Pegylated Liposomal Doxorubicin Versus Daunorubicin to Treat Acute Lymphoblastic Leukemia: (NCT02070523) | Clinical Trial Compass
UnknownPhase 3
Pegylated Liposomal Doxorubicin Versus Daunorubicin to Treat Acute Lymphoblastic Leukemia:
China200 participantsStarted 2013-12
Plain-language summary
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
Who can participate
Age range14 Years – 60 Years
SexALL
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Inclusion Criteria:
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.
Exclusion Criteria:
Mixed type of AL patients;
Clinically significant active infections;
Nursing (breastfeeding) or intending to be nursing during the studyï¼›
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 o…
What they're measuring
1
Complete remission (CR) rates after the first course of regimen