Treatment for children with newly diagnosed acute monocytic leukemia
Treateament of Newly Diagnosed Acute Monocytic Leukemia in Children： A Prospective Multicenter Study in South China
This study is testing a new combination of medicines to see if it can help children with newly diagnosed acute monocytic leukemia live longer and feel better.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 43 (estimated) |
| Ages | 1 Month to 14 Years |
| Sex | All |
| Sponsor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 9 sites (Foshan, Guangdong and 8 other locations) |
| Trial ID | NCT05313958 on ClinicalTrials.gov |
What this trial studies
This multicenter, single-arm intervention trial aims to treat newly diagnosed acute monocytic leukemia (M5) in children using a regimen that combines cladribine and cytarabine. The study will evaluate the overall survival rate over three years and assess the complete response rate following the treatment. Additionally, it will monitor the progression-free survival and the toxicity associated with the treatment, including the effects of sorafenib for patients with FLT3 positive leukemia. The trial is conducted across ten centers in South China, following established protocols for induction and consolidation therapy.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 0-14 years with cytologically proven acute monocytic leukemia.
Not a fit: Patients with secondary tumors, severe uncontrolled medical conditions, or those who have previously received effective chemotherapy for AML may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve survival rates and quality of life for children diagnosed with acute monocytic leukemia.
How similar studies have performed: Other studies have shown promising results with similar treatment approaches, particularly in the use of cladribine and cytarabine for acute leukemias.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Foshan, Guangdong and 8 other locations
- 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)
Study contacts
- Study coordinator: dunhua zhou, M.D
- Email: zdunhua@163.com
- Phone: 13560099258
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.