Letzte Aktualisierung: 06.05.2026
Hämatologische Erkrankungen
Phoebus
Studieninformationen
Multizentrische, randomisierte, doppelblinde Phase-IIb-Studie zur Beurteilung von oralem MaaT033 als gepoolte fäkale mikrobiologische Therapie zur Vorbeugung von Komplikationen einer allogenen hämatopoetischen Stammzelltransplantation
Ziele
Primäres Prüfziel
To compare the efficacy of MaaT033 with its placebo on OS at 12 months after alloHCT
Sekundäre Prüfziele für die Behandlungsarme:
To evaluate MaaT033 efficacy in gut microbiota diversity restoration using alpha-diversity (Richness index) To evaluate the cumulative incidence of grade 2-4 acute GvHD within 6 months after alloHCT To evaluate the cumulative incidence of non-relapse mortality within 12 months after alloHCT
Design
Design
Phase
Zentren
Datenerhebung
Interventionsgruppen
Verblindung
Erkrankung
Diagnose
Diagnosenbeschreibung
Hämatologische Erkrankung, bei der eine allogene Stammzelltransplantation indiziert ist
Mutation
Patienten
Alter
Einschlusskriterien
Age ≥ 50 years old Presence of a hematologic malignancy for which an alloHCT is indicated with a reduced toxicity or reduced intensity conditioning regimen Patients with polynuclear neutrophils > 0.5 G/L Patients having received wide spectrum antibiotics within the last 90 days prior to inclusion Karnofsky index ≥ 70%
Ausschlusskriterien
Patients planned to receive a non-myeloablative conditioning regimen (2 Gray total body irradiation (TBI) +/- purine analog, fludarabine + cyclophosphamide or equivalent) Patients planned to receive a conventional myeloablative conditioning regimen (e.g. high dose cyclophosphamide and high dose TBI (≥10Gy); high dose busulfan (12.8 mg/kg IV) + high dose cyclophosphamide) Patients receiving a manipulated graft (in-vitro T-cell depletion) Patients planned to receive a conditioning regimen with alemtuzumab Patients planned to receive alloHCT with cord blood cells Patients planned to receive alloHCT from unrelated donor with >= 3/10 HLA-mismatches Patients receiving a large spectrum antibiotic at time of randomization
Therapie
Intervention
Substanz
| Prüfplancode | MPOH08 |
|---|---|
| EudraCT | - |
| Clinicaltrials.gov | NCT05762211 |
|---|---|
| ISRCTN | - |
| DRKS | - |
Zuständige Gesamtstudie
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Leiter der klinischen Prüfung (LKP)—
Studiengruppen/-zentrale
Kontakt Klinische Studien
CIO Aachen: Uniklinik RWTH Aachen, +49 (0) 241 80-85490
CIO Bonn: Uniklinik Bonn, +49 (0) 228 287-16036
CIO Köln: Uniklinik Köln, +49 (0) 221 478-0
CIO Düsseldorf: Uniklinik Düsseldorf, +49 (0) 211 81-04150 (Mo-Do)




