Treatment Protocol for Hemophagocytic Lymphohistiocytosis 2004

PHASE3CompletedINTERVENTIONAL
Enrollment

368

Participants

Timeline

Start Date

January 31, 2004

Primary Completion Date

December 31, 2011

Study Completion Date

December 31, 2017

Conditions
Hemophagocytic Lymphohistiocytosis
Interventions
DRUG

Dexamethasone

"10 mg/m2 daily wk 1-2 5 mg/m2 daily wk 3-4 2.5 mg/m2 daily wk 5-6 1.25 mg/m2 daily wk 7 Steroids tapered wk 8~If continuation:~Pulses every 2nd wk, 10 mg/m2 for 3 days"

DRUG

Etoposide

"150 mg/m2 iv twice/wk (wk 1-2) 150 mg/m2 iv once/wk (wk 3-8)~If continuation:~150 mg/m2 iv, every 2nd wk"

DRUG

Cyclosporin

"WK 1-8:~\- Aim at around 200 microgram/L (trough value). Start: 6 mg/kg daily (divided in 2 daily doses) wk 1, if kidney function is normal.~If continuation:~\- Aim for around 200 microgram/L. Monitor GFR."

PROCEDURE

Intrathecal therapy

"If at 2 wks there are progressive neurological symptoms or if an abnormal CSF (cell count and protein) has not improved, then give 4 wkly intrathecal inj. Be aware that some pat may have increased intracranial pressure.~Methotrexate: \<1 yr 6 mg, 1-2 yrs 8 mg, 2-3 yrs 10 mg, \>3 yrs 12 mg. Prednisolone: \<1 yr 4 mg, 1-2 yrs 6 mg, 2-3 yrs 8 mg, \>3 yrs 10 mg."

PROCEDURE

Stem cell transplant

The SCT procedure is up to the treating physician. However, a suggested regimen is provided.

Trial Locations (1)

S-171 76

Childhood Cancer Research Unit, Karolinska Hospital, Stockholm

All Listed Sponsors
collaborator

Meyer Children's Hospital IRCCS

OTHER

collaborator

Leiden University Medical Center

OTHER

collaborator

Children's Hospital Medical Center, Cincinnati

OTHER

collaborator

Ehime University Graduate School of Medicine

OTHER

collaborator

Universitätsklinikum Hamburg-Eppendorf

OTHER

collaborator

Baylor College of Medicine

OTHER

collaborator

Great Ormond Street Hospital for Children NHS Foundation Trust

OTHER

collaborator

St. Anna Kinderkrebsforschung

OTHER

collaborator

Hospital de Cruces

OTHER

collaborator

Hospital JP Garrahan

OTHER_GOV

lead

Karolinska University Hospital

OTHER

NCT00426101 - Treatment Protocol for Hemophagocytic Lymphohistiocytosis 2004 | Biotech Hunter | Biotech Hunter