TerminatedNot Applicable

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

Stopped: The PI resigned the institute, and the rest investigators at the institute decided to terminate the study.

South Korea12 participantsStarted 2012-03

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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

What they're measuring

overall survival rate

Timeframe: 1-year

Trial details

NCT IDNCT01547143

SponsorAsan Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-05

View on ClinicalTrials.gov More Hemophagocytic Lymphohistiocytosis trials