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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Secondary ID [1] 0 0
E7373-G000-202
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pediatric Acute Myelogenous Leukemia (AML) 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Morphologic Complete Remission (CR)
Timepoint [1] 0 0
Day 50
Secondary outcome [1] 0 0
DNA Methylation
Timepoint [1] 0 0
Baseline up to completion of induction therapy (Day 15)
Secondary outcome [2] 0 0
Leukemia-free Survival (LFS)
Timepoint [2] 0 0
Baseline to recurrence of Leukemia or Death (up to 2 years 5 months)
Secondary outcome [3] 0 0
Overall Survival (OS)
Timepoint [3] 0 0
Baseline to Date of Death (up to 2 years 5 months)
Secondary outcome [4] 0 0
Percentage of Participants With Minimal Residual Disease (MRD) at Baseline and Day 50
Timepoint [4] 0 0
Baseline and Day 50
Secondary outcome [5] 0 0
Time to CR
Timepoint [5] 0 0
Randomization to Day 50
Secondary outcome [6] 0 0
Time to Neutrophil Recovery
Timepoint [6] 0 0
Baseline up to Day 50
Secondary outcome [7] 0 0
Time to Platelet Recovery
Timepoint [7] 0 0
Baseline up to Day 38

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).
Minimum age
1 Year
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/03/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
19/07/2013
Sample size
Target
Accrual to date
Final
25
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
- New Lambton Heights
Recruitment hospital [2] 0 0
- Westmead
Recruitment hospital [3] 0 0
- Parkville
Recruitment hospital [4] 0 0
- Subiaco
Recruitment postcode(s) [1] 0 0
- New Lambton Heights
Recruitment postcode(s) [2] 0 0
- Westmead
Recruitment postcode(s) [3] 0 0
- Parkville
Recruitment postcode(s) [4] 0 0
- Subiaco
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Maryland
Country [7] 0 0
United States of America
State/province [7] 0 0
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
Minnesota
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
North Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Ohio
Country [12] 0 0
United States of America
State/province [12] 0 0
Oregon
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
United States of America
State/province [14] 0 0
Utah
Country [15] 0 0
United States of America
State/province [15] 0 0
Washington
Country [16] 0 0
Canada
State/province [16] 0 0
Alberta

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eisai Inc.
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT01177540
Trial related presentations / publications
Gore L, Triche TJ Jr, Farrar JE, Wai D, Legendre C, Gooden GC, Liang WS, Carpten J, Lee D, Alvaro F, Macy ME, Arndt C, Barnette P, Cooper T, Martin L, Narendran A, Pollard J, Meshinchi S, Boklan J, Arceci RJ, Salhia B. A multicenter, randomized study of decitabine as epigenetic priming with induction chemotherapy in children with AML. Clin Epigenetics. 2017 Oct 5;9:108. doi: 10.1186/s13148-017-0411-x. eCollection 2017.
Public notes

Contacts
Principal investigator
Name 0 0
Eisai Medical Services
Address 0 0
Eisai Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01177540