The purpose of this study is to evaluate the efficacy and safety of decitabine combined with HAAG regimen in the treatment of newly diagnosed patients with ETP-ALL/LBL, T/M-MPAL and ALL/LBL with myeloid or stem cell markers.
This is a phase 3, open label, single arm, multi-center study in newly diagnosed ETP-ALL/LBL, T/M-MPAL and ALL/LBL patients who have myeloid or stem cell markers. The patients will receive decitabine combined with HAAG regimen in the induction treatment. The patients who respond to induction chemotherapy will undergo consolidation chemotherapy, and an optional allogeneic hematopoietic stem cell transplantation and post-transplantation maintenance treatment with decitabine according to patient's wishes.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Decitabine :20mg/m2/d,d1\~5, intravenous infusion; Homoharringtonine :1mg/d,d3\~16,intravenous infusion; Aclarubicin :10mg/d, d3\~d10, intravenous infusion; Cytarabine :10mg/m2,q12h,d3-16, subcutaneous injection; Granulocyte colony-stimulating factor (G-CSF): 50-300μg/d (when WBC counts are less than 20×10\^9/L ),subcutaneous injection
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
RECRUITINGOverall Response Rate (ORR)
ORR includes complete remission (CR), CR with incomplete hematologic recovery (CRi) and partial remission (PR). CR was defined as \< 5% bone marrow blasts in an aspirate with spicules and independent of transfusions; CRi: was defined as\<5% bone marrow blasts, either ANC\<1×10\^9/L or platelets\<100×10\^9/L, transfusion independence but with persistence of cytopenia; PR was defined as decrease of at least 50% in the percentage of blasts to 5-25% in the bone marrow aspirate and the normalization of blood counts.
Time frame: Day 28-35 of induction course
Overall survival (OS)
time from randomization to death from any cause
Time frame: 4 years
Leukemia-free survival (LFS)
time from randomization to the first relapse or death
Time frame: 4 years
Cumulative incidence of relapse(CIR)
time from achievement of a remmission to the first relapse
Time frame: 4 years
Number of adverse events
adverse events are evaluated with CTCAE V5.0.
Time frame: 3 years
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