Status:
RECRUITING
Treateament of Newly Diagnosed Acute Monocytic Leukemia in Children
Lead Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Collaborating Sponsors:
Third Affiliated Hospital, Sun Yat-Sen University
Maternal and Child Health Hospital of Foshan
Conditions:
Leukemia, Monocytic, Acute
Pediatric AML
Eligibility:
All Genders
1-14 years
Phase:
PHASE2
PHASE3
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 ma...
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 1. To describe the complete ...
Eligibility Criteria
Inclusion
- 0-14 years old
- Cytologically proven acute monocytic leukemia (M5) with other treatment
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 30 2026
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT05313958
Start Date
December 1 2021
End Date
March 30 2026
Last Update
July 27 2023
Active Locations (9)
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1
Maternal and Child Health Hospital of Foshan
Foshan, Guangdong, China
2
Guangzhou First People's Hospital
Guangzhou, Guangdong, China
3
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
4
Third Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China