Status:
RECRUITING
Lenalidomide in Combination With R-DA-EPOCH in Patients With Untreated DLBCL With MYC Rearrangement
Lead Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Conditions:
DLBCL
Untreated
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
PHASE2
Brief 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 compa...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT04432714
Start Date
June 9 2020
End Date
December 31 2026
Last Update
June 16 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital)
Nanjing, Jiangsu, China, 210029