MaaT013 As Salvage Therapy in Ruxolitinib Refractory GI-aGVHD Patients (NCT04769895) | Clinical Trial Compass
Active — Not RecruitingPhase 3
MaaT013 As Salvage Therapy in Ruxolitinib Refractory GI-aGVHD Patients
Austria, Belgium66 participantsStarted 2022-03-25
Plain-language summary
MaaT013 showed interesting results in steroids and ruxolitinib-resistant aGVHD patients with gut involvement (55% ORR at D28) and 47% and 39% OS at 6 and 12 months respectively (Malard 2020), therefore warrant being tested as salvage therapy in steroid and JAK inhibitors-resistant GI-aGvHD patients. Given the absence of an approved 3rd line strategy or 2nd line strategy in ruxolitinib intolerant patients and the extremely poor prognosis of these patients, who are mostly left with no viable therapeutic option, a single-arm open-label design was proposed.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Age ≥ 18 years old
* Allo-HSCT with any type of donor, stem cell source, GVHD prophylaxis or conditioning regimen.
* Acute GvHD episode with GI involvement per MAGIC guidelines (= grades II to IV), with or without involvement of other organs
* Patients resistant to steroids AND either resistant to OR with intolerance to ruxolitinib OR with contra-indication to ruxolitinib:
Exclusion Criteria:
* Patients with known hypersensitivity to vancomycin or to any of the excipients listed in the corresponding SmPC
* Patients with active CMV colitis
* Patients who had previously received other lines of systemic aGvHD treatment other than CS and ruxolitinib.
* Grade II-IV hyper-acute GvHD
* Overlap chronic GvHD
* Relapsed/persistent malignancy requiring rapid immune suppression withdrawal.
* Active uncontrolled infection according to the attending physician
* Severe organ dysfunction unrelated to underlying GvHD, including:
Cholestatic disorders or unresolved veno-occlusive disease of the liver (defined as persistent bilirubin abnormalities not attributable to GvHD and ongoing organ dysfunction).
Clinically significant or uncontrolled cardiac disease including unstable angina, acute myocardial infarction within 6 months before Day 1 of study drug administration, New York Heart Association Class III or IV congestive heart failure, circulatory collapse requiring vasopressor or inotropic support, or arrhythmia that requires therapy.
Clinically significant respira…