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Clinical Study of Dose-adjusted EPOCH Regimen for Non-Hodgkin's Lymphoma With Hemophagocytic Lymphohistiocytosis

Phase 2
15 Years
80 Years
Open (Enrolling)
NHL With Hemophagocytic Lymphohistiocytosis

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Trial Information

Clinical Study of Dose-adjusted EPOCH Regimen for Non-Hodgkin's Lymphoma With Hemophagocytic Lymphohistiocytosis

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 cell lymphomas. Until now, there is no recommended therapeutic schedule for
this fatal disease. Dose-adjusted(DA) EPOCH (etoposide, prednisone, vincristine,
cyclophosphamide, and doxorubicin) shows effective activity in patients with aggressive
NHL. The investigators therefore developed DA-EPOCH regimen to treat non-Hodgkin's lymphoma
with hemophagocytic lymphohistiocytosis and assess its clinical outcome including safety and

Inclusion Criteria:

1. Histologically confirmed non-Hodgkin's lymphoma;

2. Patients whose clinical findings satisfy either of HLH 2004 standard or ASH2009

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.

ASH2009 Standard

1. .At least 3 of 4:

1. Fever

2. Splenomegaly

3. Cytopenias (minimum 2 cell lines reduced)

4. Hepatitis

2. . And at least 1 of 4:

1. Hemophagocytosis

2. ↑ Ferritin

3. ↑ sIL2Rα (age based)

4. Absent or very decreased NK function 4. Other results supportive of HLH

1. Hypertriglyceridemia

2. Hypofibrinogenemia

3. Hyponatremia

Exclusion Criteria:

1. Primary HLH.

2. HLH from rheumatic disorder (such as SLE, AOSD, antiphospholipid antibody syndrome)

3. Pregnancy (as determined by serum or urine test) or active breast feeding

4. Concomitant malignancy other than non-Hodgkin's lymphoma and need to treat;

5. Concomitant with other hematologic diseases(such as leukemia,hemophilia primary
myelofibrosis) which investigator it unsuitable to be enrolled into this clinical

6. Any potential drug abuse, medical, psychological or social conditions which may
disturb this investigation and assessment.

7. In any conditions which investigator considered ineligible for this study.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

overall response rate

Outcome Description:

overall response rate after treated by DA-EPOCH regimen

Outcome Time Frame:

one year

Safety Issue:


Principal Investigator

Wei Xu, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Jiangsu Province Hospital


China: Ministry of Health

Study ID:




Start Date:

June 2012

Completion Date:

April 2014

Related Keywords:

  • NHL With Hemophagocytic Lymphohistiocytosis
  • non-Hodgkin's lymphoma
  • hemophagocytic lymphohistiocytosis
  • rituximab
  • Lymphohistiocytosis, Hemophagocytic
  • Lymphoma, Non-Hodgkin