Acute Myeloid LeukemiaNCT03173612
The Efficiency of CAMS (Chinese Academy of Medical Sciences)-2016 Trial for Pediatric Acute Myeloid Leukemia
A study testing Dasatinib in people with Acute Myeloid Leukemia, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial summary
The purpose of this study is to evaluate that whether the AML (acute myeloid leukemia)-CAMS (Chinese Academy of Medical Sciences)-2016 regimen, includes risk-stratified therapy and the use of Dasatinib in CBF (Core binding factor)-AML, can improve the outcome in childhood AML. Read more about this study
- Who is it for?
- Ages 6 months to 16 years
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Dasatinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteChina
- Study dates
- Aug 2016to Dec 2024
- Phase
- Interventional
- 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 6 months to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Newly diagnosis of de novo Acute Myeloid Leukemia
Who cannot join
- Children with Down's syndrome and acute promyelocytic leukemia, hybrid acute leukemia
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
InstituteHBDH
Tianjin, Tianjin Municipality, 300020
Zhu Xiaofan, 86-21-23909001, xfzhu@ihcams.ac.cn
Guo Ye
About this study
Official title: The Efficiency of CAMS-2016 Trial for the Newly Diagnosed Pediatric Acute Myeloid Leukemia: A Prospective Single Centre Trial From China
The purpose of this study is to evaluate that whether the AML (acute myeloid leukemia)-CAMS (Chinese Academy of Medical Sciences)-2016 regimen, includes risk-stratified therapy and the use of Dasatinib in CBF (Core binding factor)-AML, can improve the outcome in childhood AML.
Read the detailed description
Primary AML includes CBF(Core binding factor)-AML and non-CBF-AML. After the second course of therapy, CBF-AML are stratified into two risk groups: low-risk children are defined as those with CR after MAE or CAG, high-risk children are those with CR after consolidation course 1 or IAE. Non-CBF-AML patients in remission are stratified into three risk groups: low-risk children are defined as those with t(1；11)(q21；q23) , GATA1, NPM1/IDH1/IDH2 without FLT3/ITD,or an age younger than 2 years without high-risk factors; high-risk children are those with CR after consolidation course 1 or IAE or with abnormalities of monosomy 7, 5q- , t(16;21), t(9;22) (Philadelphia chromosome [Ph1]), FLT3/ITD,-17/TP53, RPN1-MECOM, RUNX1-EVI1, MLF1-NPM1, PRDM16-RPN1, DEK-NUP214, ETV6(TEL)-HLXB9(MNX1), NUP98-NSD1; intermediate-risk children are those who were not in either a low-risk or high-risk group.Low-risk children were treated only with chemotherapy, regardless the availability of a suitable HSCT donor. All high-risk children were allocated to Allo-hematopoietic stem cell transplantation (HSCT) in the first remission, including unrelated bone marrow transplantation (BMT). Auto-HSCT is recommended for intermediate-risk children. No prophylactic cranial irradiation is included in the protocol. Patients are treated on an inpatient basis during each treatment phase.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Dasatinib
- 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.
DasatinibDrug
Also called cytarabine(Ara-C), etoposide(VP-16), idarubicin(IDA), aclacinomycin(Acla)
Primary AML includes CBF-AML and non-CBF-AML. Children with a WBC (white blood cell) lower than 4,000/μL and low proliferative bone marrow at diagnosis are treated with CAG. Other children are treated with MAE. The rescue regimen for children who showed M3 marrow after MAE or CAG is IAE. Consolidation therapy consisted of four (for CBF-AML) or five (for non-CBF-AML) courses, and triplein trathecal therapy is given as a part of each course. After the second course of therapy, CBF-AML are stratified into two risk groups, while non-CBF-AML patients in remission are stratified into three risk groups.Consolidation regimen for CBF-AML includes IA, MA, IA, MA. Dasatinib is used in CBF-AML as a part of consolidation therapy. Consolidation regimen for non-CBF-AML includes IAE, MAE, EA, IAE, EA or MAE.
| Study group | Role | What they receive |
|---|---|---|
| AML-CAMS-2016 trial | Experimental | AML-CAMS-2016 regimen includes risk-stratified therapy and the use of Dasatinib in CBF-AML.The induction regimen includes MAE (etoposide 150mg/㎡/d d1-5, cytarabine 200mg/㎡/d d6-12 , mitoxantrone 5 mg/㎡/d d6-10), CAG (aclacinomycin 6mg/㎡/d d1-8, Ara-C 10mg/㎡ q12h d1-14 , G-CSF 200ug/㎡/d d1-14),IAE (idarubicin 8 mg/㎡/d d1-3, Ara-C 500mg/㎡/d d1-3 d8-10, VP-16 200mg/㎡/d d8-10).Consolidation regimen includes IA (Ara-C 1g/㎡ q12h d1-4, IDA 10mg/㎡/d d1), MA (Ara-C 1g/㎡ q12h d1-4, MTZ 5mg/㎡/d d1-3), IAE (IDA 10mg/㎡/d d1, Ara-C 3g/㎡ q12h d1-3, VP-16 100mg/㎡/d d1-5), MAE (Ara-C 200mg/㎡ d4-8, VP-16 150mg/㎡/d d1-3, MTZ 5mg/㎡/d d4-6),EA (Ara-C 2g/㎡ q12h d1-5, VP-16 100mg/㎡/d d1-5),IAE (IDA 10mg/㎡/d d1, Ara-C 3g/㎡ q12h d1-3, VP-16 100mg/㎡/d d1-5),EA (Ara-C 2g/㎡ q12h d1-5, VP-16 100mg/㎡/d d1-5),MAE (Ara-C 200mg/㎡ d4-8, VP-16 150mg/㎡/d d1-3, MTZ 5mg/㎡/d d4-6). Dasatinib (60-80mg/㎡) is used in CBF-AML as a part of consolidation therapy. Receives: Drug: Dasatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete remission
Fewer than 5% blast cells in the bone marrow aspirate and the absence of extramedullary involvement (EMI)
Measured: through study completion, an average of 7 year
Overall Survival (OS)
Overall Survival
Measured: From date of diagnosed until the date of death from any cause, assessed up to 60 months
Event-free Survival (EFS)
Event-free Survival
Measured: From date of diagnosed until the date of first relapse or date of death from any cause, whichever came first, assessed up to 60 months
Disease-free Survival (DFS)
Disease-free Survival
Measured: From date of remission until the date of first relapse or date of death from any cause, whichever came first, assessed up to 60 months
Secondary outcomes (1)
all cause mortality
Dead during the treatment
Measured: one year after diagnosed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2017
- Study startAug 2016
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhu Xiaofan, Institute of Hematology & Blood Diseases Hospital, China
- Investigators
- Zhu Xiaofan, Study chair, Institute of Hematology & Blood Diseases Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03173612
- Sponsor's protocol ID
- AML-CAMS-2016
- Status last verified
- Aug 2022
- First submitted
- 16 May 2017
- Last updated
- 3 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficiency of CAMS-2016 Trial for the Newly Diagnosed Pediatric Acute Myeloid Leukemia: A Prospective Single Centre Trial From China
- ClinicalTrials.gov ID
- NCT03173612
- Acronym / sponsor ID
- AML-CAMS-2016
- Conditions
- Acute Myeloid Leukemia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 2 Jun 2017 (actual)
- 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 that whether the AML (acute myeloid leukemia)-CAMS (Chinese Academy of Medical Sciences)-2016 regimen, includes risk-stratified therapy and the use of Dasatinib in CBF (Core binding factor)-AML, can improve the outcome in childhood AML.
Detailed description
Primary AML includes CBF(Core binding factor)-AML and non-CBF-AML. After the second course of therapy, CBF-AML are stratified into two risk groups: low-risk children are defined as those with CR after MAE or CAG, high-risk children are those with CR after consolidation course 1 or IAE. Non-CBF-AML patients in remission are stratified into three risk groups: low-risk children are defined as those with t(1；11)(q21；q23) , GATA1, NPM1/IDH1/IDH2 without FLT3/ITD,or an age younger than 2 years without high-risk factors; high-risk children are those with CR after consolidation course 1 or IAE or with abnormalities of monosomy 7, 5q- , t(16;21), t(9;22) (Philadelphia chromosome [Ph1]), FLT3/ITD,-17/TP53, RPN1-MECOM, RUNX1-EVI1, MLF1-NPM1, PRDM16-RPN1, DEK-NUP214, ETV6(TEL)-HLXB9(MNX1), NUP98-NSD1; intermediate-risk children are those who were not in either a low-risk or high-risk group.Low-risk children were treated only with chemotherapy, regardless the availability of a suitable HSCT donor. All high-risk children were allocated to Allo-hematopoietic stem cell transplantation (HSCT) in the first remission, including unrelated bone marrow transplantation (BMT). Auto-HSCT is recommended for intermediate-risk children. No prophylactic cranial irradiation is included in the protocol. Patients are treated on an inpatient basis during each treatment phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AML-CAMS-2016 trial | Experimental | Drug: DasatinibAML-CAMS-2016 regimen includes risk-stratified therapy and the use of Dasatinib in CBF-AML.The induction regimen includes MAE (etoposide 150mg/㎡/d d1-5, cytarabine 200mg/㎡/d d6-12 , mitoxantrone 5 mg/㎡/d d6-10), CAG (aclacinomycin 6mg/㎡/d d1-8, Ara-C 10mg/㎡ q12h d1-14 , G-CSF 200ug/㎡/d d1-14),IAE (idarubicin 8 mg/㎡/d d1-3, Ara-C 500mg/㎡/d d1-3 d8-10, VP-16 200mg/㎡/d d8-10).Consolidation regimen includes IA (Ara-C 1g/㎡ q12h d1-4, IDA 10mg/㎡/d d1), MA (Ara-C 1g/㎡ q12h d1-4, MTZ 5mg/㎡/d d1-3), IAE (IDA 10mg/㎡/d d1, Ara-C 3g/㎡ q12h d1-3, VP-16 100mg/㎡/d d1-5), MAE (Ara-C 200mg/㎡ d4-8, VP-16 150mg/㎡/d d1-3, MTZ 5mg/㎡/d d4-6),EA (Ara-C 2g/㎡ q12h d1-5, VP-16 100mg/㎡/d d1-5),IAE (IDA 10mg/㎡/d d1, Ara-C 3g/㎡ q12h d1-3, VP-16 100mg/㎡/d d1-5),EA (Ara-C 2g/㎡ q12h d1-5, VP-16 100mg/㎡/d d1-5),MAE (Ara-C 200mg/㎡ d4-8, VP-16 150mg/㎡/d d1-3, MTZ 5mg/㎡/d d4-6). Dasatinib (60-80mg/㎡) is used in CBF-AML as a part of consolidation therapy. |
Who may qualify
- Ages
- 6 months to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Newly diagnosis of de novo Acute Myeloid Leukemia
Key exclusion criteria (1 listed)
- Children with Down's syndrome and acute promyelocytic leukemia, hybrid acute leukemia
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 |
|---|---|---|
| DasatinibAlso: cytarabine(Ara-C), etoposide(VP-16), idarubicin(IDA), aclacinomycin(Acla)Primary AML includes CBF-AML and non-CBF-AML. Children with a WBC (white blood cell) lower than 4,000/μL and low proliferative bone marrow at diagnosis are treated with CAG. Other children are treated with MAE. The rescue regimen for children who showed M3 marrow after MAE or CAG is IAE. Consolidation therapy consisted of four (for CBF-AML) or five (for non-CBF-AML) courses, and triplein trathecal therapy is given as a part of each course. After the second course of therapy, CBF-AML are stratified into two risk groups, while non-CBF-AML patients in remission are stratified into three risk groups.Consolidation regimen for CBF-AML includes IA, MA, IA, MA. Dasatinib is used in CBF-AML as a part of consolidation therapy. Consolidation regimen for non-CBF-AML includes IAE, MAE, EA, IAE, EA or MAE. | Drug | AML-CAMS-2016 trial |
Primary outcome
Complete remission
Time frame: through study completion, an average of 7 year
Fewer than 5% blast cells in the bone marrow aspirate and the absence of extramedullary involvement (EMI)
Overall Survival (OS)
Time frame: From date of diagnosed until the date of death from any cause, assessed up to 60 months
Overall Survival
Event-free Survival (EFS)
Time frame: From date of diagnosed until the date of first relapse or date of death from any cause, whichever came first, assessed up to 60 months
Event-free Survival
Disease-free Survival (DFS)
Time frame: From date of remission until the date of first relapse or date of death from any cause, whichever came first, assessed up to 60 months
Disease-free Survival
1 secondary outcome
all cause mortality
Time frame: one year after diagnosed
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2022.
- Individual participant dataSharing planned: Undecided
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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.
Zhu Xiaofan study chair
Institute of Hematology & Blood Diseases Hospital, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dasatinib in people with Acute Myeloid Leukemia, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
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 1 inclusion and 1 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 3 Aug 2022. 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 China. 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.
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 Zhu Xiaofan (86-21-23909001, xfzhu@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete remission (time frame: through study completion, an average of 7 year). The study lists 4 primary outcomes in all. 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 3 Aug 2022.