Lenalidomide in Combination With R-DA-EPOCH in Patients With Untreated DLBCL With MYC Rearrangement

STATUS

Recruiting
End date

Dec 31, 2026
participants needed

81
sponsor

The First Affiliated Hospital with Nanjing Medical University

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Updated on 25 January 2021

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cyclophosphamide

rituximab

vincristine

prednisone

etoposide

doxorubicin

lenalidomide

da-epoch

Summary

The prognosis of DLBCL with MYC rearrangement is dismal. Previous study showed that lenalidomide in combination with R-CHOP showed promising therapeutic activity and that R-DA EPOCH was superior compared to R-CHOP regimen in this cohort of patients. The investigators therefore design this phase I/II study to investigate the safety and efficacy of lenalidomide in combination with R-DA EPOCH in patients with untreated MYC-rearranged DLBCL.

Details

Condition	Diffuse Large B-Cell Lymphoma, Untreated, MYC Gene Rearrangement, diffuse large cell lymphoma, diffuse large b cell lymphoma
Treatment	Rituximab, cyclophosphamide, etoposide, prednisone, vincristine, doxorubicin, Lenalidomide
Clinical Study Identifier	NCT04432714
Sponsor	The First Affiliated Hospital with Nanjing Medical University
Last Modified on	25 January 2021

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Histologically confirmed DLBCL with MYC rearrangement according to WHO 2016 criteria, excluding PMBCL, PCNSL, HIV-associated lymphoma
	ECOG PS 0-2
	Age 18-60 years old
	Expected survival 12 weeks
	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
Exclusion Criteria
	Women who are pregnant or lactating. Patients have breeding intent in 12 months or cannot take effective contraceptive measures during the trial measures
	Active hepatitis B or hepatitis C virus infection, as well as acquired, congenital immune deficiency diseases, including but not limited to HIV infected persons
	Previous exposure to any anti-tumor therapy
	Poor hepatic and/or renal function, defined as total bilirubin, ALT, AST, Cr more than two fold of upper normal level,Ccr# 50 mL/min unless these abnormalities were related to the lymphoma
	History of DVT or PE within past 12 months
	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
	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
	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 whichmay disturb this investigation and assessment
	In any conditions which investigator considered ineligible for this study
	Patients with histological transformation

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Lenalidomide in Combination With R-DA-EPOCH in Patients With Untreated DLBCL With MYC Rearrangement