Clinical trial NCT01670370: Trial of R-GemOx Regimen in Previously Untreated Elderly Patients With DLBCL.
Official title: A Prospective, Single-arm, Open-label, Phase 2 Study to Evaluate Efficacy and Safety of R-GemOx Regimen as First-line Treatment in Elderly Patients With Diffuse Large B-cell Lymphoma (DLBCL).
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Diffuse Large B-cell Lymphoma
Keywords: Rituximab
Gemcitabine
Oxaliplatin
Diffuse large B-cell lymphoma
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2012-08-22
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed description: Previous studies showed that the combination of rituximab, gemcitabine and oxaliplatin (R-GemOx) achieved high efficacy with a low toxicity profile in relapsed and refractory DLBCL. This regimen might be considered a putative treatment option for elderly patients. To our knowledge, the efficacy and safety of R-GemOx when given as first-line therapy in elderly patients with DLBCL remains unknown. The investigators therefore developed a two-weekly regimen of rituximab combined with GemOx regimen as first line treatment in elderly DLBCL and investigate its efficacy and safety.

Primary Outcome Measures:

* overall response rate

Secondary Outcome Measures:

* progression free survival
* overall survival
* safety and toxicity

Enrollment: 60 Study Start Date: August 2012 Primary Completion Date: Dec 2015

Eligibility criteria: Inclusion criteria:

1. 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);
2. New-diagnosed and untreated;
3. Age older than 70 years or older than 60 years with ECOG PS ≥2;
4. Understand and voluntarily sign an informed consent form, able to adhere to the study visit schedule and other protocol requirements.

Exclusion Criteria:

1. Poor hepatic or renal function, defined as total serum bilirubin, transaminases or creatinine over two times of the upper limit of normal concentration;
2. Poor cardiac function greater than Grade II according to New York Heart Association Functional Classification;
3. Presence of Grade III nervous toxicity over two weeks;
4. Hepatitis B virus (HBV) load (HBV DNA) more than 1×105 copies/ml;
5. Concomitant malignancy other than DLBCL requiring treatment;
6. Concomitant with other hematologic diseases (such as leukemia, hemophilia, primary myelofibrosis) which is unsuitable to be enrolled into this clinical trial;
7. Contraindication to any drug in this regimen;
8. Active and severe infectious diseases, such as severe pheumonia or septicaemia;
9. Major surgery within three weeks;
10. Any medical, psychological or social conditions which might interfere with the investigators' assessment
11. In any conditions which investigator considered ineligible for this study.

Primary outcomes:
measure: overall response rate
timeFrame: at the end of 3 cycles and 6 cycles of R-GemOx regimen(each cycle is 14 days)
Secondary outcomes:
measure: progression free survival
timeFrame: Two-year
measure: overall survival
timeFrame: Two-year
measure: The incidence and severity of adverse events
timeFrame: Up to 30 days following the last dose of study drug
Other outcomes:
Locations:
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: WEI XU, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
citation: 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.