This trial is a multicenter prospective, open, non-intervention clinical study. 200 patients with newly diagnosed adult ALL who underwent induction remission with the VDCLD regimen containing PLD and DNR, respectively,were plan to enrolled in this study to evaluate the CR rate and the level of myeloid leukemia stem cells in the first course of chemotherapy with two regimens; and to evaluate the safety of the two induction chemotherapy regimens.
Subjects will receive one of two treatment regimens: Group A: intravenous drip of liposomal doxorubicin 36 mg/m2, d1、d15,1h; VCR 1.4mg/m2.d d1,d8,d15,d22 iv,CTX 800mg/m2.d d1 ivdrip,L-asp 6000u/m2.d d19~28 ivdrip,Dex10mg.d d1~28 ivdrip,once every 28days. Group B: intravenous drip of DNR45mg/m2,d d1~3,1h;VCR 1.4mg/m2.d d1,d8,d15,d22 iv,CTX 800mg/m2.d d1 ivdrip,L-asp 6000u/m2.d d19~28 ivdrip,Dex10mg.d d1~28 ivdrip,once every 28days. The primary endpoint is complete remission after the first course treatment of induced remission chemotherapy, to evaluated the ratio of CR patients after the first course of chemotherapy with PLD and DNR VDCLD regimens.The secondary endpoint is to evaluate the changes of myeloid leukemia stem cells in patients before and after induction of VDCLD with PLD and DNR respectively.
Study Type
OBSERVATIONAL
Enrollment
40
Affiliated Hospital of Guangdong Medical University
Guangdong, Guangdong, China
RECRUITINGCR
complete remission after the first course treatment of induced remission chemotherapy
Time frame: From date of randomization until the date of first course of chemotherapy treatment completed, assessed up to 4 weeks.
changes of myeloid leukemia stem cells
to evaluate the changes of myeloid leukemia stem cells in patients before and after induction of VDCLD with PLD and DNR respectively.
Time frame: From date of randomization until the date of first course of chemotherapy treatment completed, assessed up to 4 weeks.
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