Trial of R-GemOx Versus R-miniCHOP Regimen in First-line Treatment of Elderly Diffuse Large B Cell Lymphoma

NCT02767674 | Unknown Phase 3 DMC

• 1 other identifier: JSPH-002
• Study Type: interventional
• Target: 258
• Locations: 1 country
• Sites: 6

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

Conditions

Diffuse Large B Cell Lymphoma

Keywords

R-Gemox; R-miniCHOP; elderly patients with diffuse large B cell lymphoma

Outcome Measures

Primary Outcomes (1)

• 2-year overall survival rate

  from the date of inclusion to date of death, irrespective of cause

  One year

Secondary Outcomes (2)

• 2-year progression free survival rate

  One year

• overall response rate

  One year

Study Arms (2)

R-GemOx

EXPERIMENTAL

Rituximab: 375 mg/m2 IV day0, Gemcitabine 1g/m2 IV day 1, oxaliplatin 100mg/m2 IV day1(every 14 days)

Drug: Rituximab; Drug: Gemcitabine; Drug: Oxaliplatin

R-miniCHOP

ACTIVE COMPARATOR

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)

Drug: Rituximab; Drug: Cyclophosphamide; Drug: Epirubicin Injectable Product; Drug: Vindesine; Drug: Prednisone

Interventions

Rituximab DRUG

375 mg/m2 IVD day0

R-GemOx; R-miniCHOP

Gemcitabine DRUG

Gemcitabine 1 g/m2 IVD day 1

R-GemOx

Oxaliplatin DRUG

Oxaliplatin 100 mg/m2 IVD day1

R-GemOx

Cyclophosphamide DRUG

Cyclophosphamide 400 mg/m2 IVD d1

R-miniCHOP

Epirubicin Injectable Product DRUG

Epirubicin 35 mg/m2 IVD d1

R-miniCHOP

Vindesine DRUG

Vindesine 2 mg IVP d1

R-miniCHOP

Prednisone DRUG

Prednisone 40mg/m2 PO d1-5

R-miniCHOP

Eligibility Criteria

• Age: 70 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (6)

Tongji Medical College of HUST

Wuhan, Hubei, 430030, China

RECRUITING

The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital)

Nanjing, Jiangsu, 21002, China

RECRUITING

QiLu Hospital of Shandong University

Jinan, Shandong, 250012, China

RECRUITING

Shandong Province Hospital

Jinan, Shandong, 250021, China

RECRUITING

Rui Jin Hospital Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

Sudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

Related Publications (6)

• 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.

  PMID: 11807147 RESULT

• 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.

  PMID: 17785567 RESULT

• 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.

  PMID: 21482186 RESULT

• 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.

  PMID: 18005385 RESULT

• 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.

  PMID: 21940215 RESULT

• 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.

  PMID: 17400912 RESULT

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

Rituximab; Gemcitabine; Oxaliplatin; Cyclophosphamide; Vindesine; Prednisone

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Organic Chemicals; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phosphoramides; Organophosphorus Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Wei Xu, M.D., Ph.D.

  The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huayuan Zhu, M.D., Ph.D.

CONTACT

+86 68136034; huayuan.zhu@hotmail.com

Wei Xu, M.D., Ph.D.

CONTACT

+86 68136034; xuwei10000@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 7, 2016
• First Posted: May 10, 2016
• Study Start: May 1, 2016
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: January 3, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will share

Locations

CN (6)