Lenalidomide in Combination With R-GemOx in First-line Treatment of Elderly Diffuse Large B Cell Lymphoma
NCT ID: NCT04432402
Last Updated: 2020-06-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
124 participants
INTERVENTIONAL
2020-06-14
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Lenalidomide in Combination With R-GemOx
Lenalidomide 10mg、15mg、20mg、25mg qd PO d1-7 Rituximab 375mg/m2 ivd d0 Gemcitabine 1g/m2 ivd d1 Oxaliplatin 100mg/m2 ivd d1 every14 days as a cycle
Lenalidomide
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)
Interventions
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Lenalidomide
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)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
60 Years
ALL
No
Sponsors
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The First Affiliated Hospital with Nanjing Medical University
OTHER
Responsible Party
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WEI XU
Professor
Principal Investigators
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Wei Xu, M.D., Ph.D
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital with Nanjing Medical University
Locations
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The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital)
Nanjing, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2019-SR-443
Identifier Type: -
Identifier Source: org_study_id
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