Treateament of Newly Diagnosed Acute Monocytic Leukemia in Children

NCT05313958 | Recruiting Phase 2 DMC

• 2 other identifiers: 2021-KY-0522021A1515011809
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 9

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.

Conditions

Leukemia, Monocytic, Acute; Pediatric AML

Keywords

Acute monocytic leukemia; pediatric; Cladribine; sorafenib

Outcome Measures

Primary Outcomes (1)

• 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.

  3 years

Secondary Outcomes (3)

• Induced remission rate (CR)

  3 years

• Safety,including cumulative infection incidence, adverse reaction and chemotherapy-related mortality (TRD)

  3 years

• Event-free survival (EFS)

  3 years

Study Arms (1)

treatment arm

EXPERIMENTAL

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.

Drug: Cladribine; Drug: G-CSF; Drug: Cytarabine; Drug: Idarubicin; Drug: Mitoxantrone; Drug: Sorafenib

Interventions

Cladribine DRUG

5mg/㎡/day d1-5 in 2 hours, before the use of Cytarabine

Also known as: cladribine injection

treatment arm

G-CSF DRUG

5ug/kg/day d0-5,if Peripheral blood leukocytes\<20,000/ul

Also known as: granulocyte

treatment arm

Cytarabine DRUG

2g/㎡/day d1-5 in 4 hours, after the use of Cladribine

Also known as: Ara-C

treatment arm

Idarubicin DRUG

Idarubicin 10mg/m2/day or mitoxantrone 10mg/m2/day on day 1-3 in the induction therapy II

Also known as: Idamycin, IDA

treatment arm

Mitoxantrone DRUG

Idarubicin 10mg/m2/day or mitoxantrone 10mg/m2/day on day 1-3 in the induction therapy II

Also known as: MIT

treatment arm

Sorafenib DRUG

200mg/m2/day was taken orally until molecular biology remission for 2 years

Also known as: sorafinib, Nexavar, sorafenib tosylate

treatment arm

Eligibility Criteria

• Age: 1 Month - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• years old
• Cytologically proven acute monocytic leukemia (M5) with other treatment

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead
• Third Affiliated Hospital, Sun Yat-Sen University: collaborator
• Maternal and Child Health Hospital of Foshan: collaborator
• The First Affiliated Hospital of Guangzhou Medical University: collaborator
• Second Xiangya Hospital of Central South University: collaborator
• Jiangxi Province Children's Hospital: collaborator
• Southern Medical University, China: collaborator
• The First Affiliated Hospital of Nanchang University: collaborator
• Guangzhou First People's Hospital: collaborator
• First Affiliated Hospital of Shantou University Medical College: collaborator

Study Sites (9)

Maternal and Child Health Hospital of Foshan

Foshan, Guangdong, China

RECRUITING

Guangzhou First People's Hospital

Guangzhou, Guangdong, China

RECRUITING

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

RECRUITING

Third Affiliated Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, China

RECRUITING

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, China

RECRUITING

Guangzhou First People's Hospital First Affiliated Hospital of Shantou University Medical College

Shantou, Guangdong, China

RECRUITING

Second Xiangya Hospital of Central South University

Changsha, Hunan, China

RECRUITING

Jiangxi Province Children's Hospital Southern Medical University, China

Nanchang, Jiangxi, China

RECRUITING

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

RECRUITING

Related Publications (3)

• 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.

  PMID: 32216042 BACKGROUND

• 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.

  PMID: 31279288 RESULT

• 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.

  PMID: 19242495 RESULT

MeSH Terms

Conditions

Leukemia, Monocytic, Acute

Interventions

Cladribine; Granulocyte Colony-Stimulating Factor; Cytarabine; Idarubicin; Mitoxantrone; Sorafenib

Condition Hierarchy (Ancestors)

Leukemia, Myeloid, Acute; Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

2-Chloroadenosine; Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Deoxyadenosines; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Arabinonucleosides; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Anthraquinones; Anthrones; Anthracenes; Quinones; Phenylurea Compounds; Urea; Amides; Benzene Derivatives; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Pyridines

Study Officials

• dunha zhou, M.D

  Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  STUDY CHAIR

Central Study Contacts

dunhua zhou, M.D

CONTACT

13560099258; zdunhua@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2021
• First Posted: April 6, 2022
• Study Start: December 1, 2021
• Primary Completion: March 30, 2026
• Study Completion: March 30, 2026
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (9)