Klinische Studie

Evaluation of MaaT013 as Salvage Therapy in Acute GvHD Patients with Gastrointestinal Involvement, Refractory to Ruxolitinib; a Multi-Center Open -Label Phase III Trial.(ARES)Evaluation of the Efficacy of MaaT013 as Salvage Therapy in Acute GvHD Patients with Gastrointestinal Involvement, Refractory ro Ruxolitinb; a Muli-iCenter Open-Label Phase III Trial.
EUDRACT2021-001841-11
NCTNCT04769895
DRKS-
Krankheitsentität(en) Blut (Leukämie), Lymphknoten, Knochenmark
Darm (Dickdarm, Mastdarm)
übergreifende Studien
StudientypInterventionsstudiePhase III
Wesentliche EinschlusskriterienAge<= 18 years or older Allo-HSCT with any type of donor, stem cell source, GvHD prophylaxis or conditioning regimen Patients who devleop a GvHD episode with GI involvement per MAGIC guidelines with or without involvement of other organs Patienst resistent to steroids AND either resistant to OR with intolerance to ruxolitinib. Diagnosis must be confirmed within 48h prior to study pre-treatment start. Signature of informed and written consent by the subject or by the subject`s legally aceptable representative
Wesentliche AusschlusskriterienPatients woh had previously received other lines of systemic aGvHD treatment other than CS and ruxolitinb. Grade II-IV hyoer-acute GvHD as defined by the MD Anderson´s criteria Overlap chronic GvHD as defined by the NIH Consensus Criteria Relapsed/ persistant malignanccy requiring rapid immune suppression withdrawel. Liver stage 4 and / or skin stage 4 aGvHD.
Statusrekrutierend
Ansprechpartner & KontaktUniversitätsklinikum RegensburgInnere Medizin IIIStudienzentrale0941 9441557studienzentrale.med3(at)ukr.de
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