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

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ClinicalTrials.gov Identifier: NCT01670370
Recruitment Status : Active, not recruiting
First Posted : August 22, 2012
Last Update Posted : April 11, 2018
Sponsor:
Information provided by (Responsible Party):
WEI XU, 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

Condition or disease Intervention/treatment Phase
Diffuse Large B-cell Lymphoma Drug: R-GemOx Phase 2

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  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : August 2012
Actual Primary Completion Date : December 2015
Estimated Study Completion Date : December 2018


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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. overall survival [ Time Frame: Two-year ]
    from the date of inclusion to date of death, irrespective of cause or last follow-up.

  3. 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



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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01670370


Sponsors and Collaborators
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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: WEI XU, Professor, The First Affiliated Hospital with Nanjing Medical University
ClinicalTrials.gov Identifier: NCT01670370     History of Changes
Other Study ID Numbers: JSPH-001
First Posted: August 22, 2012    Key Record Dates
Last Update Posted: April 11, 2018
Last Verified: April 2018

Keywords provided by WEI XU, The First Affiliated Hospital with Nanjing Medical University:
Rituximab
Gemcitabine
Oxaliplatin
Diffuse large B-cell lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Gemcitabine
Oxaliplatin
Rituximab
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents