Trial of DA-EPOCH Regimen for NHL With HLH

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01818908
Recruitment Status : Unknown
Verified March 2013 by WEI XU, The First Affiliated Hospital with Nanjing Medical University.
Recruitment status was:  Recruiting
First Posted : March 27, 2013
Last Update Posted : March 27, 2013
Information provided by (Responsible Party):
WEI XU, The First Affiliated Hospital with Nanjing Medical University

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

Condition or disease Intervention/treatment Phase
NHL With Hemophagocytic Lymphohistiocytosis Drug: DA-EPOCH Phase 2

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 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 efficacy.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Study of Dose-adjusted EPOCH Regimen for Non-Hodgkin's Lymphoma With Hemophagocytic Lymphohistiocytosis
Study Start Date : June 2012
Estimated Primary Completion Date : October 2013
Estimated Study Completion Date : April 2014

Arm Intervention/treatment
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.

DA-EPOCH regimen
Other Names:
  • Infused agents
  • Etoposide
  • Doxorubicin
  • Vincristine
  • Cyclophosphamide
  • Prednisone
  • Rituximab(B-NHL)

Primary Outcome Measures :
  1. overall response rate [ Time Frame: one year ]
    overall response rate after treated by DA-EPOCH regimen

  2. Time to Response [ Time Frame: four weekd after treatment of DA-EPOCH ]
    To determine the median time to overall response

Secondary Outcome Measures :
  1. progression free survival [ Time Frame: one year ]
    progression free survival after treatment of DA-EPOCH regimen

  2. overall survival [ Time Frame: one year ]
    overall survival after treatment of DA-EPOCH regimen

  3. Number of Participants with Adverse Events [ Time Frame: up to 30 days after last dose of treatment ]
    Number of Participants with Adverse Events, and evaluated standard is according to common terminology criteria adverse events(CTCAE) version 4.0

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Ages Eligible for Study:   15 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Histologically confirmed non-Hodgkin's lymphoma;
  2. Patients whose clinical findings satisfy either of HLH 2004 standard or ASH2009 standard:

    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 diagnosis:
    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 trial;
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01818908

Contact: LEI FAN, M.D., Ph.D. +86 25 6813 6034

China, Jiangsu
ChangZhou No.2 People's Hospital Recruiting
ChangZhou, Jiangsu, China, 213011
Contact: Min Zhou, Dr.         
Principal Investigator: Min Zhou, M.D.         
HuaiAn First People's Hospital Recruiting
HuaiAn, Jiangsu, China, 223300
Contact: Liang Yu, Dr.         
Principal Investigator: Liang Yu, M.D., Ph.D.         
JiangSu Province Hospital Recruiting
NanJing, Jiangsu, China, 210029
Contact: LEI FAN, Dr.    86 25 6813 6034      
Principal Investigator: WEI XU, M.D., Ph.D.         
WuXi People's Hospital Recruiting
WuXi, Jiangsu, China, 214023
Contact: Yun Zhuang, M.D.         
Principal Investigator: YunFeng Shen, M.D., Ph.D.         
Sponsors and Collaborators
The First Affiliated Hospital with Nanjing Medical University
Principal Investigator: Wei Xu, M.D., Ph.D. The First Affiliated Hospital with Nanjing Medical University

Responsible Party: WEI XU, Professor, The First Affiliated Hospital with Nanjing Medical University Identifier: NCT01818908     History of Changes
Other Study ID Numbers: JSPH-HLH-001
First Posted: March 27, 2013    Key Record Dates
Last Update Posted: March 27, 2013
Last Verified: March 2013

Keywords provided by WEI XU, The First Affiliated Hospital with Nanjing Medical University:
non-Hodgkin's lymphoma
hemophagocytic lymphohistiocytosis

Additional relevant MeSH terms:
Lymphohistiocytosis, Hemophagocytic
Histiocytosis, Non-Langerhans-Cell
Lymphatic Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents, Phytogenic
Tubulin Modulators