Treateament of Newly Diagnosed Acute Monocytic Leukemia in Children
NCT ID: NCT05313958
Last Updated: 2023-07-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
43 participants
INTERVENTIONAL
2021-12-01
2026-03-30
Brief Summary
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Detailed Description
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1.To study the 3 year-overall survival of newly diagnosed monocytic leukemia treated with Cladribine and cytarabine in children.
SECONDARY OBJECTIVES
1. To describe the complete response rate following CLAG (cladribine, cytarabine and granulocyte stimulating factor) in newly diagnosed monocytic leukemia in children for intensive induction therapy.
2. To evaluate the 3-year progression-free survival in response to CLAG in children.
3. To assess the toxicity of CLAG including cumulative infection incidence, cumulative adverse effects and chemotherapy-related mortality (TRD).
4. To study the progression-free survival and overall survival (1 year, 2 year and 3 year) of newly diagnosed monocytic leukemia with positive FLT3 treated with CLAG in children and the side effects of sorafenib.
OUTLINE:
1. The induction phase includes two parts including induction therapy I(CLAG) and induction therpay II(CLAG+I/M).
2. The diagnosis and classified criteria is according to the 2016 WHO classification criteria for hematopoietic and lymphoid tissue tumors, and the consolidation therapy consists the therapeutic phases as the NOPHO-AML 2004 protocol prescribed.
INDUCTION THERAPY I: Patients receive cladribine intravenously (IV) at a dose of 5mg/m2/day combined with cytarabine 2g/m2/day on day 1-5 and granulocyte stimulating factor 5ug/kg/day on day 0-6. When blood count recover(WBC\>2.0×109/L， ANC1.0×109/L、PLT≥50×109/L) , Patients achieving a morphological leukemia free state (\< 5% blasts) or MRD\< 1% receive a second course treatment as above.
INDUCTION THERPAY II: Patients receive cladribine intravenously (IV) at a dose of 5mg/m2/day combined with cytarabine 2g/m2/day on day 1-5, mitoxantrone/idarubicin 10mg/m2/day on day 1-3 and granulocyte stimulating factor 5ug/kg/day on day 0-6. Patients achieving blast count≥5% or MRD ≥1% proceed to induction II therpy.
3. For FLT3 positive acute monocytic leukemia children, sorafenib 200mg/m2/day was taken orally until molecular biology remission for 2 years.
4. After two courses of indution phase, patients with incomplete response（MRD≥0.1%）are recommended into hematopoietic stem cell transplantation.
5. After two courses of indution phase, patients with persisting positive adverse prognosis cytogenetic abnormalities are recommended into hematopoietic stem cell transplantation.
Patients must meet one of the following risk criteria:
Standard-risk (SR) group meeting all of the following criteria:
Initial WBC \< 10,000/μL
M1 (\<5%) blasts or MRD\<1% in bone marrow after the first course of induction therapy
M1 (\<5%) blasts or MRD\<0.1% in bone marrow after two courses of induction therapy
Cytogenetic abnormalities with good prognosis
Intermediate-risk (IR) group meeting the following criteria:
Lack of low-risk and high-risk conditions
High-risk (HR) group meeting ≥ 1 of the following criteria:
M2/M3(≥5%) blasts or MRD\>5% in bone marrow after the first course of induction therapy
MRD≥0.1% in bone marrow after two course of induction therapy
Cytogenetic abnormalities with poor prognosis
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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treatment arm
The patients in this arm will receive SCCLG-M5 2022 regimen for newly dignosed acute monocytic leukemia (M5) ,including two courses of CLAG(cladribine, darubicin and cytarabine) in the induction period and followed by three courses(HA1M, HA2E, HA3) in consolidation therapy prescribed as the NOPHO-AML 2004 protocol.
The targeted drugs sorafenib 200mg/m2/day orally is used for FLT3 positive acute monocytic leukemia until molecular biology remission for 2 years.
Cladribine
5mg/㎡/day d1-5 in 2 hours, before the use of Cytarabine
G-CSF
5ug/kg/day d0-5,if Peripheral blood leukocytes\<20,000/ul
Cytarabine
2g/㎡/day d1-5 in 4 hours, after the use of Cladribine
Idarubicin
Idarubicin 10mg/m2/day or mitoxantrone 10mg/m2/day on day 1-3 in the induction therapy II
Mitoxantrone
Idarubicin 10mg/m2/day or mitoxantrone 10mg/m2/day on day 1-3 in the induction therapy II
Sorafenib
200mg/m2/day was taken orally until molecular biology remission for 2 years
Interventions
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Cladribine
5mg/㎡/day d1-5 in 2 hours, before the use of Cytarabine
G-CSF
5ug/kg/day d0-5,if Peripheral blood leukocytes\<20,000/ul
Cytarabine
2g/㎡/day d1-5 in 4 hours, after the use of Cladribine
Idarubicin
Idarubicin 10mg/m2/day or mitoxantrone 10mg/m2/day on day 1-3 in the induction therapy II
Mitoxantrone
Idarubicin 10mg/m2/day or mitoxantrone 10mg/m2/day on day 1-3 in the induction therapy II
Sorafenib
200mg/m2/day was taken orally until molecular biology remission for 2 years
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Cytologically proven acute monocytic leukemia (M5) with other treatment
Exclusion Criteria
Second tumor
Dowm's syndrome
Evolution of chronic myelogenous leukemia to blast crisis
Death or quit treatment in seven days at the begining of induction therapy
Treatment with other effective chemotherapy drugs for AML, excluding the low dose chemotherapy for the purpose of reducing leukocytes in hyperleukocytic leukemia
Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled heart, brain, liver and kidney failure etc.)
Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
1 Month
14 Years
ALL
No
Sponsors
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Third Affiliated Hospital, Sun Yat-Sen University
OTHER
Maternal and Child Health Hospital of Foshan
OTHER
The First Affiliated Hospital of Guangzhou Medical University
OTHER
Second Xiangya Hospital of Central South University
OTHER
Jiangxi Province Children's Hospital
OTHER
Southern Medical University, China
OTHER
The First Affiliated Hospital of Nanchang University
OTHER
Guangzhou First People's Hospital
OTHER
First Affiliated Hospital of Shantou University Medical College
OTHER
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
OTHER
Responsible Party
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Principal Investigators
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dunha zhou, M.D
Role: STUDY_CHAIR
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Locations
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Maternal and Child Health Hospital of Foshan
Foshan, Guangdong, China
Guangzhou First People's Hospital
Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Third Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China
Guangzhou First People's Hospital First Affiliated Hospital of Shantou University Medical College
Shantou, Guangdong, China
Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Jiangxi Province Children's Hospital Southern Medical University, China
Nanchang, Jiangxi, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Countries
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Central Contacts
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Facility Contacts
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References
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Liu LP, Zhang AL, Ruan M, Chang LX, Liu F, Chen X, Qi BQ, Zhang L, Zou Y, Chen YM, Chen XJ, Yang WY, Guo Y, Zhu XF. Prognostic stratification of molecularly and clinically distinct subgroup in children with acute monocytic leukemia. Cancer Med. 2020 Jun;9(11):3647-3655. doi: 10.1002/cam4.3023. Epub 2020 Mar 26.
Weis TM, Marini BL, Bixby DL, Perissinotti AJ. Clinical considerations for the use of FLT3 inhibitors in acute myeloid leukemia. Crit Rev Oncol Hematol. 2019 Sep;141:125-138. doi: 10.1016/j.critrevonc.2019.06.011. Epub 2019 Jun 28.
Rubnitz JE, Crews KR, Pounds S, Yang S, Campana D, Gandhi VV, Raimondi SC, Downing JR, Razzouk BI, Pui CH, Ribeiro RC. Combination of cladribine and cytarabine is effective for childhood acute myeloid leukemia: results of the St Jude AML97 trial. Leukemia. 2009 Aug;23(8):1410-6. doi: 10.1038/leu.2009.30. Epub 2009 Feb 26.
Other Identifiers
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2021A1515011809
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2021-KY-052
Identifier Type: -
Identifier Source: org_study_id
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