Status:
ACTIVE_NOT_RECRUITING
MaaT013 As Salvage Therapy in Ruxolitinib Refractory GI-aGVHD Patients
Lead Sponsor:
MaaT Pharma
Conditions:
Acute Graft Versus Host Disease in Intestine
Steroid Refractory GVHD
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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), therefor...
Detailed Description
Standard first-line therapy for the treatment of acute GVHD involves corticosteroids, usually methyl-prednisolone at a dose of 2 mg/kg per day (Martin PJ R. J., 2012; Van Lint MT, 1998). Despite initi...
Eligibility Criteria
Inclusion
- 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
- 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 respiratory disease that requires mechanical ventilation support or 50% oxygen.
- Current or past veno-occlusive disease or other uncontrolled complication unless otherwise agreed in writing by the sponsor.
- Absolute neutrophil count \<500/µL for 3 consecutive days. Use of growth factor supplementation is allowed.
- Absolute platelet count \< 10 000/µL. Use of platelet infusion is allowed.
- Patient with negative IgG EBV serology.
- Current or past evidence of toxic megacolon, bowel obstruction or gastrointestinal perforation.
- Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the subject; or interfere with interpretation of study data.
- Known allergy or intolerance to trehalose or maltodextrin.
- Vulnerable patients such as: minors, persons deprived of liberty, persons in Intensive Care Unit unable to provide informed consent prior to the intervention.
- Females of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication. Females of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile or abstain from procreative sexual activity for the course of the study. Females of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \>1 year. Males should agree to abstain from procreative sexual activity starting with the first dose of study therapy through the end of the study.
- Other ongoing interventional protocol that might interfere with the current study's primary endpoint.
Key Trial Info
Start Date :
March 25 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2025
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT04769895
Start Date
March 25 2022
End Date
November 1 2025
Last Update
October 17 2024
Active Locations (50)
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1
Medizinische Universität Innsbruck
Innsbruck, Austria
2
Ordensklinikum Linz Elisabethinen
Linz, Austria
3
Algemeen Ziekenhuis Sint-Jan Brugge-Oostende - Campus Sint-Jan
Bruges, Belgium
4
Cliniques Universitaires Saint-Luc
Brussels, Belgium