Actively Recruiting
Lenalidomide in Combination With R-DA-EPOCH in Patients With Untreated DLBCL With MYC Rearrangement
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2020-06-16
81
Participants Needed
1
Research Sites
342 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Lenalidomide in Combination With R-DA-EPOCH in Patients With Untreated DLBCL With MYC Rearrangement
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed DLBCL with MYC rearrangement according to WHO 2016 criteria, excluding PMBCL, PCNSL, HIV-associated lymphoma
- ECOG performance status of 0 to 2
- Age between 18 and 60 years old
- Expected survival of at least 12 weeks
- Measurable or evaluable disease with diameter of at least 1.5 cm at enrollment
- Ability to understand and voluntarily sign informed consent and adhere to study visits and protocol requirements
You will not qualify if you...
- Pregnant or lactating women, or those planning pregnancy within 12 months without effective contraception
- Active hepatitis B or C infection, or acquired/congenital immune deficiency diseases including HIV
- Prior exposure to any anti-tumor therapy
- Poor liver or kidney function (bilirubin, ALT, AST, creatinine more than twice normal; creatinine clearance less than 50 mL/min) unless due to lymphoma
- History of deep vein thrombosis or pulmonary embolism within past 12 months
- Poor bone marrow function (neutrophil count less than 1.5 x10^9/L or platelet count less than 75 x10^9/L) unless from bone marrow infiltration
- Severe heart failure (NYHA class III or IV), ejection fraction less than 50%, or recent acute coronary syndrome, heart failure, or severe arrhythmia within 6 months
- Central nervous system or meningeal involvement
- Known allergy or sensitivity to study treatments
- Major surgery within past three weeks
- Organ transplant recipients
- Secondary tumors except certain cured skin, bladder, cervical, gastrointestinal, or breast cancers
- Grade III nervous system toxicity within past two weeks
- Active severe infections
- Drug abuse or medical, psychological, or social conditions interfering with study
- Any condition deemed ineligible by investigator
- Histological transformation of lymphoma
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital)
Nanjing, Jiangsu, China, 210029
Actively Recruiting
Research Team
L
Li Wang, M.D., Ph.D
CONTACT
W
Wei Xu, M.D., Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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