NCT04432714 Lenalidomide in Combination With R-DA-EPOCH in Patients With Untreated DLBCL With MYC Rearrangement
| NCT ID | NCT04432714 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | The First Affiliated Hospital with Nanjing Medical University |
| Condition | DLBCL |
| Study Type | INTERVENTIONAL |
| Enrollment | 81 participants |
| Start Date | 2020-06-09 |
| Primary Completion | 2024-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 81 participants in total. It began in 2020-06-09 with a primary completion date of 2024-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility Criteria
Inclusion Criteria: 1. Histologically confirmed DLBCL with MYC rearrangement according to WHO 2016 criteria, excluding PMBCL, PCNSL, HIV-associated lymphoma. 2. ECOG PS 0-2 3. Age 18-60 years old 4. Expected survival ≥ 12 weeks 5. A measurable or evaluable disease at the time of enrolment (diameter ≥1.5cm) 6. Understand and voluntarily sign an informed consent form, able to adhere to the study visit schedule and other protocol requirements. Exclusion Criteria: 1. Women who are pregnant or lactating. Patients have breeding intent in 12 months or cannot take effective contraceptive measures during the trial measures 2. Active hepatitis B or hepatitis C virus infection, as well as acquired, congenital immune deficiency diseases, including but not limited to HIV infected persons 3. Previous exposure to any anti-tumor therapy 4. 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 5. History of DVT or PE within past 12 months 6. 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 7. 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 8. CNS or meningeal involvement 9. Known sensitivity or allergy to investigational product 10. Major surgery within three weeks 11. Patients receiving organ transplantation 12. 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 13. Presence of Grade III nervous toxicity within past two weeks 14. Active and severe infectious diseases 15. Any potential drug abuse, medical, psychological or social conditions whichmay disturb this investigation and assessment 16. In any conditions which investigator considered ineligible for this study 17. Patients with histological transformation.
Contact & Investigator
Wei Xu, M.D., Ph.D
PRINCIPAL INVESTIGATOR
The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital)
Frequently Asked Questions
Who can join the NCT04432714 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying DLBCL. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04432714 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04432714 currently recruiting?
Yes, NCT04432714 is actively recruiting participants. Contact the research team at lilyw7878@163.com for enrollment information.
Where is the NCT04432714 trial being conducted?
This trial is being conducted at Nanjing, China.
Who is sponsoring the NCT04432714 clinical trial?
NCT04432714 is sponsored by The First Affiliated Hospital with Nanjing Medical University. The principal investigator is Wei Xu, M.D., Ph.D at The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital). The trial plans to enroll 81 participants.