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Pilot Study of First-line Immunosuppressive Therapy Combined With Etoposide and Allogeneic Hematopoietic Cell Transplantation in Refractory/Reactivated Cases for Hemophagocytic Lymphohistiocytosis (HLH) in Adult Patients


N/A
18 Years
80 Years
Open (Enrolling)
Both
Hemophagocytic Lymphohistiocytosis

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Trial Information

Pilot Study of First-line Immunosuppressive Therapy Combined With Etoposide and Allogeneic Hematopoietic Cell Transplantation in Refractory/Reactivated Cases for Hemophagocytic Lymphohistiocytosis (HLH) in Adult Patients


Inclusion Criteria:



- Patients whose clinical findings satisfy 5 or more criteria out of the following 8
ones

1. Fever ≥ 38.5 ℃ for ≥ 7 days

2. Splenomegaly ≥ 3 FB below left subcostal margin

3. Cytopenias affecting ≥ 2 of 3 lineages in PB Hb < 9 g/L Platelet < 100 x 109 /L
ANC < 1.0 x 109 /L

4. Hypertriglyceridemia and/or hypofibrinogenemia (fasting triglycerides ≥ 265
mg/dL, fibrinogen ≤ 1.5 g/L)

5. Hemophagocytosis in BM or spleen or LN

6. Low or absent NK-cell activity ( according to local laboratory reference)

7. Serum-ferritin ≥ 500 mcg/L

8. Soluble CD25(sIL-2 receptor) ≥ 2,400 U/ml

- 18 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.

Exclusion Criteria:

- 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)

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

overall survival rate

Outcome Time Frame:

1-year

Safety Issue:

No

Principal Investigator

Dae-Young Kim, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Asan Medical Center

Authority:

South Korea: Institutional Review Board

Study ID:

AMC-H-72

NCT ID:

NCT01547143

Start Date:

March 2012

Completion Date:

February 2016

Related Keywords:

  • Hemophagocytic Lymphohistiocytosis
  • Secondary hemophagocytic lymphohistiocytosis of adults
  • Lymphohistiocytosis, Hemophagocytic

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