Lenalidomide in Combination With R-GemOx in First-line Treatment of Elderly Diffuse Large B Cell Lymphoma

STATUS

Recruiting
End date

Dec 31, 2024
participants needed

124
sponsor

The First Affiliated Hospital with Nanjing Medical University

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Updated on 19 February 2024

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lymphoma

lenalidomide

b-cell lymphoma

diffuse large b-cell lymphoma

gemox

hiv related lymphoma

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.

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.

Details

Condition	Diffuse Large B-Cell Lymphoma
Age	60-100 years
Treatment	Lenalidomide
Clinical Study Identifier	NCT04432402
Sponsor	The First Affiliated Hospital with Nanjing Medical University
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	The histopathologic diagnosis was DLBCL (except primary mediastinal large B cell lymphoma, primary central lymphoma, HIV related lymphoma)
	Age older than 70 years or older than 60 years with Eastern Cooperative Oncology Group(ECOG) performance status(PS) 2
	Expected survival 12 weeks
	At least a measurable or evaluable disease at the time of enrolment (diameter 1.5cm)
	Understand and voluntarily sign an informed consent form, able to adhere to the study visit schedule and other protocol requirements
	All patients must agree to take effective contraceptive measures during the trial measures
Exclusion Criteria
	Active hepatitis B or hepatitis C virus infection, as well as acquired, congenital immune deficiency diseases, including but not limited to HIV infected persons
	Patients known to have varicella or herpes zoster virus infection
	Previous exposure to any anti-tumor therapy
	Poor hepatic and/or renal function, unless these abnormalities were related to the lymphoma
	Poor bone-marrow reserve, defined as neutrophil count less than 1.5109/L or platelet count less than 75109/L, unless caused by bone marrow infiltration
	History of deep vein thrombosis (DVT) or pulmonary embolism (PE) within past 12 months
	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
	Central nervous system (CNS) or meningeal involvement
	Known sensitivity or allergy to investigational product
	Major surgery within three weeks
	Patients receiving organ transplantation
	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
	Presence of Grade III nervous toxicity within past two weeks
	Active and severe infectious diseases
	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
	Histologic transformation

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Lenalidomide in Combination With R-GemOx in First-line Treatment of Elderly Diffuse Large B Cell Lymphoma