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

Sponsor

The First Affiliated Hospital with Nanjing Medical University (Other)

Overall Status

Unknown status

CT.gov ID

NCT02767674

Collaborator

(none)

258

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Diffuse Large B Cell Lymphoma	Drug: Rituximab Drug: Gemcitabine Drug: Oxaliplatin Drug: Cyclophosphamide Drug: Epirubicin Injectable Product Drug: Vindesine Drug: Prednisone	Phase 3

Detailed 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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

258 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Phase III,Randomized Controlled Trial of R-GemOx Versus R-miniCHOP Regimen in First-line Treatment of Elderly Diffuse Large B Cell Lymphoma

Study Start Date :

May 1, 2016

Anticipated Primary Completion Date :

Dec 1, 2020

Anticipated Study Completion Date :

Dec 1, 2020

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: R-GemOx

Rituximab: 375 mg/m2 IV day0, Gemcitabine 1g/m2 IV day 1, oxaliplatin 100mg/m2 IV day1(every 14 days)

Drug: Rituximab

375 mg/m2 IVD day0

Drug: Gemcitabine

Gemcitabine 1 g/m2 IVD day 1

Drug: Oxaliplatin

Oxaliplatin 100 mg/m2 IVD day1

Active Comparator: R-miniCHOP

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)

Drug: Rituximab

375 mg/m2 IVD day0

Drug: Cyclophosphamide

Cyclophosphamide 400 mg/m2 IVD d1

Drug: Epirubicin Injectable Product

Epirubicin 35 mg/m2 IVD d1

Drug: Vindesine

Vindesine 2 mg IVP d1

Drug: Prednisone

Prednisone 40mg/m2 PO d1-5

Outcome Measures

Primary Outcome Measures

2-year overall survival rate [One year]
from the date of inclusion to date of death, irrespective of cause

Secondary Outcome Measures

2-year progression free survival rate [One year]
from date of inclusion to date of progression, relapse, or death from any causePFS：from date of inclusion to date of progression, relapse, or death from any cause
overall response rate [One year]
overall response rate after treated by R-GemOx or R-miniCHOP overall response rate after treated by R-GemOx or R-miniCHOP regimen

Eligibility Criteria

Criteria

Ages Eligible for Study:

70 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Histologically confirmed diffuse large B cell lymphoma（With exception of Primary mediastinal large B cell lymphoma、Primary central nervous system lymphoma、HIV-related lymphoma);
New-diagnosed and untreated;
Age older than 80 years or older than 70 years with ECOG PS ≥ 2;
Ann Arbor stage I to stage IV disease;
Understand and voluntarily sign an informed consent form, able to adhere to the study visit schedule and other protocol requirements.

Exclusion Criteria:

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;
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;
Presence of Grade III nervous toxicity with two weeks;
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
Positive HIV, syphilis,HCV, or HBV virus load(HBV DNA)> 1×10'4copies/ml;
CNS or meningeal involvement;
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;
Concomitant with other hematologic diseases(such as leukemia, hemophilia primary myelofibrosis) which investigator it unsuitable to be enrolled into this clinical trial;
Active and severe infectious diseases;
Major surgery within three weeks;
Any potential drug abuse, medical, psychological or social conditions which may disturb this investigation and assessment.
In any conditions which investigator considered ineligible for this study.
Known sensitivity or allergy to investigational Product.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tongji Medical College of HUST	Wuhan	Hubei	China	430030
2	The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital)	NanJing	Jiangsu	China	21002
3	QiLu Hospital of Shandong University	Jinan	Shandong	China	250012
4	Shandong Province Hospital	Jinan	Shandong	China	250021
5	Rui Jin Hospital Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai	China	200025
6	Sudan University Shanghai Cancer Center	Shanghai	Shanghai	China	200433