Trial of DA-EPOCH Regimen for NHL With HLH
NHL With Hemophagocytic Lymphohistiocytosis
About this trial
This is an interventional treatment trial for NHL With Hemophagocytic Lymphohistiocytosis focused on measuring non-Hodgkin's lymphoma, hemophagocytic lymphohistiocytosis, DA-EPOCH, rituximab
Eligibility Criteria
Inclusion Criteria:
1 .Histologically confirmed non-Hodgkin's lymphoma; 2. Patients whose clinical findings satisfy either of HLH 2004 standard: 3. newly-diagnosed and untreated; 4. understand and voluntarily sign an informed consent form, able to adhere to the study visit schedule and other protocol requirements.
HLH2004 standard at least 5 criteria out of the following: Fever ≥ 38.5 ℃ for ≥ 7 days; hepatosplenomegaly; Cytopenias affecting ≥ 2 of 3 lineages in PB Hb < 9 g/L Platelet < 100 x 109 /L ANC < 1.0 x 109 /L; Hypertriglyceridemia and/or hypofibrinogenemia (fasting triglycerides ≥ 265 mg/dL, fibrinogen ≤ 1.5 g/L); Hemophagocytosis in BM or spleen or LN; Low or absent NK-cell activity ( according to local laboratory reference); Serum-ferritin ≥ 500 mcg/L ; Soluble CD25(sIL-2 receptor) ≥ 2,400 U/ml ; 3.New-diagnosed and untreated; 4.Understand and voluntarily sign an informed consent form, able to adhere to the study visit schedule and other protocol requirements.
Exclusion criteria
- primary HLH;
- HLH from rheumatic disorder (such as systemic Lupus Erythematosus, adult onset still disease, antiphospholipid antibody syndrome);
- pregnancy (as determined by serum or urine test) or active breast feeding;
- concomitant malignancy other than NHL and need to treat;
- concomitant with other hematologic diseases (such as leukemia, hemophilia primary myelofibrosis) which investigators considered it unsuitable to be enrolled into this clinical trial;
- any potential drug abuse, medical, psychological or social conditions which may disturb this investigation and assessment;
- in any conditions which investigator considered ineligible for this study
Sites / Locations
- ChangZhou No.2 People's Hospital
- HuaiAn First People's Hospital
- JiangSu Province Hospital
- WuXi People's Hospital
Arms of the Study
Arm 1
Experimental
DA-EPOCH
Infused agents: Etoposide 50 mg/m2/day CI24h d1-d4; Doxorubicin 10 mg/m2/day CI24h d1-d4; Vincristine 0.4mg/m2/day CI24h d1-d4; Bolus agents: Rituximab(B-NHL) 375 mg/m2/day IV d0; Cyclophosphamide 750 mg/m2/day IV d5 ; Prednisone 60 mg/m2/bid oral or IV d1-d5; The details of dose adjustment are described in ref 1. If enrolled patient was histologically confirmed CD20+ B cell lymphoma, standard dose of rituximab will be recommend to combined with DA-EPOCH regimen.