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

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ClinicalTrials.gov Identifier: NCT03151044
Recruitment Status : Recruiting
First Posted : May 12, 2017
Last Update Posted : May 12, 2017
Sponsor:
Collaborator:
Chinese Anti-Cancer Association
Information provided by (Responsible Party):
FENG Ji-feng, Jiangsu Cancer Institute & Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Diffuse Large B-cell Lymphoma Drug: High-dose Epirubicin Combined with CVP ± Rituximab Drug: Standard-dose Epirubicin Combined with CVP ± Rituximab Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 408 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Open, Randomized Controlled, Multi-center Phase III Clinical Trial Comparing High-dose Epirubicin and Standard-dose Epirubicin in R±CEOP in Newly Diagnosed Young Patients With Medium/High-risk Diffuse Large B-cell Lymphoma
Actual Study Start Date : July 2016
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : July 2017


Arm Intervention/treatment
Experimental: EPI-90

Participants in this arm shall be given high-dose Epirubicin Combined with CVP ± Rituximab for six 21-day cycles:

High-dose Epirubicin 90mg/m2, i.v., Day 1; Cyclophosphamide 750mg/m2, i.v., Day 1; Vincristine 1.4mg/m2, i.v., Day 1; Prednisolone 100mg/m2, p.o., Day 1-5;

Plus/not plus:

Rituximab 375mg/m2, i.v., Day 0

Drug: High-dose Epirubicin Combined with CVP ± Rituximab
Experimental group shall be given high-dose Epirubicin (90mg/m2) combined with standard-dose Cyclophosphamide (750mg/m2), Vincristine (1.4mg/m2) and Prednisolone (100mg/m2) ± Rituximab
Other Name: R±CEOP90

Active Comparator: EPI-75

Participants in this arm shall be given standard-dose Epirubicin, Combined with CVP ± Rituximab for six 21-day cycles:

Standard-dose Epirubicin 75mg/m2, i.v., Day 1; Cyclophosphamide 750mg/m2, i.v., Day 1; Vincristine 1.4mg/m2, i.v., Day 1; Prednisolone 100mg/m2, p.o., Day 1-5;

Plus/not plus:

Rituximab 375mg/m2, i.v., Day 0

Drug: Standard-dose Epirubicin Combined with CVP ± Rituximab
Active comparator group shall be given standard-dose Epirubicin and standard-dose Cyclophosphamide (750mg/m2), Vincristine (1.4mg/m2) and Prednisolone (100mg/m2) ± Rituximab
Other Name: R±CEOP75




Primary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: up to 2 years ]
    Percentage of Complete remission (CR), Unconfirmed Complete Remission (CRu) and Partial remission (PR), referred to 2007 Cheson's Response Criteria for Lymphoma


Secondary Outcome Measures :
  1. Time to response (TRR) [ Time Frame: From date of drug administration until the date of the first remission (including Complete remission, Unconfirmed Complete Remission and Partial remission, whichever came first), assessed up to 2 years ]
    The time from drug administration to the first remission (including the first PR, CRu and CR)

  2. Duration of response (DOR) [ Time Frame: From date of the first remission until the date of first documented progression, assessed up to 2 years ]
    The time from remission to the first disease progression

  3. Progression-free survival (PFS) [ Time Frame: From date of drug administration until the date of progression disease or death, whichever came first, assessed up to 2 years ]
    The time from drug administration to the first progression disease or death

  4. Overall survival(OS) [ Time Frame: From date of drug administration until the date of death, assessed up to 2 years ]
    The time from drug administration to death



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03151044


Contacts
Contact: Jianqiu Wu, Master 8613951671579 drwujq@vip.126.com
Contact: Jifeng Feng, M.D. 8613901581264 fjif@vip.sina.com

Locations
China, Jiangsu
Changzhou No.2 People's Hospital Recruiting
Changzhou, Jiangsu, China, 213003
Contact: Xuzhang Lu, M.D.    8615295189493    luxuzhang2008@163.com   
Principal Investigator: Xuzhang Lu, M.D.         
Jiangyin People's hospital Recruiting
Jiangyin, Jiangsu, China, 214400
Contact: Dong Shen, M.D.    8615961663515    sdshendong@126.com   
Principal Investigator: Dong Shen, M.D.         
Nanjing General Hospital Recruiting
Nanjing, Jiangsu, China, 210002
Contact: Jinghua Wang, M.D.    8613951740778    jinghua56@sina.com   
Principal Investigator: Jinghua Wang, M.D.         
Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School Recruiting
Nanjing, Jiangsu, China, 210008
Contact: Jingyan Xu, M.D.    8613951969610    xiy1967@sina.com   
Principal Investigator: Jingyan Xu, M.D.         
Jiangsu Cancer Institute and Hospital Recruiting
Nanjing, Jiangsu, China, 210009
Contact: Jianqiu Wu, M.D.    8613951671579    drwujq@vip.126.com   
Contact: Jifeng Feng, M.D.    8613901581264    fjif@vip.sina.com   
Principal Investigator: Jifeng Feng, M.D.         
Jiangsu Province Hospital Recruiting
Nanjing, Jiangsu, China, 210029
Contact: Xuemei Sun, M.D.    8613913911666    13913911666@qq.com   
Principal Investigator: Xuemei Sun, M.D.         
Nantong Tumor Hospital Recruiting
Nantong, Jiangsu, China, 226361
Contact: Xiaohong Xu, M.D.    8618912296003    xhx107@163.com   
Principal Investigator: Xiaohong Xu, M.D.         
Wuxi People's hospital Recruiting
Wuxi, Jiangsu, China, 214023
Contact: Xin Zhou, M.D.    8613358111962    13358111962@189.cn   
Principal Investigator: Xin Zhou, M.D.         
Northern Jiangsu People's Hospital Recruiting
Yangzhou, Jiangsu, China, 225001
Contact: Bin He, M.D.    8618932371190    yzhebin2013@qq.com   
Principal Investigator: Bin He, M.D.         
Sponsors and Collaborators
FENG Ji-feng
Chinese Anti-Cancer Association
Investigators
Principal Investigator: Jifeng Feng, M.D. Jiangsu Cancer Institute and Hospital

Publications:

Responsible Party: FENG Ji-feng, Director of the hospital, Jiangsu Cancer Institute & Hospital
ClinicalTrials.gov Identifier: NCT03151044     History of Changes
Other Study ID Numbers: 2015NL-078
First Posted: May 12, 2017    Key Record Dates
Last Update Posted: May 12, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by FENG Ji-feng, Jiangsu Cancer Institute & Hospital:
epirubicin
high-dose
Diffuse Large B-cell Lymphoma
medium/high-risk

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Cyclophosphamide
Rituximab
Vincristine
Prednisolone
Methylprednisolone Hemisuccinate
Epirubicin
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists