Pilot Study of Etoposide-based Therapy and Hematopoietic Cell Transplantation for Hemophagocytic Lymphohistiocytosis

NCT01547143 | Terminated

• 1 other identifier: AMC-H-72
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators would like to propose a pilot study evaluating the efficacy of etoposide combined with immunosuppressive agents for adult secondary hemophagocytic lymphohistiocytosis (HLH), in order to prove out whether the modification of previous HLH-94 or HLH-2004 protocol for childhood patients can improve the outcome and decrease the toxicities. The results of this pilot study will be a base of a more-improved phase-2 protocol.

Conditions

Hemophagocytic Lymphohistiocytosis

Keywords

Secondary hemophagocytic lymphohistiocytosis of adults

Outcome Measures

Primary Outcomes (1)

• overall survival rate

  1-year

Secondary Outcomes (12)

• Complete response rate

  28 days

• Complete response rate

  56 days

• Complete response rate

  3 months

• Partial response rate

  28 days

• Partial response rate

  56 days

Study Arms (1)

IST and/or alloHCT

EXPERIMENTAL

Patients who are newly diagnosed as HLH by HLH-2004 criteria, excluding those with HLH owing to malignancy or rheumatic disorder.

Drug: IST and/or alloHCT

Interventions

IST and/or alloHCT DRUG

1\) Patients will be categorized by their initial serum ferritin level. 1. Mild ( ferritin\<3,000 μg/L): close observation 2. Moderate (ferritin: 3,000-10,000 μg/L): 1. Initiation : cyclosporine 3mg/kg p.o.bid + dexamethasone 10mg/m2/d po. or i.v. (D1-3) 2. continuation: cyclosporine 3mg/kg p.o. bid (D4-56) + dexamethasone 10mg/m2/d (D4-14), then tapering. 3. Severe (ferritin\>10,000 μg/L): 1. initiation : etoposide 100mg/m2/d i.v. + cyclosporine 2mg/kg i.v. q 12hours + dexamethasone 20mg/m2/d i.v. (D1-3) 2. continuation : etoposide 100mg/m2/day weekly (D15-49) + cyclosporine 2mg/kg i.v. q 12 hours? ? po. (D4-56) + dexamethasone 10mg/m2/d (D4-14), 5mg/m2/d (D15-28), 2.5mg/m2/d (D29-42), 1.25mg/m2/d (D43-56), then tapering off. 2\) AlloHCT for refractory or reactivated cases.

Also known as: Etoposide, Cyclosporine: Cipol, Dexamethasone, IV gammaglobulin

IST and/or alloHCT

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients whose clinical findings satisfy 5 or more criteria out of the following 8 ones
• Fever ≥ 38.5 ℃ for ≥ 7 days
• Splenomegaly ≥ 3 FB below left subcostal margin
• 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
• years of age and over.
• All patients (or his/her family when the patient cannot sign the consent form because of his/her general conditions) give written informed consent according to guidelines at institution's committee on human research.

You may not qualify if:

• HLH from malignancy (such as lymphoma, myeloma, leukemia, and other solid tumor)
• HLH from rheumatic disorder (such as SLE, AOSD, antiphospholipid antibody syndrome)
• Patients with psychiatric disorder or mental deficiency severe as to make compliance with the treatment unlike, and making informed consent impossible
• Nursing women, pregnant women, women of childbearing potential who do not want adequate contraception
• Male patient who reject the methods of avoiding pregnancy via methods such as abstinence, barrier method (condom etc).
• Patients with a diagnosis of prior malignancy unless disease-free for at least 5 years following therapy with curative intent (except curatively treated nonmelanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia)

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical center, University of Ulsan College of Medicine

Seoul, South Korea

Location

Related Publications (47)

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MeSH Terms

Conditions

Lymphohistiocytosis, Hemophagocytic

Interventions

Etoposide; Dexamethasone

Condition Hierarchy (Ancestors)

Histiocytosis, Non-Langerhans-Cell; Histiocytosis; Lymphatic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated

Study Officials

• Dae-Young Kim, MD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 29, 2012
• First Posted: March 7, 2012
• Study Start: March 1, 2012
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: July 20, 2018

Record last verified: 2018-07

Locations

KR (1)