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Trial of R-GemOx Versus R-miniCHOP Regimen in First-line Treatment of Elderly Diffuse Large B Cell Lymphoma

N

Nanjing Medical University

Status and phase

Unknown
Phase 3

Conditions

Diffuse Large B Cell Lymphoma

Treatments

Drug: Gemcitabine
Drug: Oxaliplatin
Drug: Cyclophosphamide
Drug: Rituximab
Drug: Vindesine
Drug: Prednisone
Drug: Epirubicin Injectable Product

Study type

Interventional

Funder types

Other

Identifiers

NCT02767674
JSPH-002

Details and patient eligibility

About

The purpose of this study is to investigate efficacy and safety of R-GemOx Versus R-miniCHOP as first-line treatment of elderly patients with Diffuse large B cell lymphoma

Full description

Gemcitabine and Oxaliplatin(GemOx) shows effective activity in patients with relapsed diffuse large-cell lymphoma and other solid tumors. Our Previous study showed that two-weekly regimen of rituximab combined with GemOx regimen acheived comparable response rate to R-miniCHOP.The investigators therefore design this open-label,phase III and random trial to compared the safety and efficacy of R-Gemox versus R-miniCHOP as first-line treatment of elderly patients with diffuse large B cell lymphoma.

Primary Outcome Measures:

• 2-year overall survival rate

Secondary Outcome Measures:

  • 2-year progression free survival rate
  • overall response rate
  • safety and toxicity Enrollment:258 Study Start Date: June 2016 Primary Completion Date: June 2019

Enrollment

258 estimated patients

Sex

All

Ages

70 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Histologically confirmed diffuse large B cell lymphoma(With exception of Primary mediastinal large B cell lymphoma、Primary central nervous system lymphoma、HIV-related lymphoma);
  2. New-diagnosed and untreated;
  3. Age older than 80 years or older than 70 years with ECOG PS ≥ 2;
  4. Ann Arbor stage I to stage IV disease;
  5. 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 and/or renal function, defined as total bilirubin, ALT, AST, Cr more than two fold of upper normal level, unless these abnormalities were related to the lymphoma;
  2. Poor bone-marrow reserve, defined as neutrophil count less than 1.5×10⁹/L or platelet count less than 75×10⁹/L, unless caused by bone marrow infiltration;
  3. Presence of Grade III nervous toxicity with two weeks;
  4. New York Heart Association class III or IV cardiac failure; or Ejection fraction less than 50%;or history of following disease in past 6 months: acute coronary syndrome、acute heart failure、severe ventricular arrhythmia
  5. Positive HIV, syphilis,HCV, or HBV virus load(HBV DNA)> 1×10'4copies/ml;
  6. CNS or meningeal involvement;
  7. Concomitant malignancy other than aggressive B cell lymphoma and need to Treat, with the exception of non-melanoma skin tumours or stage 0 (in situ) cervical carcinoma,or history of cancer more than 5 years;
  8. Concomitant with other hematologic diseases(such as leukemia, hemophilia primary myelofibrosis) which investigator it unsuitable to be enrolled into this clinical trial;
  9. Active and severe infectious diseases;
  10. Major surgery within three weeks;
  11. Any potential drug abuse, medical, psychological or social conditions which may disturb this investigation and assessment.
  12. In any conditions which investigator considered ineligible for this study.
  13. Known sensitivity or allergy to investigational Product.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

258 participants in 2 patient groups

R-GemOx
Experimental group
Description:
Rituximab: 375 mg/m2 IV day0, Gemcitabine 1g/m2 IV day 1, oxaliplatin 100mg/m2 IV day1(every 14 days)
Treatment:
Drug: Oxaliplatin
Drug: Rituximab
Drug: Gemcitabine
R-miniCHOP
Active Comparator group
Description:
Rituximab, 375 mg/m2 IV d0 Cyclophosphamide 400 mg/m2 IV d1 Epirubicin 35 mg/m2 IV d1 vindesine 2 mg IVP d1 Prednisone 40mg/m2 PO d1-5(every 21 days a cycle)
Treatment:
Drug: Prednisone
Drug: Epirubicin Injectable Product
Drug: Rituximab
Drug: Cyclophosphamide
Drug: Vindesine

Trial contacts and locations

6

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Central trial contact

Huayuan Zhu, M.D., Ph.D.; Wei Xu, M.D., Ph.D.

Data sourced from clinicaltrials.gov

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