Diffuse Large B Cell Lymphoma
Conditions
Keywords
R-Gemox, Lenalidomide
Brief summary
The purpose of this study is to investigate efficacy and safety of Lenalidomide in combination with R-GemOx as first-line treatment of elderly patients with Diffuse large B cell lymphoma.
Detailed description
Gemcitabine and Oxaliplatin(GemOx) shows effective activity in patients with relapsed diffuse large-cell lymphoma and other solid tumors. The purpose of this study is to investigate efficacy and safety of Lenalidomide in combination with R-GemOx as first-line treatment of elderly patients with Diffuse large B cell lymphoma.
Interventions
DRUGLenalidomide
Lenalidomide: 10mg、15mg、20mg、25mg qd PO day 1-7, Rituximab: 375 mg/m2 IV day0, Gemcitabine :1g/m2 IV day 1, oxaliplatin 100mg/m2 IV day1 (every 14 days as a cycle)
Sponsors
The First Affiliated Hospital with Nanjing Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. The histopathologic diagnosis was DLBCL (except primary mediastinal large B cell lymphoma, primary central lymphoma, HIV related lymphoma). 2. Age older than 70 years or older than 60 years with Eastern Cooperative Oncology Group(ECOG) performance status(PS) ≥ 2; 3. Expected survival ≥ 12 weeks; 4. At least a measurable or evaluable disease at the time of enrolment (diameter ≥1.5cm); 5. Understand and voluntarily sign an informed consent form, able to adhere to the study visit schedule and other protocol requirements; 6. All patients must agree to take effective contraceptive measures during the trial measures
Exclusion criteria
1. Active hepatitis B or hepatitis C virus infection, as well as acquired, congenital immune deficiency diseases, including but not limited to HIV infected persons 2. Patients known to have varicella or herpes zoster virus infection 3. Previous exposure to any anti-tumor therapy 4. Poor hepatic and/or renal function, unless these abnormalities were related to the lymphoma 5. 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 6. History of deep vein thrombosis (DVT) or pulmonary embolism (PE) within past 12 months 7. 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 8. Central nervous system (CNS) or meningeal involvement 9. Known sensitivity or allergy to investigational product 10. Major surgery within three weeks 11. Patients receiving organ transplantation 12. Patients with secondary tumour, excluding cured (5 years without relapse) in situ Non-melanoma skin cancer. superficial bladder cancer, in situ cervical cancer, Gastrointestinal intramucous carcinoma and breast cancer 13. Presence of Grade III nervous toxicity within past two weeks 14. Active and severe infectious diseases 15. Any potential drug abuse, medical, psychological or social conditions which may disturb this investigation and assessment 16. In any conditions which investigator considered ineligible for this study. 17. Histologic transformation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum tolerated dose | at the end of the first cycle of R2-GemOx (each cycle is 14 days) | Maximum tolerated dose |
| Dose limiting toxicity | 28 days | Dose limiting toxicity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| progression-free survival | 2 years | progression-free survival |
| overall survival | 2 years | overall survival |
Countries
China
Contacts
Primary ContactLi Wang, M.D
Backup ContactWei Xu, M.D., Ph.D
Outcome results
None listed