To evaluate the safety and efficacy of Venetoclax plus IM2 regimen for relapsed and refractory T lymphoblastic lymphoma/leukemia. Dosage of Venetoclax:100mg/d-400mg/d(dose adjustment when concomitant used with CYP3A inhibitor) for 1-28 days (at least 7 days); IM2 regimen: Ifosfamide 1-1.5g/m2/d for 5 days; Mitoxantrone 6-8g/m2/d for 3 days( or Liposome mitoxantrone 20mg/m2 d1 or Idarubicin 6-8mg/m2/d for 3 days) ;methotrexate 1-1.5g/m2/d for 1 day;
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
oral bcl-2 inhibitor plus IM2(Ifosfamide plus Mitoxantrone or Idarubicin plus methotrexate) chemotherapy
Shanghai General hospital,Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
RECRUITINGOverall response rate after 2 cycles of chemotherapy
complete response rate plus partial response rate
Time frame: 2 months after chemotherapy
Overall response rate after 4 cycles of chemotherapy
complete response rate plus partial response rate
Time frame: 4 months after chemotherapy
Grade 3-4 Adverse events incidence
Grade 3-4 Adverse events incidence
Time frame: 28 days after chemotherapy
Overall survival
OS for patients enrolled
Time frame: 12 months
Progression free survival
PFS for patients enrolled
Time frame: 12 months
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