A multi-center randomized, double blinded phase IIb trial evaluating oral pooled fecal microbiotherapy MaaT033 to prevent allogeneic hematopoietic cell transplantation complications

Phase 1

Recruiting

• Conditions: Patients with hematologic malignancies and undergoing allogenic hematopoietic cell transplantation; MedDRA version: 22.0Level: PTClassification code: 10067859Term: Allogenic stem cell transplantation Class: 100000004865; Therapeutic area: Diseases [C] - Hemic and Lymphatic Diseases [C15]

• Registration Number: CTIS2022-501831-18-00
• Lead Sponsor: Maat Pharma

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-17
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 277

Inclusion Criteria

Patients aged 50 years or older (= 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%, Availability of a sibling donor, an unrelated stem-cell donor or a familial haploidentical donor, Written informed consent

Exclusion Criteria

Patients planned to receive a non-myeloablative conditioning regimen (2 Gray total body irradiation (TBI) +/- purine analog, fludarabine + cyclophosphamide or equivalent), Documented creatinine clearance <30 mL/min, Documented cardiac ejection fraction less than 40%, Documented pulmonary impairment with <50% lung carbon monoxide diffusing capacity (DLCO), Pregnancy, Documented confirmed or suspected intestinal ischemia, Documented confirmed or suspected toxic megacolon, bowel obstruction or gastrointestinal perforation, Any documented history of gastro-intestinal surgery in the past 3 months, Any documented history of chronic digestive disease (Crohn’s disease, ulcerative colitis, inflammatory bowel disease, or other relevant digestive condition according to physician’s judgement), Known allergy or intolerance to trehalose or maltodextrin, Patients with EBV-negative IgG serology, Documented bilirubin or amino-transferases abnormalities contra-indicating alloHCT, 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., Vulnerable patients such as: persons deprived of liberty, persons in Intensive Care Unit unable to provide informed consent prior to the intervention, persons under legal protection according to the French law., 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 (CAMPATH®), 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, Patients planned to receive vedolizumab or abatacept for GvHD prophylaxis

Study & Design

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