 5 months)
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Secondary outcome [3]
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Overall Survival (OS)
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Assessment method [3]
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OS was defined as the time from the date of the first dose of study treatment to the date of death from any cause. OS was analyzed using Kaplan-Meier method.
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Timepoint [3]
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Baseline to Date of Death (up to 2 years 5 months)
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Secondary outcome [4]
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Percentage of Participants With Minimal Residual Disease (MRD) at Baseline and Day 50
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Assessment method [4]
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After induction chemotherapy, based on bone marrow biopsies. No formal statistical analyses of MRD were performed for this study.
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Timepoint [4]
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Baseline and Day 50
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Secondary outcome [5]
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Time to CR
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Assessment method [5]
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Disease response measurements were based on bone marrow evaluations (biopsies, aspirates, or both) performed by local pathology laboratories an assessed by study investigators. CR: requires that the participant achieved a morphologic leukemia-free state and had an ANC >1000/mcL and platelets >100,000/mcL. Hemoglobin concentration or hematocrit had no bearing on remission status, although the participant had to be independent of transfusions. Kaplan-Meier curves were used to describe time to CR.
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Timepoint [5]
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Randomization to Day 50
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Secondary outcome [6]
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Time to Neutrophil Recovery
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Assessment method [6]
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Blood sampling was used to determine recovery, and is defined as less than or equal to 1000 per cubic millimeter (/mm^3) for absolute neutrophil count (ANC). Summarized using Kaplan-Meier product limit estimators.
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Timepoint [6]
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Baseline up to Day 50
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Secondary outcome [7]
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Time to Platelet Recovery
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Assessment method [7]
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Blood sampling was used to determine recovery and is defined as less than or equal to 100,000/mm^3 for platelet count. Summarized using Kaplan-Meier product limit estimators.
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Timepoint [7]
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Baseline up to Day 38
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Eligibility
Key inclusion criteria
Inclusion Criteria
1. Males and females, age 1 to 16 years, inclusive
2. Females of childbearing potential must have a negative serum beta human chorionic
gonadotropin ( B-hCG) at Visit 1 (Screening) and a negative urine pregnancy test prior
to starting study drugs (Visit 2). Female subjects of childbearing potential must
agree to be abstinent or to use a highly effective method of contraception (eg, condom
+ spermicide, condom + diaphragm with spermicide, intrauterine devise (IUD), or have a
vasectomised partner) for at least one menstrual cycle prior to starting study drug(s)
and throughout the Randomization Phase or 30 days after the last dose of study drug.
Those females using hormonal contraceptives must also be using an additional approved
method of contraception (as described previously)
3. Sexually mature male patients who are not abstinent or have not undergone a successful
vasectomy, who are partners of women of childbearing potential must use, or their
partners must use a highly effective method of contraception (eg, condom + spermicide,
condom + diaphragm with spermicide, IUD) starting for at least one menstrual cycle
prior to starting study drug(s) and throughout the Randomization Phase and for 30 days
(longer if appropriate) after the last dose of study drug. Those with partners using
hormonal contraceptives must also be using an additional approved method of
contraception (as described previously)
4. Diagnosis of acute myelogenous leukemia ( AML) (bone marrow or peripheral blood blasts
greater than or equal to 20%)
5. Adequate cardiac function as defined by an echocardiogram or multiple gated
acquisition (MUGA) scan demonstrating an ejection fraction greater than 50%
6. Are willing and able to comply with all aspects of the protocol
7. Provide written informed consent from subject's guardian or legally authorized
representative and child assent (if applicable).
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Minimum age
1
Year
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Maximum age
16
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion Criteria
1. Females who are pregnant (positive B-hCG test) or lactating
2. History of chronic myelogenous leukemia (CML) [t(9;22)]
3. Acute promyelocytic leukemia (M3 subtype in French-American-British [FAB]
classification)
4. Known central nervous system (CNS) leukemia
5. AML associated with congenital syndromes such as Down syndrome, Fanconi anemia, Bloom
syndrome, Kostmann syndrome, or Diamond-Blackfan anemia
6. White blood cell (WBC) count greater than 100,000/mm3
7. Serum creatinine greater than 2.5 mg/dL
8. Alanine aminotransferase (ALT) greater than 5 x upper limit of normal (ULN) and/or
total bilirubin greater than 3 x ULN
9. Prior chemotherapy (other than hydroxyurea) or radiation therapy for AML
10. Known to be human immunodeficiency virus (HIV) positive
11. Any history of or concomitant medical condition that, in the opinion of the
Investigator, would compromise the subject's ability to safely complete the study
12. The Investigator believes the subject to be medically unfit to receive the study drug
or unsuitable for any other reason
13. Subject with hypersensitivity to decitabine, daunorubicin, cytarabine, or etoposide
14. Has participated in a drug trial in the last 4 weeks.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
3/03/2011
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
19/07/2013
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Sample size
Target
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Accrual to date
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Final
25
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Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
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Recruitment hospital [1]
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- New Lambton Heights
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Recruitment hospital [2]
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- Westmead
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Recruitment hospital [3]
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- Parkville
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Recruitment hospital [4]
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- Subiaco
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Recruitment postcode(s) [1]
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- New Lambton Heights
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Recruitment postcode(s) [2]
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- Westmead
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Recruitment postcode(s) [3]
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- Parkville
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Recruitment postcode(s) [4]
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- Subiaco
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Arizona
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Country [2]
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United States of America
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State/province [2]
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California
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Country [3]
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United States of America
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State/province [3]
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Colorado
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United States of America
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State/province [4]
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Florida
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Country [5]
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United States of America
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State/province [5]
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Georgia
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Country [6]
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United States of America
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State/province [6]
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Maryland
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Country [7]
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United States of America
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State/province [7]
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Massachusetts
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Country [8]
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United States of America
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State/province [8]
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Minnesota
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Country [9]
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United States of America
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State/province [9]
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New York
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Country [10]
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State/province [10]
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North Carolina
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Country [11]
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State/province [11]
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Ohio
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Country [12]
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United States of America
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State/province [12]
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Oregon
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Country [13]
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State/province [13]
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Texas
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Country [14]
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United States of America
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State/province [14]
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Utah
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Country [15]
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United States of America
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State/province [15]
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Washington
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Country [16]
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Canada
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State/province [16]
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Alberta
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Eisai Inc.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to provide data on the activity of a standard daunorubicin,
cytarabine, and etoposide (ADE) induction plus epigenetic priming with decitabine as assessed
by standard measures of complete remission (CR), leukemia free survival (LFS) and overall
survival (OS), as well as, on minimal residual disease (MRD). It will also provide necessary
data on the safety and Pharmacokinetics (PK) of decitabine in pediatric patients that is
currently unavailable.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01177540
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Eisai Medical Services
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Address
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Eisai Inc.
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Country
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Phone
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Fax
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Email
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Contact person for public queries
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01177540
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