Çocuk ve Ergenlerde AML'de Moleküler Alt Tiplendirme ve MRD Temelli İndüksiyon Tedavi Seçeneklerinin Klinik Çalışması

Sade dilde özet

Bu çalışma, akut miyeloid lösemi (acute myeloid leukemia, AML) olan çocuk ve ergenlerde, hastalığın moleküler alt tipine ve minimal kalıntı hastalık (MRD) düzeyine göre belirlenen indüksiyon tedavi seçeneklerini değerlendirmektedir. Tedavide sitarabin, etoposid, venetoklaks ve gilteritinib gibi çeşitli ilaçlar kullanılmakta; çalışmaya yeni tanı almış, tedavi edilmemiş, 18 yaş altı hastalar alınmaktadır. Çalışma Faz 2 aşamasında yürütülmekte ve halen katılımcı almaktadır.

Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.

Deney bilgileri

Faz

Faz 2 (Phase 2)

Durum

Katılımcı alıyor

Sponsor

Children's Hospital of Soochow University

Müdahale

Homoharringtonine, Cytarabine, Etoposide, Venetoclax, Mitoxantrone hydrochloride liposome, Recombinant Human Granulocyte Colony-Stimulating Factor, Idarubicin Hydrochloride, Sorafenib, Gilteritinib, Avapritinib

Başlangıç

01.01.2024

Tahmini bitiş

01.12.2029

Ülkeler

China

İlgili genler

Merkezler

• Hefei, China
• Hefei, China
• Guangzhou, China
• Nanning, China
• Kaifeng, China
• Zhengzhou, China
• Changsha, China
• Changsha, China
• Suzhou, China
• Xuzhou, China
• Jinan, China
• Shanghai, China
• Beijing, China

Uygunluk kriterleri

Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.

Inclusion Criteria:

* 1、Newly diagnosed, untreated AML；
* 2、Under 18 years old;
* 3、Patients who have used hydroxyurea or cytarabine before diagnosis, but the dosage of cytarabine does not exceed 5 days, and the total dose does not exceed 500 mg/m2 (50 mg/m2, q12h × 5d)；
* 4、 Liver function：Tbil≤2×ULN, ALT/AST≤3×ULN, creatinine clearance ≥50ml/min；Cardiac NYHA grading\<3；SaO2\>92%;
* 5、No active infection (symptoms resolved for more than 3 days if infected)
* 6、ECOG\<2;
* 7、Expected survival time greater than 12 weeks;
* 9、Obtain the consent of the child and/or guardian and sign the informed consent form.

Exclusion Criteria:

* 1、Acute megakaryocytic leukemia (AMKL)；
* 2、Acute promyelocytic leukemia (APL);
* 3、Treatment-related secondary AML and AML with definite MDS transformation；
* 4、Myeloproliferative neoplasm (such as Juvenile myelomonocytic leukemia, JMML);
* 5、AML secondary to congenital bone marrow failure (such as AML secondary to Fanconi anemia (FA)；
* 6、AML secondary to Down syndrome;
* 7、Only temporary chemotherapy, radiotherapy, or immunotherapy, but not systematic treatment according to the treatment plan;
* 8、 Temporary chemotherapy, radiotherapy, or immunotherapy only, not systemic therapy per protocol;
* 9、Having any significant abnormal concurrent disease or mental illness that impacts the life safety and compliance of the patient and impacts informed consent, study participation, follow-up, or interpretation of results. In this case, all the participating units are required to report directly to the responsible person for this project to jointly decide whether they meet the exclusion criteria；
* 10、Patients with very poor nutritional status, severe infection, cardiac insufficiency, and intolerance to chemotherapy;
* 11、Relapsed AML at any time；
* 12、The attending physician considers that the patient is not suitable for entering the study protocol based on the patient's physical condition, economic status, and other factors.