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

February 13, 2019 updated by: WEI XU, The First Affiliated Hospital with Nanjing Medical University

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).

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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)
Drug: R-GemOx
Rituximab Gemcitabine Oxaliplatin
Other Names:
  • Rituximab
  • Gemcitabine
  • Oxaliplatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall response rate
Time Frame: 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.
at the end of 3 cycles and 6 cycles of R-GemOx regimen(each cycle is 14 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
progression free survival
Time Frame: Two-year
from date of inclusion to date of progression, relapse from response, or death from any cause or last follow-up.
Two-year
overall survival
Time Frame: Two-year
from the date of inclusion to date of death, irrespective of cause or last follow-up.
Two-year
The incidence and severity of adverse events
Time Frame: 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
Up to 30 days following the last dose of study drug

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Investigators

  • Principal Investigator: Wei Xu, M.D., Ph.D., The First Affiliated Hospital with Nanjing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

December 1, 2015

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

August 7, 2012

First Submitted That Met QC Criteria

August 19, 2012

First Posted (Estimate)

August 22, 2012

Study Record Updates

Last Update Posted (Actual)

February 15, 2019

Last Update Submitted That Met QC Criteria

February 13, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JSPH-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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