Trial of R-GemOx Regimen in Previously Untreated Elderly Patients With DLBCL.

NCT01670370 | Unknown Phase 2 DMC

• 1 other identifier: JSPH-001
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to investigate efficacy and safety of GemOx(Gemcitabine and Oxaliplatin) combination with rituximab(R) as first-line treatment of elderly patients with DLBCL

Conditions

Diffuse Large B-cell Lymphoma

Keywords

Rituximab; Gemcitabine; Oxaliplatin; Diffuse large B-cell lymphoma

Outcome Measures

Primary Outcomes (1)

• overall response rate

  overall response rate after 3 cycles and at the end of R-GemOx regimen.

  at the end of 3 cycles and 6 cycles of R-GemOx regimen(each cycle is 14 days)

Secondary Outcomes (3)

• progression free survival

  Two-year

• overall survival

  Two-year

• The incidence and severity of adverse events

  Up to 30 days following the last dose of study drug

Study Arms (1)

Rituximab+Gemcitabine+oxaliplatin (R-GemOx)

EXPERIMENTAL

Rituximab: 375 mg/m2 IV day1, Gemcitabine 1g/m2 IV day 2, oxaliplatin 100mg/m2 IV day2(every 14 days)

Drug: R-GemOx

Interventions

R-GemOx DRUG

Rituximab Gemcitabine Oxaliplatin

Also known as: Rituximab, Gemcitabine, Oxaliplatin

Rituximab+Gemcitabine+oxaliplatin (R-GemOx)

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed CD20-positive DLBCL (The germinal center B-cell like (GCB) / non-GCB subtype was determined by immunohistochemistry in paraffin-embedded tissue using CD10, BCL6 and MUM1 protein markers based on Hans's algorithm);
• New-diagnosed and untreated;
• Age older than 70 years or older than 60 years with ECOG PS ≥2;
• 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 or renal function, defined as total serum bilirubin, transaminases or creatinine over two times of the upper limit of normal concentration;
• Poor cardiac function greater than Grade II according to New York Heart Association Functional Classification;
• Presence of Grade III nervous toxicity over two weeks;
• Hepatitis B virus (HBV) load (HBV DNA) more than 1×105 copies/ml;
• Concomitant malignancy other than DLBCL requiring treatment;
• Concomitant with other hematologic diseases (such as leukemia, hemophilia, primary myelofibrosis) which is unsuitable to be enrolled into this clinical trial;
• Contraindication to any drug in this regimen;
• Active and severe infectious diseases, such as severe pheumonia or septicaemia;
• Major surgery within three weeks;
• Any medical, psychological or social conditions which might interfere with the investigators' assessment
• In any conditions which investigator considered ineligible for this study.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Related Publications (3)

• 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 BACKGROUND

• Meriggi F, Zaniboni A. Gemox: a widely useful therapy against solid tumors-review and personal experience. J Chemother. 2010 Oct;22(5):298-303. doi: 10.1179/joc.2010.22.5.298.

  PMID: 21123151 BACKGROUND

• Shen QD, Zhu HY, Wang L, Fan L, Liang JH, Cao L, Wu W, Xia Y, Li JY, Xu W. Gemcitabine-oxaliplatin plus rituximab (R-GemOx) as first-line treatment in elderly patients with diffuse large B-cell lymphoma: a single-arm, open-label, phase 2 trial. Lancet Haematol. 2018 Jun;5(6):e261-e269. doi: 10.1016/S2352-3026(18)30054-1. Epub 2018 May 8.

  PMID: 29752199 DERIVED

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

Rituximab; Gemcitabine; Oxaliplatin

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

Study Officials

• WEI XU, M.D., Ph.D.

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 7, 2012
• First Posted: August 22, 2012
• Study Start: August 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2019
• Last Updated: February 15, 2019

Record last verified: 2019-02