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

NCT ID: NCT01670370

Last Updated: 2019-02-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2019-12-31

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

Conditions

Diffuse Large B-cell Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rituximab+Gemcitabine+oxaliplatin (R-GemOx)

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

Group Type: EXPERIMENTAL

R-GemOx

Intervention Type: DRUG

Rituximab Gemcitabine Oxaliplatin

Interventions

R-GemOx

Rituximab Gemcitabine Oxaliplatin

Intervention Type: DRUG

Other Intervention Names

Rituximab; Gemcitabine; Oxaliplatin

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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

WEI XU

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital with Nanjing Medical University

References

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.

Reference Type: BACKGROUND

PMID: 18005385 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21123151 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29752199 (View on PubMed)

Other Identifiers

JSPH-001

Identifier Type: -

Identifier Source: org_study_id