Trial of R-GemOx Versus R-miniCHOP Regimen in First-line Treatment of Elderly Diffuse Large B Cell Lymphoma
NCT ID: NCT02767674
Last Updated: 2019-01-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
258 participants
INTERVENTIONAL
2016-05-31
2020-12-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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R-GemOx
Rituximab: 375 mg/m2 IV day0, Gemcitabine 1g/m2 IV day 1, oxaliplatin 100mg/m2 IV day1(every 14 days)
Rituximab
375 mg/m2 IVD day0
Gemcitabine
Gemcitabine 1 g/m2 IVD day 1
Oxaliplatin
Oxaliplatin 100 mg/m2 IVD day1
R-miniCHOP
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)
Rituximab
375 mg/m2 IVD day0
Cyclophosphamide
Cyclophosphamide 400 mg/m2 IVD d1
Epirubicin Injectable Product
Epirubicin 35 mg/m2 IVD d1
Vindesine
Vindesine 2 mg IVP d1
Prednisone
Prednisone 40mg/m2 PO d1-5
Interventions
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Rituximab
375 mg/m2 IVD day0
Gemcitabine
Gemcitabine 1 g/m2 IVD day 1
Oxaliplatin
Oxaliplatin 100 mg/m2 IVD day1
Cyclophosphamide
Cyclophosphamide 400 mg/m2 IVD d1
Epirubicin Injectable Product
Epirubicin 35 mg/m2 IVD d1
Vindesine
Vindesine 2 mg IVP d1
Prednisone
Prednisone 40mg/m2 PO d1-5
Eligibility Criteria
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Inclusion Criteria
2. New-diagnosed and untreated;
3. Age older than 80 years or older than 70 years with ECOG PS ≥ 2;
4. Ann Arbor stage I to stage IV disease;
5. Understand and voluntarily sign an informed consent form, able to adhere to the study visit schedule and other protocol requirements.
Exclusion Criteria
2. 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;
3. Presence of Grade III nervous toxicity with two weeks;
4. 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
5. Positive HIV, syphilis,HCV, or HBV virus load(HBV DNA)\> 1×10'4copies/ml;
6. CNS or meningeal involvement;
7. 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;
8. Concomitant with other hematologic diseases(such as leukemia, hemophilia primary myelofibrosis) which investigator it unsuitable to be enrolled into this clinical trial;
9. Active and severe infectious diseases;
10. Major surgery within three weeks;
11. Any potential drug abuse, medical, psychological or social conditions which may disturb this investigation and assessment.
12. In any conditions which investigator considered ineligible for this study.
13. Known sensitivity or allergy to investigational Product.
70 Years
90 Years
ALL
No
Sponsors
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The First Affiliated Hospital with Nanjing Medical University
OTHER
Responsible Party
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WEI XU
Professor
Principal Investigators
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Wei Xu, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital)
Locations
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Tongji Medical College of HUST
Wuhan, Hubei, China
The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital)
Nanjing, Jiangsu, China
QiLu Hospital of Shandong University
Jinan, Shandong, China
Shandong Province Hospital
Jinan, Shandong, China
Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Sudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Jianfeng Zou
Role: primary
Luqun Wang, M.D., Ph.D.
Role: primary
Xin Wang, M.D., Ph.D.
Role: primary
Weili Zhao, M.D., Ph.D.
Role: primary
Ye Guo, M.D., Ph.D.
Role: primary
References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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JSPH-002
Identifier Type: -
Identifier Source: org_study_id
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