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

  • End date
    Dec 31, 2026
  • participants needed
  • sponsor
    The First Affiliated Hospital with Nanjing Medical University
Updated on 25 January 2021


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.

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 IdentifierNCT04432714
SponsorThe First Affiliated Hospital with Nanjing Medical University
Last Modified on25 January 2021


Yes No Not Sure

Inclusion Criteria

Histologically confirmed DLBCL with MYC rearrangement according to WHO 2016 criteria, excluding PMBCL, PCNSL, HIV-associated lymphoma
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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