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The Efficiency of CAMS (Chinese Academy of Medical Sciences)-2016 Trial for Pediatric Acute Myeloid Leukemia

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ClinicalTrials.gov Identifier: NCT03173612
Recruitment Status : Recruiting
First Posted : June 2, 2017
Last Update Posted : March 12, 2019
Sponsor:
Information provided by (Responsible Party):
Zhu Xiaofan, Institute of Hematology & Blood Diseases Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Drug: Dasatinib Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 132 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Efficiency of CAMS-2016 Trial for the Newly Diagnosed Pediatric Acute Myeloid Leukemia: A Prospective Single Centre Trial From China
Study Start Date : August 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2022


Arm Intervention/treatment
Experimental: AML-CAMS-2016 trial
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.
Drug: Dasatinib
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.
Other Names:
  • cytarabine(Ara-C)
  • etoposide(VP-16)
  • idarubicin(IDA)
  • aclacinomycin(Acla)
  • granulocyte colony-stimulating factor(G-CSF)
  • Mitoxantrone




Primary Outcome Measures :
  1. 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)

  2. Overall Survival (OS) [ Time Frame: From date of diagnosed until the date of death from any cause, assessed up to 60 months ]
    Overall Survival

  3. 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

  4. 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


Secondary Outcome Measures :
  1. all cause mortality [ Time Frame: one year after diagnosed ]
    Dead during the treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Newly diagnosis of de novo Acute Myeloid Leukemia

Exclusion Criteria:

  • Children with Down's syndrome and acute promyelocytic leukemia, hybrid acute leukemia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03173612


Contacts
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Contact: Zhu Xiaofan 86-21-23909001 xfzhu@ihcams.ac.cn

Locations
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China, Tianjin
InstituteHBDH Recruiting
Tianjin, Tianjin, China, 300020
Contact: Zhu Xiaofan    86-21-23909001    xfzhu@ihcams.ac.cn   
Principal Investigator: Guo Ye         
Principal Investigator: Yang Wenyu         
Principal Investigator: Chen Xiaojuan         
Principal Investigator: Chen Yumei         
Principal Investigator: Ruan Min         
Sponsors and Collaborators
Institute of Hematology & Blood Diseases Hospital
Investigators
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Study Chair: Zhu Xiaofan Institute of Hematology & Blood Diseases Hospital

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Responsible Party: Zhu Xiaofan, Director, Institute of Hematology & Blood Diseases Hospital
ClinicalTrials.gov Identifier: NCT03173612     History of Changes
Other Study ID Numbers: AML-CAMS-2016
First Posted: June 2, 2017    Key Record Dates
Last Update Posted: March 12, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Cytarabine
Etoposide
Mitoxantrone
Idarubicin
Dasatinib
Aclacinomycins
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protein Kinase Inhibitors
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antibiotics, Antineoplastic
Adjuvants, Immunologic