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Trial record 1 of 5 for:    PHOEBUS
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Oral Pooled Fecal Microbiotherapy to Prevent Allogeneic Hematopoietic Cell Transplantation Complications (PHOEBUS Trial)

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ClinicalTrials.gov Identifier: NCT05762211
Recruitment Status : Recruiting
First Posted : March 9, 2023
Last Update Posted : November 8, 2023
Sponsor:
Information provided by (Responsible Party):
MaaT Pharma

Study Description
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Brief Summary:
This randomized, placebo-controlled phase IIb study (PHOEBUS trial) aims to evaluate the activity of fecal microbiotherapy MaaT033 to improve survival through the prevention of transplant-related complications in eligible alloHCT patients

Condition or disease Intervention/treatment Phase
Transplant Complication Drug: Pooled allogeneic fecal microbiotherapy Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 387 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Multi-center Randomized, Double Blinded Phase IIb Trial Evaluating Oral Pooled Fecal Microbiotherapy MaaT033 to Prevent Allogeneic Hematopoietic Cell Transplantation Complications (PHOEBUS Trial)
Actual Study Start Date : October 31, 2023
Estimated Primary Completion Date : October 31, 2026
Estimated Study Completion Date : February 15, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Arms and Interventions
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Arm Intervention/treatment
Experimental: Oral pooled fecal microbiotherapy - MaaT033
3 capsules per day
 Drug: Pooled allogeneic fecal microbiotherapy
Capsule for oral use
Other Name: MaaT033
Placebo Comparator: Placebo capsule
3 capsules per day
 Drug: Placebo
Capsule for oral use


Outcome Measures
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Primary Outcome Measures :
  1. Overall survival [ Time Frame: 12 months post alloHCT ]
    To compare the efficacy of MaaT033 with its placebo on OS at 12 months after alloHCT


Secondary Outcome Measures :
  1. Restoration of gut microbiota diversity [ Time Frame: 12 months post alloHCT ]
    To evaluate MaaT033 efficacy in gut microbiota diversity restoration using alpha-diversity (Richness index)

  2. grade 2-4 acute GvHD [ Time Frame: 6 months post alloHCT ]
    To evaluate the cumulative incidence of grade 2-4 acute GvHD within 6 months after alloHCT

  3. grade 3-4 acute GvHD [ Time Frame: 12 months post alloHCT ]

    To evaluate the cumulative incidence of grade 3-4 severe acute GvHD within 12+

    + months after alloHCT


  4. Non-relapse mortality [ Time Frame: 12 months post alloHCT ]
    To evaluate the cumulative incidence of non-relapse mortality within 12 months after alloHCT

  5. Infectious-related mortality [ Time Frame: 12 months post alloHCT ]
    To evaluate the cumulative incidence of infectious-related mortality within 12 months after alloHCT

  6. GvHD-related mortality [ Time Frame: 12 months post alloHCT ]
    To evaluate the cumulative incidence of GvHD-related mortality within 12 months after alloHCT

  7. GRFS [ Time Frame: 12 months post alloHCT ]
    To evaluate GvHD-free relapse-free survival (GRFS) at 12 months after alloHCT

  8. Quality of life questionnaire [ Time Frame: 12 months post alloHCT ]
    To evaluate the Quality of Life (EORTC QLQ C30 questionnaire)

  9. Quality of life questionnaire [ Time Frame: 12 months post alloHCT ]
    To evaluate the Quality of Life (FACT-BMT questionnaire)

  10. Proportion of patients with severe infections [ Time Frame: 6 months after alloHCT ]
    To evaluate the proportion of patients with severe infections defined by NCI-CTCAE ≥ Grade 3 within 6 months after alloHCT

  11. Proportion of patients who have discontinued immune suppression therapies [ Time Frame: 12 months after alloHCT ]
    To evaluate the proportion of patients who have discontinued immune suppression therapies including standard of care GvHD prophylaxis and steroid treatment

  12. Time to platelet engraftment [ Time Frame: 12 months after alloHCT ]
    Time to the first of 3 consecutive days of absolute neutrophil counts ≥ 0.5 G/L after alloHCT

  13. Time to neutrophil engraftment [ Time Frame: 12 months after alloHCT ]
    Time to the first of 3 consecutive days of platelet counts ≥ 20 G/L after alloHCT

  14. Safety: incidence of AEs [ Time Frame: 12 months after alloHCT ]
    To evaluate MaaT033 safety


Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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%
  • 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)
  • 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
  • Patients planned to receive vedolizumab or abatacept for GvHD prophylaxis
  • Creatinine clearance <30 mL/min
  • Bilirubin or amino-transferases abnormalities contra-indicating alloHCT
  • Cardiac ejection fraction less than 40%
  • Pulmonary impairment with <50% lung carbon monoxide diffusing capacity (DLCO)
  • Pregnancy
  • Confirmed or suspected intestinal ischemia
  • Confirmed or suspected toxic megacolon or gastrointestinal perforation
  • Any history of gastro-intestinal surgery in the past 3 months
  • Any 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-IgG negative serology
  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05762211


Contacts
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Contact: Emilie Plantamura 0663590186 eplantamura@maat-pharma.com
Contact: Claire de Condé cdeconde@maat-pharma.com

Locations
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France
CHU Angers Recruiting
Angers, France
Contact: Sylvie François, MD         
CHU Caen Recruiting
Caen, France
Contact: Sylvain Chantepie, MD         
CHU Grenoble Recruiting
La Tronche, France
Contact: Martin Carré, MD         
Institut Paoli Calmettes Recruiting
Marseille, France
Contact: Raynier Devillier         
CHU Nantes Hôtel Dieu Recruiting
Nantes, France
Contact: Patrice Chevallier         
Hôpital St Antoine Recruiting
Paris, France
Contact: Florent Malard, MD, PhD         
Hôpital Haut-Lévêque Recruiting
Pessac, France
Contact: Clémence Médiavilla         
CHU Rennes - Hôpital Pontchaillou Recruiting
Rennes, France
Contact: Jean-Baptiste Méar, MD         
CHU St Etienne Recruiting
Saint-Priest-en-Jarez, France
Contact: Jérôme Cornillon, MD         
IUCT Toulouse Recruiting
Toulouse, France
Contact: Anne Huynh         
Germany
Universitätsklinikum Bonn Recruiting
Bonn, Germany
Contact: Tobias Holderried         
Universitätsklinikum Ulm Recruiting
Ulm, Germany
Contact: Elisa Sala, MD         
Sponsors and Collaborators
MaaT Pharma
Investigators
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Principal Investigator: Florent Malard, MD, PhD APHP
More Information
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Responsible Party: MaaT Pharma
ClinicalTrials.gov Identifier: NCT05762211    
Other Study ID Numbers: MPOH08
First Posted: March 9, 2023    Key Record Dates
Last Update Posted: November 8, 2023
Last Verified: November 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No