Trial of DA-EPOCH Regimen for NHL With HLH
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2013 by The First Affiliated Hospital with Nanjing Medical University.
Recruitment status was: Recruiting
Information provided by (Responsible Party):
WEI XU, Jiangsu Province Hospital
First received: March 23, 2013
Last updated: NA
Last verified: March 2013
History: No changes posted
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
NHL With Hemophagocytic Lymphohistiocytosis
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Clinical Study of Dose-adjusted EPOCH Regimen for Non-Hodgkin's Lymphoma With Hemophagocytic Lymphohistiocytosis
Primary Outcome Measures:
Secondary Outcome Measures:
- progression free survival [ Time Frame: one year ] [ Designated as safety issue: No ]
progression free survival after treatment of DA-EPOCH regimen
- overall survival [ Time Frame: one year ] [ Designated as safety issue: No ]
overall survival after treatment of DA-EPOCH regimen
- Number of Participants with Adverse Events [ Time Frame: up to 30 days after last dose of treatment ] [ Designated as safety issue: Yes ]
Number of Participants with Adverse Events, and evaluated standard is according to common terminology criteria adverse events(CTCAE) version 4.0
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||October 2013 (Final data collection date for primary outcome measure)
Etoposide 50 mg/m2/day CI24h d1-d4; Doxorubicin 10 mg/m2/day CI24h d1-d4; Vincristine 0.4mg/m2/day CI24h d1-d4;
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.
- Infused agents
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.
|Ages Eligible for Study:
||15 Years to 80 Years (Child, Adult, Senior)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Histologically confirmed non-Hodgkin's lymphoma;
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 ;
- New-diagnosed and untreated;
- Understand and voluntarily sign an informed consent form, able to adhere to the study visit schedule and other protocol requirements.
.At least 3 of 4:
- Cytopenias (minimum 2 cell lines reduced)
. And at least 1 of 4:
- ↑ Ferritin
- ↑ sIL2Rα (age based)
- Absent or very decreased NK function 4. Other results supportive of HLH diagnosis:
- Primary HLH.
- HLH from rheumatic disorder (such as SLE, AOSD, antiphospholipid antibody syndrome)
- Pregnancy (as determined by serum or urine test) or active breast feeding
- Concomitant malignancy other than non-Hodgkin's lymphoma and need to treat;
- Concomitant with other hematologic diseases(such as leukemia,hemophilia primary myelofibrosis) which investigator 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01818908
|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 |
The First Affiliated Hospital with Nanjing Medical University
||Wei Xu, M.D., Ph.D.
||The First Affiliated Hospital with Nanjing Medical University
Wilson WH, Grossbard ML, Pittaluga S, Cole D, Pearson D, Drbohlav N, Steinberg SM, Little RF, Janik J, Gutierrez M, Raffeld M, Staudt L, Cheson BD, Longo DL, Harris N, Jaffe ES, Chabner BA, Wittes R, Balis F. Dose-adjusted EPOCH chemotherapy for untreated large B-cell lymphomas: a pharmacodynamic approach with high efficacy. Blood. 2002 Apr 15;99(8):2685-93.
Henter JI, Horne A, Aricó M, Egeler RM, Filipovich AH, Imashuku S, Ladisch S, McClain K, Webb D, Winiarski J, Janka G. HLH-2004: Diagnostic and therapeutic guidelines for hemophagocytic lymphohistiocytosis. Pediatr Blood Cancer. 2007 Feb;48(2):124-31.
Wilson WH, Dunleavy K, Pittaluga S, Hegde U, Grant N, Steinberg SM, Raffeld M, Gutierrez M, Chabner BA, Staudt L, Jaffe ES, Janik JE. Phase II study of dose-adjusted EPOCH and rituximab in untreated diffuse large B-cell lymphoma with analysis of germinal center and post-germinal center biomarkers. J Clin Oncol. 2008 Jun 1;26(16):2717-24. doi: 10.1200/JCO.2007.13.1391.
||WEI XU, Professor, Jiangsu Province Hospital
History of Changes
|Other Study ID Numbers:
|Study First Received:
||March 23, 2013
||March 23, 2013
||China: Ministry of Health
Keywords provided by The First Affiliated Hospital with Nanjing Medical University:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 09, 2016
Physiological Effects of Drugs
Antineoplastic Agents, Alkylating
Molecular Mechanisms of Pharmacological Action
Topoisomerase II Inhibitors
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents, Phytogenic