Status:
UNKNOWN
Trial of DA-EPOCH Regimen for NHL With HLH
Lead Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Conditions:
NHL With Hemophagocytic Lymphohistiocytosis
Eligibility:
All Genders
15-80 years
Phase:
PHASE2
Brief Summary
The major purpose of this clinical study is to assess clinical outcome of dose-adjusted EPOCH regimen for patients with non-Hodgkin's lymphoma(NHL)-associated hemophagocytic lymphohistiocytosis
Detailed Description
Lymphoma-associated hemophagocytic lymphohistiocytosis(LA-HLH) has a high fatality rate and the worst outcome. The major cause of LA-HLH is aggressive non-Hodgkin's lymphoma(NHL), especially T/NKT cel...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2019
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01818908
Start Date
June 1 2012
End Date
April 1 2019
Last Update
February 15 2019
Active Locations (4)
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1
ChangZhou No.2 People's Hospital
Changzhou, Jiangsu, China, 213011
2
HuaiAn First People's Hospital
HuaiAn, Jiangsu, China, 223300
3
JiangSu Province Hospital
Nanjing, Jiangsu, China, 210029
4
WuXi People's Hospital
Wuxi, Jiangsu, China, 214023