Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 6 of 14 for:    mg/m2 | "familial hemophagocytic lymphohistiocytosis"

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.
ClinicalTrials.gov Identifier: NCT01818908
Recruitment Status : Active, not recruiting
First Posted : March 27, 2013
Last Update Posted : February 15, 2019
Sponsor:
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, which also contains the critical drugs for HLH of HLH-94/04. 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Single-arm, Open-label, Phase 2 Study to Evaluate Efficacy and Safety of DA-EPOCH Regimen for Non-Hodgkin's Lymphoma With Hemophagocytic Lymphohistiocytosis
Study Start Date : June 2012
Actual Primary Completion Date : October 2018
Estimated Study Completion Date : April 2019


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.

Drug: DA-EPOCH
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


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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

  1. primary HLH;
  2. HLH from rheumatic disorder (such as systemic Lupus Erythematosus, adult onset still disease, antiphospholipid antibody syndrome);
  3. pregnancy (as determined by serum or urine test) or active breast feeding;
  4. concomitant malignancy other than NHL and need to treat;
  5. concomitant with other hematologic diseases (such as leukemia, hemophilia primary myelofibrosis) which investigators considered 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 ClinicalTrials.gov identifier (NCT number): NCT01818908


Locations
Layout table for location information
China, Jiangsu
ChangZhou No.2 People's Hospital
ChangZhou, Jiangsu, China, 213011
HuaiAn First People's Hospital
HuaiAn, Jiangsu, China, 223300
JiangSu Province Hospital
NanJing, Jiangsu, China, 210029
WuXi People's Hospital
WuXi, Jiangsu, China, 214023
Sponsors and Collaborators
The First Affiliated Hospital with Nanjing Medical University
Investigators
Layout table for investigator information
Principal Investigator: Wei Xu, M.D., Ph.D. The First Affiliated Hospital with Nanjing Medical University

Publications:
Layout table for additonal information
Responsible Party: WEI XU, Professor, The First Affiliated Hospital with Nanjing Medical University
ClinicalTrials.gov Identifier: NCT01818908     History of Changes
Other Study ID Numbers: JSPH-HLH-001
First Posted: March 27, 2013    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019

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

Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphohistiocytosis, Hemophagocytic
Histiocytosis, Non-Langerhans-Cell
Histiocytosis
Lymphatic Diseases
Cyclophosphamide
Rituximab
Doxorubicin
Prednisone
Etoposide
Vincristine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antineoplastic Agents, Immunological
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents, Phytogenic