Acute Myelogenous Leukemia (AML)Phase 2NCT00943553
A Randomized Study of Epigenetic Priming Using Decitabine With Front Line Induction Chemotherapy Compared With Immediate Induction Chemotherapy in Pediatric Acute Myelogenous Leukemia (AML) Subjects
A Phase 2 study testing decitabine Induction Chemotherapy and Induction Chemotherapy in people with Acute Myelogenous Leukemia (AML), run by Eisai Inc. at 1 site in India.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of decitabine when used before chemotherapy to treat leukemia in pediatric patients. The study will also evaluate the ways decitabine is affected or changed when used in the human body. Read more about this study
- Who is it for?
- Ages 1 year to 16 years
- Conditions the study is for
- Acute Myelogenous Leukemia (AML)
- What is being tested?
- decitabine Induction Chemotherapy and Induction Chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteIndia
- Study dates
- Jun 2010to Aug 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Males and females, age 1 to16 years, inclusive
- Females of childbearing potential must have a negative serum beta human chorionic gonadotropin (β-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 longer of either Core Study period 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).
- 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 entire study period 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).
- Diagnosis of acute myelogenous leukemia (AML)(bone marrow or peripheral blood blasts ≥ 20%)
- Adequate cardiac function as defined by an echocardiogram or multiple gated acquisition (MUGA) scan demonstrating an ejection fraction within normal limits
- Are willing and able to comply with all aspects of the protocol
- Provide written informed consent from subject's guardian or legally authorized representative and child assent (if applicable)
Who cannot join
- Females who are pregnant (positive β-hCG test) or lactating
- History of chronic myelogenous leukemia (CML) [t(9;22)]
- Acute promyelocytic leukemia (M3 subtype in French-American-British [FAB] classification).
- Known central nervous system (CNS) leukemia
- AML associated with congenital syndromes such as Down syndrome, Fanconi anemia, Bloom syndrome, Kostmann syndrome, or Diamond Blackfan anemia
- White blood cell (WBC) count > 40,000/mm3
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- Serum creatinine > 2.5 mg/dL
- Alanine aminotransferase (ALT) > 5 x upper limit of normal (ULN) and/or total bilirubin > 3 x ULN
- Prior chemotherapy (other than hydroxyurea) or radiation therapy for AML
- Known to be human immunodeficiency virus (HIV) positive
- 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
- The Investigator believes the subject to be medically unfit to receive the study drug or unsuitable for any other reason.
- Subject with hypersensitivity to decitabine, daunorubicin, or cytarabine
- Has participated in a drug trial in the last 4 weeks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Study of Epigenetic Priming Using Decitabine With Front Line Induction Chemotherapy Compared With Immediate Induction Chemotherapy in Pediatric Acute Myelogenous Leukemia (AML) Subjects.
The purpose of this study is to evaluate the efficacy and safety of decitabine when used before chemotherapy to treat leukemia in pediatric patients. The study will also evaluate the ways decitabine is affected or changed when used in the human body.
- Conditions
- Acute Myelogenous Leukemia (AML)
- Being tested
- decitabine Induction Chemotherapy, Induction Chemotherapy
- Keywords
- AML
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
decitabine Induction ChemotherapyDrug
Also called E7373
Arm A - 12 days (5 days of intravenous (IV) decitabine 20 mg/m^2 followed by 7 days of induction chemotherapy with IV daunorubicin 45 mg/m^2 and cytarabine 100 mg/m^2/day)
Induction ChemotherapyDrug
Also called E7373
Arm B - 7 days (7 days of induction chemotherapy with IV daunorubicin 45 mg/m^2 and cytarabine 100 mg/m^2/day only)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: decitabine Induction Chemotherapy |
| 2 | Experimental | Not described Receives: Drug: Induction Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Endpoint (Core Component): Complete Remission (CR) Rate as defined by International Working Group - 2003 criteria
Measured: ~ 2 years
Secondary outcomes (2)
Secondary Endpoint (Core Component): Methylation of DNA following decitabine therapy.
Measured: Until Week 3 after chemotherapy
Secondary Endpoint (Core Component): Time to platelet recovery (≥ 100,000/mm3) and time to neutrophil recovery (absolute neutrophil count [ANC] ≥ 1000/mm3) following induction chemotherapy
Measured: Until ~ 4 weeks after last dose of induction chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2009 (estimated)
- Study startJun 2010
- Primary completionAug 2011
Why it stopped: Terminated by Sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myelogenous Leukemia (AML)Studies of the same condition, open and under way.
- More trials run by Eisai Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Tarassoff, MD, Study director, Eisai Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00943553
- Sponsor's protocol ID
- E7373-G000-201
- Status last verified
- Apr 2015
- First submitted
- 21 Jul 2009
- Last updated
- 13 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study of Epigenetic Priming Using Decitabine With Front Line Induction Chemotherapy Compared With Immediate Induction Chemotherapy in Pediatric Acute Myelogenous Leukemia (AML) Subjects.
- ClinicalTrials.gov ID
- NCT00943553
- Acronym / sponsor ID
- E7373-G000-201
- Conditions
- Acute Myelogenous Leukemia (AML)
- Keywords
- AML
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Terminated by Sponsor
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Aug 2011 (actual)
- First posted
- 22 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy and safety of decitabine when used before chemotherapy to treat leukemia in pediatric patients. The study will also evaluate the ways decitabine is affected or changed when used in the human body.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: decitabine Induction Chemotherapy |
| 2 | Experimental | Drug: Induction Chemotherapy |
Who may qualify
- Ages
- 1 year to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Males and females, age 1 to16 years, inclusive
- Females of childbearing potential must have a negative serum beta human chorionic gonadotropin (β-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 longer of either Core Study period 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).
- 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 entire study period 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).
- Diagnosis of acute myelogenous leukemia (AML)(bone marrow or peripheral blood blasts ≥ 20%)
- Adequate cardiac function as defined by an echocardiogram or multiple gated acquisition (MUGA) scan demonstrating an ejection fraction within normal limits
Key exclusion criteria (14 listed)
- Females who are pregnant (positive β-hCG test) or lactating
- History of chronic myelogenous leukemia (CML) [t(9;22)]
- Acute promyelocytic leukemia (M3 subtype in French-American-British [FAB] classification).
- Known central nervous system (CNS) leukemia
- AML associated with congenital syndromes such as Down syndrome, Fanconi anemia, Bloom syndrome, Kostmann syndrome, or Diamond Blackfan anemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| decitabine Induction ChemotherapyAlso: E7373Arm A - 12 days (5 days of intravenous (IV) decitabine 20 mg/m^2 followed by 7 days of induction chemotherapy with IV daunorubicin 45 mg/m^2 and cytarabine 100 mg/m^2/day) | Drug | 1 |
| Induction ChemotherapyAlso: E7373Arm B - 7 days (7 days of induction chemotherapy with IV daunorubicin 45 mg/m^2 and cytarabine 100 mg/m^2/day only) | Drug | 2 |
Primary outcome
Primary Endpoint (Core Component): Complete Remission (CR) Rate as defined by International Working Group - 2003 criteria
Time frame: ~ 2 years
2 secondary outcomes
Secondary Endpoint (Core Component): Methylation of DNA following decitabine therapy.
Time frame: Until Week 3 after chemotherapy
Secondary Endpoint (Core Component): Time to platelet recovery (≥ 100,000/mm3) and time to neutrophil recovery (absolute neutrophil count [ANC] ≥ 1000/mm3) following induction chemotherapy
Time frame: Until ~ 4 weeks after last dose of induction chemotherapy
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Tarassoff, MD study director
Eisai Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing decitabine Induction Chemotherapy and Induction Chemotherapy in people with Acute Myelogenous Leukemia (AML), run by Eisai Inc. at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Endpoint (Core Component): Complete Remission (CR) Rate as defined by International Working Group - 2003 criteria (time frame: ~ 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2015.