In this prospective, single arm, open label, clinical trial, a total of 50 acute leukemia of ambiguous lineage patients will be enrolled. Patients will receive acute lymphoblastic leukemia (ALL) -based chemotherapy and are permitted to receive allogeneic hematopoietic stem cell transplantation (HSCT) after CR . Otherwise, they will finish the consolidation chemotherapy. Patients with t(9;22) will receive chemotherapy combined with tyrosine kinase inhibitors. The purpose of current study is to evaluate the clinical efficacy of ALL-based chemotherapy，effect of genetic abnormality and minimal residual disease (MRD) on prognosis in patients with acute leukemia of ambiguous lineage.
Patients aged above 14 years with acute leukemia of ambiguous lineage .
Eastern Cooperative Oncology Group (ECOG) Performance status 2.
Adequate end organ function as defined by: Total bilirubin ≤ 1.5 x upper limit of normal (ULN); serum glutamic-oxaloacetic transaminase(SGOT) and serum glutamic pyruvic transaminase(SGPT) ≤ 2.5 x ULN; Creatinine ≤ 1.5 x ULN; Serum amylase and lipase ≤ 1.5 x ULN; Alkaline phosphatase ≤ 2.5 x ULN unless considered tumor related; Patients must have adequate cardiac function (ejection fraction ≥ 45 % on Multiple Gated Acquisition (MUGA) scan).
Patients must have the following laboratory values (≥ lower limit of normal (LLN) or corrected to within normal limits with supplements prior to the first dose of study medication.): Potassium ≥ LLN; Magnesium ≥ LLN; Phosphorus ≥ LLN
Patients who are: (a) pregnant and (b) breast feeding.
Single group
vincristine
Drugacute lymphoblastic leukemia (ALL) -based chemotherapy
daunorubicin
Drugacute lymphoblastic leukemia (ALL) -based chemotherapy
cyclophosphamide
Drugacute lymphoblastic leukemia (ALL) -based chemotherapy
L-Asparaginase
Drugacute lymphoblastic leukemia (ALL) -based chemotherapy
prednisone
Drugacute lymphoblastic leukemia (ALL) -based chemotherapy
mercaptopurine
Drugacute lymphoblastic leukemia (ALL) -based chemotherapy
methotrexate
Drugacute lymphoblastic leukemia (ALL) -based chemotherapy
dexamethasone
Drugacute lymphoblastic leukemia (ALL) -based chemotherapy
Tyrosine kinase inhibitor
Drugacute lymphoblastic leukemia (ALL) -based chemotherapy
Overall survival (OS)
From the date of diagnosis until the date of death from any cause,
Relapse free survival (RFS)
From the date of CR until the date of relapse or death
The complete remission (CR) rate
Incidence of complete remission after induction chemotherapy
Mortality within 60 days
Proportion of patients died within 60 days
Chromosomal abnormalities detected by G-banding
Fusion genes detected by polymerase chain reaction
Mutations detected by next-generation sequencing
Minimal residual disease（MRD）
The presence of small numbers of leukemic cells detected by the flow cytometry after remission
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