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

Primary Purpose

Diffuse Large B-cell Lymphoma

Status

Unknown status

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

R-GemOx

About this trial

This is an interventional treatment trial for Diffuse Large B-cell Lymphoma focused on measuring Rituximab, Gemcitabine, Oxaliplatin, Diffuse large B-cell lymphoma

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Rituximab+Gemcitabine+oxaliplatin (R-GemOx)

Arm Description

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

Outcomes

Primary Outcome Measures

overall response rate

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

Secondary Outcome Measures

progression free survival

from date of inclusion to date of progression, relapse from response, or death from any cause or last follow-up.

overall survival

from the date of inclusion to date of death, irrespective of cause or last follow-up.

The incidence and severity of adverse events

All the treatment related adverse events was evaluated according to common terminology criteria adverse events(CTCAE) version 4.0

Full Information

NCT ID

NCT01670370

First Posted

August 7, 2012

Last Updated

February 13, 2019

Sponsor

The First Affiliated Hospital with Nanjing Medical University

1. Study Identification

Unique Protocol Identification Number

NCT01670370

Brief Title

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

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Unknown status

Study Start Date

August 2012 (undefined)

Primary Completion Date

December 2015 (Actual)

Study Completion Date

December 2019 (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 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

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

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Rituximab+Gemcitabine+oxaliplatin (R-GemOx)

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

R-GemOx

Other Intervention Name(s)

Rituximab, Gemcitabine, Oxaliplatin

Intervention Description

Rituximab Gemcitabine Oxaliplatin

Primary Outcome Measure Information:

Title

overall response rate

Description

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

Time Frame

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

Secondary Outcome Measure Information:

Title

progression free survival

Description

from date of inclusion to date of progression, relapse from response, or death from any cause or last follow-up.

Time Frame

Two-year

Title

overall survival

Description

from the date of inclusion to date of death, irrespective of cause or last follow-up.

Time Frame

Two-year

Title

The incidence and severity of adverse events

Description

All the treatment related adverse events was evaluated according to common terminology criteria adverse events(CTCAE) version 4.0

Time Frame

Up to 30 days following the last dose of study drug

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

WEI XU, M.D., Ph.D.

Organizational Affiliation

The First Affiliated Hospital with Nanjing Medical University

Official's Role

Principal Investigator

12. IPD Sharing Statement

Citations:

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

background

PubMed Identifier

21123151

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.

Results Reference

background

PubMed Identifier

29752199

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.

Results Reference

derived

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

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