Ignite Creation Date:
2024-05-06 @ 5:27 PM
Last Modification Date:
2024-10-26 @ 2:29 PM
Study NCT ID:
NCT05313958
Status:
RECRUITING
Last Update Posted:
2023-07-27
First Post:
2021-12-26
Brief Title:
Treateament of Newly Diagnosed Acute Monocytic Leukemia in Children
Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Organization:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study Overview
Official Title:
Treateament of Newly Diagnosed Acute Monocytic Leukemia in Children A Prospective Multicenter Study in South China
Status:
RECRUITING
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SCCLG-M5
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 CLAGcladribine 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
1To 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 ICLAG and induction therpay IICLAGIM
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 5mgm2day combined with cytarabine 2gm2day on day 1-5 and granulocyte stimulating factor 5ugkgday on day 0-6 When blood count recoverWBC20109L ANC10109LPLT50109L 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 5mgm2day combined with cytarabine 2gm2day on day 1-5 mitoxantroneidarubicin 10mgm2day on day 1-3 and granulocyte stimulating factor 5ugkgday on day 0-6 Patients achieving blast count5 or MRD 1 proceed to induction II therpy
3 For FLT3 positive acute monocytic leukemia children sorafenib 200mgm2day was taken orally until molecular biology remission for 2 years
4 After two courses of indution phase patients with incomplete responseMRD01are 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 10000μL
M1 5 blasts or MRD1 in bone marrow after the first course of induction therapy
M1 5 blasts or MRD01 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
M2M35 blasts or MRD5 in bone marrow after the first course of induction therapy
MRD01 in bone marrow after two course of induction therapy
Cytogenetic abnormalities with poor prognosis
1To 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 ICLAG and induction therpay IICLAGIM
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 5mgm2day combined with cytarabine 2gm2day on day 1-5 and granulocyte stimulating factor 5ugkgday on day 0-6 When blood count recoverWBC20109L ANC10109LPLT50109L 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 5mgm2day combined with cytarabine 2gm2day on day 1-5 mitoxantroneidarubicin 10mgm2day on day 1-3 and granulocyte stimulating factor 5ugkgday on day 0-6 Patients achieving blast count5 or MRD 1 proceed to induction II therpy
3 For FLT3 positive acute monocytic leukemia children sorafenib 200mgm2day was taken orally until molecular biology remission for 2 years
4 After two courses of indution phase patients with incomplete responseMRD01are 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 10000μL
M1 5 blasts or MRD1 in bone marrow after the first course of induction therapy
M1 5 blasts or MRD01 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
M2M35 blasts or MRD5 in bone marrow after the first course of induction therapy
MRD01 in bone marrow after two course of induction therapy
Cytogenetic abnormalities with poor prognosis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2021A1515011809 | OTHER_GRANT | Province natural science fund of Guangdong | None |