Pegylated Liposomal Doxorubicin-contained Versus Daunorubicin-contained VDCLD Regimen in Previously Untreated Adult Patients With Acute Lymphoblastic Leukemia: Complete Remission Rates and Changes of Leukemia Stem Cells
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Complete remission (CR) rates after the first course of regimen
研究概览
简要总结
To determine, compared with Daunorubicin(DNR), whether Pegylated liposomal doxorubicin (PLD) inducing higher complete remission (CR) rate, in untreated primary ALL adult patients with VDCLD regimen induction therapy. Second, to determine, compared with the DNR, whether chemotherapy containing PLD with a higher response rates and greater safety in adult ALL
详细描述
This is a prospective, multicenter, open, non-intervention clinical study, with estimated enrollment of 200 newly diagnosed adult ALL patients. After the first course of treatment administered with PLD-contained or DNR-contained VDCLD regimen, CR rate and changes of leukemia stem cells in bone marrow, was evaluated; the safety of these chemotherapy was also evaluated.
Study Patients:
Patients included in this study should be untreated with ALL previously, being in line with the inclusion criteria and exclusion criteria.
Dosage and Administration:
PLD-contained VDCLD regimen：PLD 36 mg/m2 ivdrip over 60 minutes( d1、15),VCR 1.4mg/m iv(d1，8，15，22), CTX 800 mg/m2 ivdrip( d1), L-asp 6000u/m2 ivdrip(d19～28),Dex10mg ivdrip (d1～28).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible men or women were age over 14，but less than 60 years;
- •Eastern Cooperative Oncology Group performance status of 0 to2;
- •Diagnosed with ALL (WHO classification, the primitive cells ≥ 20%);
- •Previous untreated ALL patients had not received chemotherapy before (excluding dexamethasone, prednisone, and hydroxyurea). History of receiving blood transfusion, hematopoietic growth factors, vitamin, and palliative measures such as leukocyte removal, dexamethasone, prednisone, hydroxyurea (0.5-3g daily, more than three days) is allowed;
- •The levels of LSCs in bone marrow were measured with flow cytometry before treatment;
- •Subjects must be able to provide written informed consent.
排除标准
- •Mixed type of AL patients;
- •Clinically significant active infections;
- •Nursing (breastfeeding) or intending to be nursing during the study；
- •Pregnancy, or intending to become pregnant during the study;
- •Patients with cardiac dysfunction currently (especially congestive heart failure) or history of congestive heart failure;
- •Patients with severe liver failure (ALT ≥ 5 times the upper limit of normal (ULN), total bilirubin ≥ 3mg/dL)
- •Patients with renal insufficiency, creatinine clearance <30ml/min, creatinine clearance rate is calculated as follows: Men: Ccr (ml / min) = (140 - age) × weight (kg) / [0.8136 × serum creatinine (μmol / L )] female: Ccr (ml / min) = (140 - age) × weight (kg) × 0.85 / [0.8136 × serum creatinine (μmol / L)];
- •Patients did not or will not participate in other trials of drugs 30 days before or 90 days after the beginning of this study,
研究组 & 干预措施
PLD-contained VDCLD regimen
PLD 36 mg/m2 ivdrip over 60 minutes( d1、15),VCR 1.4mg/m iv(d1，8，15，22), CTX 800 mg/m2 ivdrip( d1), L-asp 6000u/m2 ivdrip(d19～28),Dex10mg ivdrip (d1～28).
干预措施: VDCLD regimen (Drug)
DNR-contained VDCLD regimen
DNR 45 mg/m2 ivdrip over 60 minutes(d1～3),VCR 1.4mg/m2 iv(d1，d8，d15，d22), CTX 800 mg/m2 ivdrip(d1), L-asp 6000u/m2 ivdrip(d19～28),Dex10mg ivdrip(d1～28).
干预措施: VDCLD regimen (Drug)
结局指标
主要结局
Complete remission (CR) rates after the first course of regimen
时间窗: 3 years after the last enrollment
The primary endpoint of the study was complete remission (CR) rates after the first course of regimen. The proportion of patients achieved CR was evaluated, after the first course of induction chemotherapy administered with PLD-contained or DNR-contained VDCLD regimen
次要结局
- The change of leukemia stem cells in bone marrow(3 years after the last enrollment)