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

Phase 2

• Conditions: Diffuse Large B-cell Lymphoma
• Interventions: Drug: R-GemOx

• Registration Number: NCT01670370
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

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

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-08-07
• Study First Submitted QC: 2012-08-19
• Study First Posted: 2012-08-22
• Primary Completion: 2015-12
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-13
• Last Update Posted: 2019-02-15
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Rituximab+Gemcitabine+oxaliplatin (R-GemOx)	R-GemOx	Rituximab: 375 mg/m2 IV day1, Gemcitabine 1g/m2 IV day 2, oxaliplatin 100mg/m2 IV day2(every 14 days)

Primary Outcome Measures

Name	Time	Method
overall response rate	at the end of 3 cycles and 6 cycles of R-GemOx regimen(each cycle is 14 days)	overall response rate after 3 cycles and at the end of R-GemOx regimen.

Secondary Outcome Measures

Name	Time	Method
progression free survival	Two-year	from date of inclusion to date of progression, relapse from response, or death from any cause or last follow-up.
overall survival	Two-year	from the date of inclusion to date of death, irrespective of cause or last follow-up.
The incidence and severity of adverse events	Up to 30 days following the last dose of study drug	All the treatment related adverse events was evaluated according to common terminology criteria adverse events(CTCAE) version 4.0