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

Diffuse Large B-cell Lymphoma Clinical Trial

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).

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01670370
• Other study ID #: JSPH-001
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: August 2012
• Est. completion date: December 2019

Study information

• Verified date: February 2019
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: December 2019
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diffuse Large B-cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

Intervention

Drug:
• R-GemOx
Rituximab Gemcitabine Oxaliplatin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University

References & Publications (2)

López A, Gutiérrez A, Palacios A, Blancas I, Navarrete M, Morey M, Perelló A, Alarcón J, Martínez J, Rodríguez 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. Epub 2007 Nov 20. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	progression free survival	from date of inclusion to date of progression, relapse from response, or death from any cause or last follow-up.	Two-year
Secondary	overall survival	from the date of inclusion to date of death, irrespective of cause or last follow-up.	Two-year
Secondary	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	Up to 30 days following the last dose of study drug