Treatment of Non Severe Hemophagocytosis Lymphohistiocytosis With ITACITINIB
NCT ID: NCT05063110
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
35 participants
INTERVENTIONAL
2022-05-03
2025-10-01
Brief Summary
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Detailed Description
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In this proof of concept study, because of the vital risk associated with severe HLH and the efficacy of Etoposide in this setting, we will first include only patients with moderate HLHs
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment arm
300 mg of ITACITINIB will be administrated per os every day for 30 days, dose with reduction to 200 mg per safety is allowed if AEs are observed or if co-administered a strong CYP3A inhibitor
Itacitinib
Administration of 300 mg of ITACITINIB per os every day for 30 days.
Interventions
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Itacitinib
Administration of 300 mg of ITACITINIB per os every day for 30 days.
Eligibility Criteria
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Inclusion Criteria
* Patient is willing to provide written informed consent prior to enrolment and agrees to follow the protocol
* Patient known to have systemic juvenile idiopathic arthritis are classified as having HLH
* Negative pregnancy test for woman of childbearing potential, woman of childbearing potential should have reliable contraception for the duration of the study
* Be either affiliated to, or a beneficiary of, a social security category
Exclusion Criteria
* Fibrinogen \< 0.50 g/l, platelets \<20G/L
* Indication to intensive care unit transfer on an organ failure requiring assistance (dialysis, Ventilation (assisted or VNI), shock regardless of the origin.
* Breastfeeding women
* Patient participating in another investigational therapeutic study
* Women with a positive pregnancy test or not willing to take contraceptive measures
* Known allergies, hypersensitivity, or intolerance to any of the ITACITINIB or excipients, or similar compounds
* Current or history of recurrent infections, including HBV, HCV
* Participants with active HBV or HCV infection that requires treatment or who are at risk for HBV reactivation (ie Positive HBs Ag serology)
* Candidates positive for HCV antibody and positive PCR RNA HCV
* HIV infection with positive viral charge
* Protected adults (including individual under guardianship by court order)
* Vulnerable adults, under a safeguard of justice measure
* Adults deprived of their liberty by judicial or administrative decision
* Persons under psychiatric care without their consent
* Persons admitted to social institution for purposes other this research
* Adults under legal protection (guardianship or curatorship)
* Persons unable to express their consent
18 Years
ALL
No
Sponsors
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Incyte Corporation
INDUSTRY
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Locations
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Hôpital Avicenne
Bobigny, Bobigny, France
Countries
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References
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Menasche G, Feldmann J, Fischer A, de Saint Basile G. Primary hemophagocytic syndromes point to a direct link between lymphocyte cytotoxicity and homeostasis. Immunol Rev. 2005 Feb;203:165-79. doi: 10.1111/j.0105-2896.2005.00224.x.
Pachlopnik Schmid J, Ho CH, Chretien F, Lefebvre JM, Pivert G, Kosco-Vilbois M, Ferlin W, Geissmann F, Fischer A, de Saint Basile G. Neutralization of IFNgamma defeats haemophagocytosis in LCMV-infected perforin- and Rab27a-deficient mice. EMBO Mol Med. 2009 May;1(2):112-24. doi: 10.1002/emmm.200900009.
Billiau AD, Roskams T, Van Damme-Lombaerts R, Matthys P, Wouters C. Macrophage activation syndrome: characteristic findings on liver biopsy illustrating the key role of activated, IFN-gamma-producing lymphocytes and IL-6- and TNF-alpha-producing macrophages. Blood. 2005 Feb 15;105(4):1648-51. doi: 10.1182/blood-2004-08-2997. Epub 2004 Oct 5.
Vainchenker W, Constantinescu SN. JAK/STAT signaling in hematological malignancies. Oncogene. 2013 May 23;32(21):2601-13. doi: 10.1038/onc.2012.347. Epub 2012 Aug 6.
Maschalidi S, Sepulveda FE, Garrigue A, Fischer A, de Saint Basile G. Therapeutic effect of JAK1/2 blockade on the manifestations of hemophagocytic lymphohistiocytosis in mice. Blood. 2016 Jul 7;128(1):60-71. doi: 10.1182/blood-2016-02-700013. Epub 2016 May 24.
Other Identifiers
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2021-000407-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
APHP 201454
Identifier Type: -
Identifier Source: org_study_id