Treatment Protocol for Hemophagocytic Lymphohistiocytosis 2004
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|ClinicalTrials.gov Identifier: NCT00426101|
Recruitment Status : Active, not recruiting
First Posted : January 24, 2007
Last Update Posted : March 14, 2017
|Condition or disease||Intervention/treatment||Phase|
|Hemophagocytic Lymphohistiocytosis||Drug: Dexamethasone Drug: Etoposide Drug: Cyclosporin Procedure: Intrathecal therapy Procedure: Stem cell transplant||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||HLH-2004 Treatment Protocol|
|Study Start Date :||January 2004|
|Primary Completion Date :||December 2011|
|Estimated Study Completion Date :||December 2017|
Experimental: Etoposide, Dexamethasone, Cyclosporin A plus IT MTX & Steroids
As compared to the HLH-94 treatment, the main changes are that
Drugs, dosage, frequency and duration are described in the paragraph "Interventions" below.
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
Pulses every 2nd wk, 10 mg/m2 for 3 days
150 mg/m2 iv twice/wk (wk 1-2) 150 mg/m2 iv once/wk (wk 3-8)
150 mg/m2 iv, every 2nd wk
Procedure: Intrathecal therapy
- 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.
- Aim for around 200 microgram/L. Monitor GFR.
Procedure: Stem cell transplant
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.
The SCT procedure is up to the treating physician. However, a suggested regimen is provided.
- Survival [ Time Frame: 1-year after diagnosis ]
- Late effects [ Time Frame: 5-years after diagnosis ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00426101
|Childhood Cancer Research Unit, Karolinska Hospital|
|Stockholm, Sweden, S-171 76|
|Principal Investigator:||Jan-Inge Henter, MD, PhD||Karolinska Institutet|