Treatment of non severe Hemophagocytosis Lymphohistiocytosis with ITACITINIB a Phase II prospective trial

Phase 1

• Conditions: Adults patients having non severe HLH; Therapeutic area: Diseases [C] - Hemic and Lymphatic Diseases [C15]

• Registration Number: CTIS2024-513173-44-00
• Lead Sponsor: Assistance Publique Hopitaux De Paris

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-17
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Patients age >= 18 years, with front line or recurrent sporadic HLH, without or awaiting diagnosis of associated pathologies that may benefit from specific treatment, without severity criteria, without organ failure, Major criteria: (i) Cytological features of hemophagocytosis (ii) Fever (iii) Splenomegaly, Minor criteria: (i) Adenopathies (ii) Cytopenia> 2 lineages: - Haemoglobin < 9 g/dl, - Platelets < 100 000/mm3 - Neutrophils < 1000/mm3 (iii) Hypertriglyceridemia > 3 mmol/l and/or hypofibrigenemia < 1.5 g/l (iv) Ferritin>500 µg/l, HScore = 169, 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 if they met the following criteria: (i) Ferritin > 684 ng/mL and (ii) any 2 of the following: - Platelet count < 181 000/mm3, - ASAT > 48 UI/ml, - Triglyceride > 4 mmol/L, - Fibrinogen < 3.6 g/L, 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

Organ failure (at least one of those criteria): - Confusion, glasgow < 13, - Organic kidney failure requiring dialysis or KDIGO > 2, - Liver failure (Factor V < 50%), - Heart failure requiring catecholamines, - Respiratory failure requiring assisted ventilation, HIV infection with positive viral charge (note: in case of negative HIV antibody, it is not necessary to perform the PCR HIV RNA)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, Fibrinogen < 0.50 g/l, platelets <20G/L, Patient participating in another investigational therapeutic study, Breastfeeding women, 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 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 (note: in case of negative result of HCV antibody, it is not necessary to perform the PCR HCV RNA)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified