DLBCL, MYC Gene Rearrangement, Untreated
Conditions
Keywords
DLBCL, MYC Gene rearrangement, Lenalidomide, R-DA EPOCH
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.
Interventions
DRUGLenalidomide
Lenalidomide 10mg/d#15mg/d#20mg/d#25mg/d d1\ d10# 21days a cycle
DRUGRituximab
Rituximab 375 mg/m2，IV, d0
DRUGEtoposide
Etoposide 50 mg/m2/day CI24h d1-d4
DRUGDoxorubicin
Doxorubicin 10 mg/m2/day CI24h d1-d4
DRUGVincristine
Vincristine 0.4mg/m2/day CI24h d1-d4
DRUGCyclophosphamide
Cyclophosphamide 750 mg/m2/day IV d5
DRUGPrednisone
Prednisone 60 mg/m2/bid oral or IV d1-d5
Sponsors
The First Affiliated Hospital with Nanjing Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| maximum tolerated dose and dose limited toxicity | 21 days after first cycle of R2-DA-EPOCH regimen (each cycle is 21 days) |
| Overall response rate | 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progressive free survival | 2 years | from date of inclusion to date of progression, relapse, or death from any cause |
| Overall survival | 2 years | from the date of inclusion to date of death, irrespective of cause |
Countries
China
Contacts
Primary ContactLi Wang, M.D., Ph.D
Backup ContactWei Xu, M.D., Ph.D
Outcome results
None listed