Status:
UNKNOWN
Comparison of Liposomal Doxorubicin and Daunorubicin-containing VDCLD Regimen in the Treatment of Adult ALL Patients
Lead Sponsor:
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Conditions:
Adult Acute Lymphoblastic Leukemia
Eligibility:
All Genders
14-60 years
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 ...
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 ...
Eligibility Criteria
Inclusion
- Male or female, age:14-60 years old; 2.ECOG score 0-2; 3.Subjects had confirmed ALL (WHO classification, primitive cells ≥ 20%); 4.Patients with newly diagnosed ALL who have not previously received chemotherapy (except for dexamethasone, prednisone, hydroxyurea).Blood transfusion, use of hematopoietic growth factors or vitamins are allowed. Some temporary measures such as leukocyte removal, dexamethasone, prednisone, hydroxyurea (0.5-3g daily, over 3 days) are allowed; 5.Flow cytometry was used to detect leukemic stem cells in bone marrow samples before treatment; 6.Informed consent (all studies must be signed patient informed consent).
Exclusion
- Mixed AL patients; 2.Active systemic infection; 3.Lactating women, fertile women with positive pregnancy tests for urine or pregnant women who are unwilling to adopt appropriate methods of contraception (such as the use of birth control pills, intrauterine devices, diaphragms, abstinence, condom use) during the study ; 4. Patients currently have a history of cardiac insufficiency (especially congestive heart failure) or previous history of congestive heart failure; 5. Patients with severe liver failure (≥5 times upper limit of normal transaminase, total bilirubin ≥3 mg/dL); 6. Patients had renal insufficiency with creatinine clearance \<30 ml/min and creatinine clearance calculated as follows: Male: Ccr (ml / min) = (140-age) × body weight (kg) / \[0.8136 × serum creatinine (μmol/L)\] women: Ccr (ml/min) = (140-age) × body weight (kg) × 0.85 / \[0.8136 × serum creatinine (μmol/L)\]; 7. Patient is involved in other drugs experimental study within 30 days prior to the trial or within 90 days of the start of the trial; 8. Researchers think it is not suitable for enrolling.
Key Trial Info
Start Date :
October 10 2013
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2019
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03419494
Start Date
October 10 2013
End Date
June 30 2019
Last Update
February 5 2018
Active Locations (1)
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1
Affiliated Hospital of Guangdong Medical University
Guangdong, Guangdong, China, 524001