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

Recruiting now · Phase 1/Phase 2

Conditions studied: DLBCL, Untreated, MYC Gene Rearrangement

In brief

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.

Key facts

Study ID

NCT04432714

Run by

The First Affiliated Hospital with Nanjing Medical University

People needed

81

Starts

2020-06-09

Expected to finish

2026-12-31

Last updated by the study team

2020-06-16

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 1.5×109/L or platelet count less than 75×109/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.

Where it is running

• The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital) — Nanjing, Jiangsu, China (enrolling)

Full record on ClinicalTrials.gov

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