Pediatric Acute Myeloid LeukemiaPhase 2NCT02848183
Optimal Treatment Strategy Based on for Pediatric AML
A Phase 2 study testing Cytarabine, Idarubicin and Mitoxantrone in people with Pediatric Acute Myeloid Leukemia, run by Samsung Medical Center at 3 sites in South Korea.
Trial summary
The purpose of this study is to optimize therapy according to the known risk factors and treatment response in pediatric acute myeloid leukemia (AML) Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Pediatric Acute Myeloid Leukemia
- What is being tested?
- Cytarabine, Idarubicin and Mitoxantrone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 3 sitesSouth Korea
- Study dates
- Jan 2016to Dec 2020
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients who were newly diagnosed with de novo AML
- Patients who had recurrent cytogenetic abnormalities of AML even though the bone marrow blast percent is lower than 20%
Who cannot join
- Acute promyelocytic leukemia
- Down syndrome AML
- Therapy-related AML
- AML developed from myelodysplastic syndrome or other marrow failure syndrome
- Isolated myeloid sarcoma without bone marrow involvement
- Patients who cannot undergo chemotherapy as scheduled due to serious complications at diagnosis
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites, 3 recruiting
- Recruiting
Chonnam National University Hwasun Hospital
Chonnam
Hoon Kook, MD, PhD, hoonkook@chonnam.ac.kr
- Recruiting
Samsung Medical Center
Seoul
Keon Hee, MD, PhD, 82-2-3410-3532, hema2170@skku.edu
- Recruiting
St. Mary Hospital
Seoul
Bin Cho, MD, PhD, chobinkr@catholic.ac.kr
About this study
Official title: Optimal Treatment Strategy Based on Prognostic Groups for Pediatric de Novo Acute Myeloid Leukemia
The purpose of this study is to optimize therapy according to the known risk factors and treatment response in pediatric acute myeloid leukemia (AML)
Read the detailed description
- Risk group assessment Favorable prognosis group: Low risk features + Good response
Intermediate prognosis group:
- Low risk features + Delayed response-1
- Standard risk features + Good response
- Standard risk features + Delayed response-1
Poor prognosis group:
- Any high risk features irrespective of treatment response
- Any delayed response-2 irrespective of risk features
- Any refractory state irrespective of risk features
- Any early relapse
II. Chemotherapy Induction-1: Cytarabine + idarubicin Induction-2: High dose (HD) cytarabine + mitoxantrone Consolidation-1: Cytarabine + idarubicin Consolidation-2: HD cytarabine + etoposide Consolidation-3: HD cytarabine + mitoxantrone Consolidation-4: HD cytarabine + etoposide
III. Allogeneic hematopoietic stem cell transplantation (HSCT) Favorable prognosis group: chemotherapy only Intermediate prognosis group: chemotherapy or HSCT with reduced intensity conditioning Poor prognosis group: HSCT with myeloablative conditioning
- Conditions
- Pediatric Acute Myeloid Leukemia
- Being tested
- Cytarabine, Idarubicin, Mitoxantrone, Etoposide, Hematopoietic stem cell transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CytarabineDrug
IdarubicinDrug
MitoxantroneDrug
EtoposideDrug
Hematopoietic stem cell transplantationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Pediatric de novo acute myeloid leukemia | Experimental | I. Chemotherapy Induction-1: Cytarabine + idarubicin Induction-2: High dose (HD) cytarabine + mitoxantrone Consolidation-1: Cytarabine + idarubicin Consolidation-2: HD cytarabine + etoposide Consolidation-3: HD cytarabine + mitoxantrone Consolidation-4: HD cytarabine + etoposide
II. Allogeneic hematopoietic stem cell transplantation (HSCT) Favorable prognosis group: chemotherapy only Intermediate prognosis group: chemotherapy or HSCT with reduced intensity conditioning Poor prognosis group: HSCT with myeloablative conditioning Receives: Drug: Cytarabine; Drug: Idarubicin; Drug: Mitoxantrone; Drug: Etoposide; Procedure: Hematopoietic stem cell transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of event free survival
Measured: Up to 5 years
Secondary outcomes (1)
Proportion of patients who achieved complete remission
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2016 (estimated)
- Study startJan 2016
- Primary completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- Not applicable
- Intervention model
- Single group
- Enrolment
- 350 participants
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02848183
- Sponsor's protocol ID
- 2015-11-028
- Status last verified
- Jul 2016
- First submitted
- 26 Jul 2016
- Last updated
- 28 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Treatment Strategy Based on Prognostic Groups for Pediatric de Novo Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT02848183
- Acronym / sponsor ID
- 2015-11-028
- Conditions
- Pediatric Acute Myeloid Leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 350 participants
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Dec 2020 (estimated)
- First posted
- 28 Jul 2016 (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 optimize therapy according to the known risk factors and treatment response in pediatric acute myeloid leukemia (AML)
Detailed description
- Risk group assessment Favorable prognosis group: Low risk features + Good response
Intermediate prognosis group:
- Low risk features + Delayed response-1
- Standard risk features + Good response
- Standard risk features + Delayed response-1
Poor prognosis group:
- Any high risk features irrespective of treatment response
- Any delayed response-2 irrespective of risk features
- Any refractory state irrespective of risk features
- Any early relapse
II. Chemotherapy Induction-1: Cytarabine + idarubicin Induction-2: High dose (HD) cytarabine + mitoxantrone Consolidation-1: Cytarabine + idarubicin Consolidation-2: HD cytarabine + etoposide Consolidation-3: HD cytarabine + mitoxantrone Consolidation-4: HD cytarabine + etoposide
III. Allogeneic hematopoietic stem cell transplantation (HSCT) Favorable prognosis group: chemotherapy only Intermediate prognosis group: chemotherapy or HSCT with reduced intensity conditioning Poor prognosis group: HSCT with myeloablative conditioning
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric de novo acute myeloid leukemia | Experimental | Drug: Cytarabine, Drug: Idarubicin, Drug: Mitoxantrone, Drug: Etoposide, Procedure: Hematopoietic stem cell transplantationI. Chemotherapy Induction-1: Cytarabine + idarubicin Induction-2: High dose (HD) cytarabine + mitoxantrone Consolidation-1: Cytarabine + idarubicin Consolidation-2: HD cytarabine + etoposide Consolidation-3: HD cytarabine + mitoxantrone Consolidation-4: HD cytarabine + etoposide II. Allogeneic hematopoietic stem cell transplantation (HSCT) Favorable prognosis group: chemotherapy only Intermediate prognosis group: chemotherapy or HSCT with reduced intensity conditioning Poor prognosis group: HSCT with myeloablative conditioning |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Patients who were newly diagnosed with de novo AML
- Patients who had recurrent cytogenetic abnormalities of AML even though the bone marrow blast percent is lower than 20%
Key exclusion criteria (6 listed)
- Acute promyelocytic leukemia
- Down syndrome AML
- Therapy-related AML
- AML developed from myelodysplastic syndrome or other marrow failure syndrome
- Isolated myeloid sarcoma without bone marrow involvement
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 |
|---|---|---|
| Cytarabine | Drug | Pediatric de novo acute myeloid leukemia |
| Idarubicin | Drug | Pediatric de novo acute myeloid leukemia |
| Mitoxantrone | Drug | Pediatric de novo acute myeloid leukemia |
| Etoposide | Drug | Pediatric de novo acute myeloid leukemia |
| Hematopoietic stem cell transplantation | Procedure or surgery | Pediatric de novo acute myeloid leukemia |
Primary outcome
Rate of event free survival
Time frame: Up to 5 years
1 secondary outcome
Proportion of patients who achieved complete remission
Time frame: Up to 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2016.
- Individual participant dataSharing planned: No
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cytarabine, Idarubicin and Mitoxantrone in people with Pediatric Acute Myeloid Leukemia, run by Samsung Medical Center at 3 sites in South Korea.
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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 28 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Keon Hee Yoo, MD, PhD (82-2-3410-3532, hema2170@skku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of event free survival (time frame: Up to 5 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 28 Jul 2016.