Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-25 @ 11:38 PM
Study NCT ID:
NCT03419494
Status:
UNKNOWN
Last Update Posted:
2018-02-05
First Post:
2018-01-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Liposomal Doxorubicin and Daunorubicin-containing VDCLD Regimen in the Treatment of Adult ALL Patients
Sponsor:
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Organization:
Study Overview
Official Title:
Comparison of Remission Rate and Leukemic Stem Cell Changes Among Patients With Newly Diagnosed Adult ALL With Liposomal Doxorubicin and Daunorubicin-containing VDCLD Regimen.
Status:
UNKNOWN
Status Verified Date:
2018-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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.
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: