R±CEOP90 Versus R±CEOP75 in Newly Diagnosed Young Patients With Medium/High-risk DLBCL

• Status: Unknown status
• Trial end date: 2017-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This clinical trial is designed to compare the efficacy and safety of R±CEOP90 containing high-dose epirubicin and R±CEOP75 containing standard epirubicin in newly diagnosed young patients with medium/high-risk diffuse large B-cell lymphoma. Half of the participants receive R±CEOP regimen containing 90mg/m2 epirubicin, while the other half of participants receive R±CEOP regimen containing 75mg/m2 epirubicin. Via exploring whether high-dose epirubicin shall achieve better efficacy and less toxicity, we hope to optimize current treatment choice for young patients with medium/high-risk diffuse large B-cell lymphoma.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: FENG Ji-feng
• Collaborator: Chinese Anti-Cancer Association
• Treatments: Cyclophosphamide; Epirubicin; Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Rituximab; Vincristine

Criteria

Inclusion Criteria:

1. All newly diagnosed patients with histologically proven diffuse large B cell lymphoma (DLBCL);

2. There is at least one measurable tumor mass (physical examined long diameter of mass over 2 cm, or 5mmCT-scanned long diameter of mass over 1.5cm and short diameter over 1.0cm);

3. Male or female patients aged no younger than 18 and no elder than 60 years old;

4. aaIPI≥2 (LDH > normal +ECOG ≤2 + stage III-IV);

5. No involvement of the central nervous system;

6. ECOG score ≤ 2 points and expected survival ≥3 months;

7. During the study period, female subjects must be in menopause, or sterilization or willing to take contraceptive measures. Women with childbearing potential must use medically acceptable contraceptive method and agree to use this contraceptive method 2 weeks before treatment of the study drug, during study drug treatment and 3 months after the completion of study drug treatment;

8. Male subjects are required to take contraceptive measures and agree to use this contraceptive method 2 weeks before treatment of the study drug, during study drug treatment and 3 months after the completion of study drug treatment.

9. The subjects must be able to understand the study and are willing to participate in the study and sign informed consent;

10. The subjects must be able and willing to follow the research plan

11. Echocardiography measured LVEF ≥ 50%

12. Satisfied hematological function (based on the investigator's judgment, except for the DLBCL abnormal conditions) is defined as follows: Hemoglobin ≥9g/dl; absolute neutrophil count ≥1.5 * 10^9/L; platelet count ≥75 * 10^9/L

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Exclusion Criteria:

1. Primary central nervous system tumors or central nervous system metastasis;

2. previous drug induced cardiotoxicity > =CTCAE 3.0 Grade 2;

3. Complicated with serious heart disease which may affect this clinical study (e.g., heart failure [New York Heart Association NYHA Class III or IV, or left ventricular ejection fraction LVEF<50%] or with disease history of following diseases: QTc prolongation of clinical significance (for male patients, QTc over 450ms; for female patients, QTc over 470ms), ventricular tachycardia (VT) , atrial fibrillation (AF), heart block, myocardial infarction (MI) within 1 years, congestive heart failure (CHF) and coronary heart disease with symptoms requiring drug treatment;

4. Diagnosis of other malignancies other than diffuse large B cell lymphoma (DLBCL);

5. Mental disorders affecting compliance;

6. Unable to obtain informed consent;

7. Previously have received DLBCL treatment, except for biopsy or local radiotherapy;

8. Patients are pregnant or lactating women;

9. Patients have severe infections, medical conditions or psychiatric conditions, and investigators believe that this condition may interfere with the purpose of the study;

10. Patients with known positive human immunodeficiency virus (HIV), active hepatitis B, or active hepatitis C (positive for anti-HCV antibodies);

11. Existence of following laboratory abnormalities (unless any of these abnormalities are due to underlying lymphoma):

1. Creatinine was greater than 1.5 folds of upper limit of normal (ULN) (except that creatinine clearance is within normal range) or calculated creatinine clearance<40 mL/min (using Cockcroft - Gault formula)

2. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 folds of ULN

3. Total bilirubin ≥1.5 folds of ULN: if total bilirubin ≤ 3 folds of ULN, patients with diagnosed Gilbert's disease can be included

12. In the absence of anticoagulant therapy, the international normalized ratio (INR) > 1.5 folds of ULN

13. In lupus patients without anticoagulant drug treatment, partial thromboplastin time (PTT) and activated partial thromboplastin time (aPTT) > 1.5 folds of ULN

14. Investigators decide that the patient is not suitable for this study