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Treateament of Newly Diagnosed Acute Monocytic Leukemia in Children (SCCLG-M5)

Primary Purpose

Leukemia, Monocytic, Acute, Pediatric AML

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Cladribine
G-CSF
Cytarabine
Idarubicin
Mitoxantrone
Sorafenib
Sponsored by
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia, Monocytic, Acute focused on measuring Acute monocytic leukemia, pediatric, Cladribine, sorafenib

Eligibility Criteria

1 Month - 14 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

0-14 years old

Cytologically proven acute monocytic leukemia (M5) with other treatment

Exclusion Criteria:

Secondary to immunodeficiency or MDS

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

Sites / Locations

  • Maternal and Child Health Hospital of FoshanRecruiting
  • Guangzhou First People's HospitalRecruiting
  • The First Affiliated Hospital of Guangzhou Medical UniversityRecruiting
  • Third Affiliated Hospital, Sun Yat-Sen UniversityRecruiting
  • Zhujiang Hospital of Southern Medical UniversityRecruiting
  • Guangzhou First People's Hospital First Affiliated Hospital of Shantou University Medical CollegeRecruiting
  • Second Xiangya Hospital of Central South UniversityRecruiting
  • Jiangxi Province Children's Hospital Southern Medical University, ChinaRecruiting
  • The First Affiliated Hospital of Nanchang UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

treatment arm

Arm Description

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.

Outcomes

Primary Outcome Measures

Overall survival (OS)
TOS was defined as time from diagnostic date through the date of death due to any reasons. For all other participants, the last follow-up available was taken as the last control. If the participant had not completed the study, the date of the last visit available was considered.

Secondary Outcome Measures

Induced remission rate (CR)
According to the time point specified in the treatment plan (22 days after the end of induction I, 29-43 days after the end of induction II and before each consolidation scheme) bone marrow puncture and lumbar puncture were performed. The follow-up contents included the detection of the count of primitive / immature lymphocytes and flow MRD. If there was a positive gene at the onset, the quantitative monitoring of the gene should be performed as MRD data at the same time. If the gene cannot be analyzed quantitatively, PCR qualitative analysis should still be performed as the monitoring basis
Safety,including cumulative infection incidence, adverse reaction and chemotherapy-related mortality (TRD)
During treatment, closely monitor relevant laboratory tests, register adverse reaction records, and report the records according to the requirements of CRF form.
Event-free survival (EFS)
EFS was estimated from date of diagnosis until date of one of the following events: relapse, refractory disease, second malignancy or death from any reason.

Full Information

First Posted
December 26, 2021
Last Updated
July 25, 2023
Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Collaborators
Third Affiliated Hospital, Sun Yat-Sen University, Maternal and Child Health Hospital of Foshan, The First Affiliated Hospital of Guangzhou Medical University, Second Xiangya Hospital of Central South University, Jiangxi Province Children's Hospital, Southern Medical University, China, The First Affiliated Hospital of Nanchang University, Guangzhou First People's Hospital, First Affiliated Hospital of Shantou University Medical College
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1. Study Identification

Unique Protocol Identification Number
NCT05313958
Brief Title
Treateament of Newly Diagnosed Acute Monocytic Leukemia in Children
Acronym
SCCLG-M5
Official Title
Treateament of Newly Diagnosed Acute Monocytic Leukemia in Children: A Prospective Multicenter Study in South China
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
March 30, 2026 (Anticipated)
Study Completion Date
March 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Collaborators
Third Affiliated Hospital, Sun Yat-Sen University, Maternal and Child Health Hospital of Foshan, The First Affiliated Hospital of Guangzhou Medical University, Second Xiangya Hospital of Central South University, Jiangxi Province Children's Hospital, Southern Medical University, China, The First Affiliated Hospital of Nanchang University, Guangzhou First People's Hospital, First Affiliated Hospital of Shantou University Medical College

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a multicenter, single arm, prospective, intervention trial. Since cladribine can enhance the biological activity and self-protection of cytarabine, giving cladribine and cytarabine together may kill more cancer cells. 10 centers from South China Childhood Leukaemia Collaborative Group carry out the SCCLG-M5-2022 regimen including two courses of CLAG(cladribine, darubicin and cytarabine) in the induction period for the treatment of newly dignosed acute monocytic leukemia (M5). The targeted drugs sorafenib is used for FLT3 positive acute monocytic leukemia to inhibit the serine / threonine kinase activity of FLT3.
Detailed Description
PRIMARY OBJECTIVES 1.To study the 3 year-overall survival of newly diagnosed monocytic leukemia treated with Cladribine and cytarabine in children. SECONDARY OBJECTIVES 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. To evaluate the 3-year progression-free survival in response to CLAG in children. To assess the toxicity of CLAG including cumulative infection incidence, cumulative adverse effects and chemotherapy-related mortality (TRD). 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: The induction phase includes two parts including induction therapy I(CLAG) and induction therpay II(CLAG+I/M). 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. For FLT3 positive acute monocytic leukemia children, sorafenib 200mg/m2/day was taken orally until molecular biology remission for 2 years. After two courses of indution phase, patients with incomplete response(MRD≥0.1%)are recommended into hematopoietic stem cell transplantation. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Monocytic, Acute, Pediatric AML
Keywords
Acute monocytic leukemia, pediatric, Cladribine, sorafenib

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
43 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
treatment arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Cladribine
Other Intervention Name(s)
cladribine injection
Intervention Description
5mg/㎡/day d1-5 in 2 hours, before the use of Cytarabine
Intervention Type
Drug
Intervention Name(s)
G-CSF
Other Intervention Name(s)
granulocyte
Intervention Description
5ug/kg/day d0-5,if Peripheral blood leukocytes<20,000/ul
Intervention Type
Drug
Intervention Name(s)
Cytarabine
Other Intervention Name(s)
Ara-C
Intervention Description
2g/㎡/day d1-5 in 4 hours, after the use of Cladribine
Intervention Type
Drug
Intervention Name(s)
Idarubicin
Other Intervention Name(s)
Idamycin, IDA
Intervention Description
Idarubicin 10mg/m2/day or mitoxantrone 10mg/m2/day on day 1-3 in the induction therapy II
Intervention Type
Drug
Intervention Name(s)
Mitoxantrone
Other Intervention Name(s)
MIT
Intervention Description
Idarubicin 10mg/m2/day or mitoxantrone 10mg/m2/day on day 1-3 in the induction therapy II
Intervention Type
Drug
Intervention Name(s)
Sorafenib
Other Intervention Name(s)
sorafinib, Nexavar, sorafenib tosylate
Intervention Description
200mg/m2/day was taken orally until molecular biology remission for 2 years
Primary Outcome Measure Information:
Title
Overall survival (OS)
Description
TOS was defined as time from diagnostic date through the date of death due to any reasons. For all other participants, the last follow-up available was taken as the last control. If the participant had not completed the study, the date of the last visit available was considered.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Induced remission rate (CR)
Description
According to the time point specified in the treatment plan (22 days after the end of induction I, 29-43 days after the end of induction II and before each consolidation scheme) bone marrow puncture and lumbar puncture were performed. The follow-up contents included the detection of the count of primitive / immature lymphocytes and flow MRD. If there was a positive gene at the onset, the quantitative monitoring of the gene should be performed as MRD data at the same time. If the gene cannot be analyzed quantitatively, PCR qualitative analysis should still be performed as the monitoring basis
Time Frame
3 years
Title
Safety,including cumulative infection incidence, adverse reaction and chemotherapy-related mortality (TRD)
Description
During treatment, closely monitor relevant laboratory tests, register adverse reaction records, and report the records according to the requirements of CRF form.
Time Frame
3 years
Title
Event-free survival (EFS)
Description
EFS was estimated from date of diagnosis until date of one of the following events: relapse, refractory disease, second malignancy or death from any reason.
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 0-14 years old Cytologically proven acute monocytic leukemia (M5) with other treatment Exclusion Criteria: Secondary to immunodeficiency or MDS 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
dunhua zhou, M.D
Phone
13560099258
Email
zdunhua@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
dunha zhou, M.D
Organizational Affiliation
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Official's Role
Study Chair
Facility Information:
Facility Name
Maternal and Child Health Hospital of Foshan
City
Foshan
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
riling chen, M.D
Phone
19820318067
Email
chenrl319@163.com
Facility Name
Guangzhou First People's Hospital
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
lina wang, M.D
Phone
18922234317
Email
wanglina_11@yeah.net
Facility Name
The First Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
yawei zhou, M.D
Phone
136423337577
Email
zywyhscg@qq.com
Facility Name
Third Affiliated Hospital, Sun Yat-Sen University
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
huiqin chen, M.D
Phone
13724819908
Email
chenhuiqinchq@126.com
Facility Name
Zhujiang Hospital of Southern Medical University
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
lihua yang, M.D
Phone
13580532469
Email
yanglihua@163.com
Facility Name
Guangzhou First People's Hospital First Affiliated Hospital of Shantou University Medical College
City
Shantou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
beiyan wu, M.D
Phone
13802336066
Email
1261305798@qq.com
Facility Name
Second Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
wuqing wan
Phone
13507316963
Email
wanwuqing65@163.com
Facility Name
Jiangxi Province Children's Hospital Southern Medical University, China
City
Nanchang
State/Province
Jiangxi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
changda liang, M.D
Phone
13879175309
Email
liangchangda@163.com
Facility Name
The First Affiliated Hospital of Nanchang University
City
Nanchang
State/Province
Jiangxi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
qiwen chen, M.D
Phone
13970807656
Email
13970807656@163.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32216042
Citation
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.
Results Reference
background
PubMed Identifier
31279288
Citation
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.
Results Reference
result
PubMed Identifier
19242495
Citation
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.
Results Reference
result

Learn more about this trial

Treateament of Newly Diagnosed Acute Monocytic Leukemia in Children

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