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

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)

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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