Trial of R-GemOx Versus R-miniCHOP Regimen in First-line Treatment of Elderly Diffuse Large B Cell Lymphoma
Primary Purpose
Diffuse Large B Cell Lymphoma
Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Rituximab
Gemcitabine
Oxaliplatin
Cyclophosphamide
Epirubicin Injectable Product
Vindesine
Prednisone
Sponsored by
About this trial
This is an interventional treatment trial for Diffuse Large B Cell Lymphoma focused on measuring R-Gemox, R-miniCHOP, elderly patients with diffuse large B cell lymphoma
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed diffuse large B cell lymphoma(With exception of Primary mediastinal large B cell lymphoma、Primary central nervous system lymphoma、HIV-related lymphoma);
- New-diagnosed and untreated;
- Age older than 80 years or older than 70 years with ECOG PS ≥ 2;
- Ann Arbor stage I to stage IV disease;
- Understand and voluntarily sign an informed consent form, able to adhere to the study visit schedule and other protocol requirements.
Exclusion Criteria:
- Poor hepatic and/or renal function, defined as total bilirubin, ALT, AST, Cr more than two fold of upper normal level, unless these abnormalities were related to the lymphoma;
- Poor bone-marrow reserve, defined as neutrophil count less than 1.5×10⁹/L or platelet count less than 75×10⁹/L, unless caused by bone marrow infiltration;
- Presence of Grade III nervous toxicity with two weeks;
- New York Heart Association class III or IV cardiac failure; or Ejection fraction less than 50%;or history of following disease in past 6 months: acute coronary syndrome、acute heart failure、severe ventricular arrhythmia
- Positive HIV, syphilis,HCV, or HBV virus load(HBV DNA)> 1×10'4copies/ml;
- CNS or meningeal involvement;
- Concomitant malignancy other than aggressive B cell lymphoma and need to Treat, with the exception of non-melanoma skin tumours or stage 0 (in situ) cervical carcinoma,or history of cancer more than 5 years;
- Concomitant with other hematologic diseases(such as leukemia, hemophilia primary myelofibrosis) which investigator it unsuitable to be enrolled into this clinical trial;
- Active and severe infectious diseases;
- Major surgery within three weeks;
- Any potential drug abuse, medical, psychological or social conditions which may disturb this investigation and assessment.
- In any conditions which investigator considered ineligible for this study.
- Known sensitivity or allergy to investigational Product.
Sites / Locations
- Tongji Medical College of HUSTRecruiting
- The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital)Recruiting
- QiLu Hospital of Shandong UniversityRecruiting
- Shandong Province HospitalRecruiting
- Rui Jin Hospital Shanghai Jiao Tong University School of MedicineRecruiting
- Sudan University Shanghai Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
R-GemOx
R-miniCHOP
Arm Description
Rituximab: 375 mg/m2 IV day0, Gemcitabine 1g/m2 IV day 1, oxaliplatin 100mg/m2 IV day1(every 14 days)
Rituximab, 375 mg/m2 IV d0 Cyclophosphamide 400 mg/m2 IV d1 Epirubicin 35 mg/m2 IV d1 vindesine 2 mg IVP d1 Prednisone 40mg/m2 PO d1-5(every 21 days a cycle)
Outcomes
Primary Outcome Measures
2-year overall survival rate
from the date of inclusion to date of death, irrespective of cause
Secondary Outcome Measures
2-year progression free survival rate
from date of inclusion to date of progression, relapse, or death from any causePFS:from date of inclusion to date of progression, relapse, or death from any cause
overall response rate
overall response rate after treated by R-GemOx or R-miniCHOP overall response rate after treated by R-GemOx or R-miniCHOP regimen
Full Information
NCT ID
NCT02767674
First Posted
May 7, 2016
Last Updated
January 1, 2019
Sponsor
The First Affiliated Hospital with Nanjing Medical University
1. Study Identification
Unique Protocol Identification Number
NCT02767674
Brief Title
Trial of R-GemOx Versus R-miniCHOP Regimen in First-line Treatment of Elderly Diffuse Large B Cell Lymphoma
Official Title
Phase III,Randomized Controlled Trial of R-GemOx Versus R-miniCHOP Regimen in First-line Treatment of Elderly Diffuse Large B Cell Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 2016 (undefined)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First Affiliated Hospital with Nanjing Medical University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to investigate efficacy and safety of R-GemOx Versus R-miniCHOP as first-line treatment of elderly patients with Diffuse large B cell lymphoma
Detailed Description
Gemcitabine and Oxaliplatin(GemOx) shows effective activity in patients with relapsed diffuse large-cell lymphoma and other solid tumors. Our Previous study showed that two-weekly regimen of rituximab combined with GemOx regimen acheived comparable response rate to R-miniCHOP.The investigators therefore design this open-label,phase III and random trial to compared the safety and efficacy of R-Gemox versus R-miniCHOP as first-line treatment of elderly patients with diffuse large B cell lymphoma.
Primary Outcome Measures:
• 2-year overall survival rate
Secondary Outcome Measures:
2-year progression free survival rate
overall response rate
safety and toxicity Enrollment:258 Study Start Date: June 2016 Primary Completion Date: June 2019
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diffuse Large B Cell Lymphoma
Keywords
R-Gemox, R-miniCHOP, elderly patients with diffuse large B cell lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
258 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
R-GemOx
Arm Type
Experimental
Arm Description
Rituximab: 375 mg/m2 IV day0, Gemcitabine 1g/m2 IV day 1, oxaliplatin 100mg/m2 IV day1(every 14 days)
Arm Title
R-miniCHOP
Arm Type
Active Comparator
Arm Description
Rituximab, 375 mg/m2 IV d0 Cyclophosphamide 400 mg/m2 IV d1 Epirubicin 35 mg/m2 IV d1 vindesine 2 mg IVP d1 Prednisone 40mg/m2 PO d1-5(every 21 days a cycle)
Intervention Type
Drug
Intervention Name(s)
Rituximab
Intervention Description
375 mg/m2 IVD day0
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
Gemcitabine 1 g/m2 IVD day 1
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Intervention Description
Oxaliplatin 100 mg/m2 IVD day1
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
Cyclophosphamide 400 mg/m2 IVD d1
Intervention Type
Drug
Intervention Name(s)
Epirubicin Injectable Product
Intervention Description
Epirubicin 35 mg/m2 IVD d1
Intervention Type
Drug
Intervention Name(s)
Vindesine
Intervention Description
Vindesine 2 mg IVP d1
Intervention Type
Drug
Intervention Name(s)
Prednisone
Intervention Description
Prednisone 40mg/m2 PO d1-5
Primary Outcome Measure Information:
Title
2-year overall survival rate
Description
from the date of inclusion to date of death, irrespective of cause
Time Frame
One year
Secondary Outcome Measure Information:
Title
2-year progression free survival rate
Description
from date of inclusion to date of progression, relapse, or death from any causePFS:from date of inclusion to date of progression, relapse, or death from any cause
Time Frame
One year
Title
overall response rate
Description
overall response rate after treated by R-GemOx or R-miniCHOP overall response rate after treated by R-GemOx or R-miniCHOP regimen
Time Frame
One year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed diffuse large B cell lymphoma(With exception of Primary mediastinal large B cell lymphoma、Primary central nervous system lymphoma、HIV-related lymphoma);
New-diagnosed and untreated;
Age older than 80 years or older than 70 years with ECOG PS ≥ 2;
Ann Arbor stage I to stage IV disease;
Understand and voluntarily sign an informed consent form, able to adhere to the study visit schedule and other protocol requirements.
Exclusion Criteria:
Poor hepatic and/or renal function, defined as total bilirubin, ALT, AST, Cr more than two fold of upper normal level, unless these abnormalities were related to the lymphoma;
Poor bone-marrow reserve, defined as neutrophil count less than 1.5×10⁹/L or platelet count less than 75×10⁹/L, unless caused by bone marrow infiltration;
Presence of Grade III nervous toxicity with two weeks;
New York Heart Association class III or IV cardiac failure; or Ejection fraction less than 50%;or history of following disease in past 6 months: acute coronary syndrome、acute heart failure、severe ventricular arrhythmia
Positive HIV, syphilis,HCV, or HBV virus load(HBV DNA)> 1×10'4copies/ml;
CNS or meningeal involvement;
Concomitant malignancy other than aggressive B cell lymphoma and need to Treat, with the exception of non-melanoma skin tumours or stage 0 (in situ) cervical carcinoma,or history of cancer more than 5 years;
Concomitant with other hematologic diseases(such as leukemia, hemophilia primary myelofibrosis) which investigator it unsuitable to be enrolled into this clinical trial;
Active and severe infectious diseases;
Major surgery within three weeks;
Any potential drug abuse, medical, psychological or social conditions which may disturb this investigation and assessment.
In any conditions which investigator considered ineligible for this study.
Known sensitivity or allergy to investigational Product.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Huayuan Zhu, M.D., Ph.D.
Phone
+86 68136034
Email
huayuan.zhu@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Wei Xu, M.D., Ph.D.
Phone
+86 68136034
Email
xuwei10000@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei Xu, M.D., Ph.D.
Organizational Affiliation
The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tongji Medical College of HUST
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianfeng Zou
Facility Name
The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital)
City
NanJing
State/Province
Jiangsu
ZIP/Postal Code
21002
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huayuan Zhu, M.D., Ph.D.
Phone
+86 68136034
Email
huayuan.zhu@hotmail.com
First Name & Middle Initial & Last Name & Degree
Wei Xu, M.D., Ph.D.
Facility Name
QiLu Hospital of Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luqun Wang, M.D., Ph.D.
Facility Name
Shandong Province Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xin Wang, M.D., Ph.D.
Facility Name
Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weili Zhao, M.D., Ph.D.
Facility Name
Sudan University Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200433
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ye Guo, M.D., Ph.D.
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
11807147
Citation
Coiffier B, Lepage E, Briere J, Herbrecht R, Tilly H, Bouabdallah R, Morel P, Van Den Neste E, Salles G, Gaulard P, Reyes F, Lederlin P, Gisselbrecht C. CHOP chemotherapy plus rituximab compared with CHOP alone in elderly patients with diffuse large-B-cell lymphoma. N Engl J Med. 2002 Jan 24;346(4):235-42. doi: 10.1056/NEJMoa011795.
Results Reference
result
PubMed Identifier
17785567
Citation
Oyama T, Yamamoto K, Asano N, Oshiro A, Suzuki R, Kagami Y, Morishima Y, Takeuchi K, Izumo T, Mori S, Ohshima K, Suzumiya J, Nakamura N, Abe M, Ichimura K, Sato Y, Yoshino T, Naoe T, Shimoyama Y, Kamiya Y, Kinoshita T, Nakamura S. Age-related EBV-associated B-cell lymphoproliferative disorders constitute a distinct clinicopathologic group: a study of 96 patients. Clin Cancer Res. 2007 Sep 1;13(17):5124-32. doi: 10.1158/1078-0432.CCR-06-2823.
Results Reference
result
PubMed Identifier
21482186
Citation
Peyrade F, Jardin F, Thieblemont C, Thyss A, Emile JF, Castaigne S, Coiffier B, Haioun C, Bologna S, Fitoussi O, Lepeu G, Fruchart C, Bordessoule D, Blanc M, Delarue R, Janvier M, Salles B, Andre M, Fournier M, Gaulard P, Tilly H; Groupe d'Etude des Lymphomes de l'Adulte (GELA) investigators. Attenuated immunochemotherapy regimen (R-miniCHOP) in elderly patients older than 80 years with diffuse large B-cell lymphoma: a multicentre, single-arm, phase 2 trial. Lancet Oncol. 2011 May;12(5):460-8. doi: 10.1016/S1470-2045(11)70069-9. Epub 2011 Apr 7.
Results Reference
result
PubMed Identifier
18005385
Citation
Lopez A, Gutierrez A, Palacios A, Blancas I, Navarrete M, Morey M, Perello A, Alarcon J, Martinez J, Rodriguez J. GEMOX-R regimen is a highly effective salvage regimen in patients with refractory/relapsing diffuse large-cell lymphoma: a phase II study. Eur J Haematol. 2008 Feb;80(2):127-32. doi: 10.1111/j.1600-0609.2007.00996.x. Epub 2007 Nov 20.
Results Reference
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PubMed Identifier
21940215
Citation
Cabanillas F. Rituximab in DLBCL: 6 years on. Lancet Oncol. 2011 Oct;12(11):984-5. doi: 10.1016/S1470-2045(11)70251-0. Epub 2011 Sep 21. No abstract available.
Results Reference
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PubMed Identifier
17400912
Citation
Park S, Lee J, Ko YH, Han A, Jun HJ, Lee SC, Hwang IG, Park YH, Ahn JS, Jung CW, Kim K, Ahn YC, Kang WK, Park K, Kim WS. The impact of Epstein-Barr virus status on clinical outcome in diffuse large B-cell lymphoma. Blood. 2007 Aug 1;110(3):972-8. doi: 10.1182/blood-2007-01-067769. Epub 2007 Mar 30.
Results Reference
result
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Trial of R-GemOx Versus R-miniCHOP Regimen in First-line Treatment of Elderly Diffuse Large B Cell Lymphoma
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