Trials / Unknown
UnknownNCT03419494
Comparison of Liposomal Doxorubicin and Daunorubicin-containing VDCLD Regimen in the Treatment of Adult ALL Patients
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
- Phase
- —
- Study type
- Observational
- Enrollment
- 40 (estimated)
- Sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Industry
- Sex
- All
- Age
- 14 Years – 60 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | PLD | PLD36mg/m2.d d1、d15，ivdrip，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 |
| DRUG | DNR | DNR 45mg/m2.d d1～3，ivdrip，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 |
Timeline
- Start date
- 2013-10-10
- Primary completion
- 2019-01-31
- Completion
- 2019-06-30
- First posted
- 2018-02-05
- Last updated
- 2018-02-05
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03419494. Inclusion in this directory is not an endorsement.