T-cell Acute Lymphoblastic Leukemia
Conditions
Interventions
ETP/near-ETP T-ALL Group:ETP/near-ETP T-ALL chemotherapy
nonETP-T-ALL-Das Group:nonETP-T-ALL-Das Group chemotherapy with dasatinib
nonETP-T-ALL-HHT Group:nonETP-T-ALL-HHT Group chemotherapy with homoharringtonine
Sponsors
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College.
Eligibility
Sex/Gender
All
Age
1 Months to 18 Years
Inclusion criteria
Inclusion criteria: 1.Must meet all items below: 1)Age older than 1 month to younger 18 years. 2)Diagnosis of acute lymphoblastic leukemia by bone marrow morphology. 3)Diagnosis of T-ALL by immunophenotyping. 4)Written informed consent of the parents or other legally authorized guardian of the patient according to local law and regulations.
Exclusion criteria
Exclusion criteria: 1.Should be excluded if had any item below: 1)B-ALL or AML. 2)Acute leukemias of ambiguous lineage diagnosed according to WHO or EGIL criteria. 3)ALL evolved from chronic myeloid leukemia (CML). 4)Down's syndrome, or major congenital or hereditary disease with organ dysfunction. 5)Secondary lekemia. 6)Known underlying congenital immunodeficiency or metabolic disease. 7)Congenital heart disease with cardiac insufficiency. 8)Treated with glucocorticoids for =14 days, or targeted inhibitor for > 7 days within one month before enrollment, or any chemotherapy or radiotherapy within 3 months before enrollment (except for emergency radiotherapy to relieve airway compression). 9)Any significant comorbidities or psychiatric disorders that may impact patient safety, compliance, informed consent, study participation, follow-up, or the interpretation of study results. In such cases, all participating sites must report directly to the PI to determine whether the patient meets exclusion criteria. 10)Severe malnutrition, active infections, heart failure, or chemotherapy intolerance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| end-of-induction MRD-negativity rate in patients with non-ETP T-ALL;end-of-induction MRD-negativity rate in patients with ETP/near-ETP T-ALL; | — |
Secondary
| Measure | Time frame |
|---|---|
| EFS;OS;CIR;Grade 4 or above complications; | — |
Countries
China
Contacts
Public ContactXiaofan Zhu
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College.
Outcome results
None listed