Pilot Trial of Fecal Microbiota Transplantation for Lymphoma Patients Receiving Axicabtagene Ciloleucel Therapy.

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT06218602
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Fecal Microbiota Transplantation — DRUG
    Given by PO
  • Chemotherapy — PROCEDURE
    Given by Infusion
  • CAR-T Therapy — PROCEDURE
    Given by Infusion

Study Details

To find out if adding treatment with fecal microbiota transplantation (FMT) is effective at treating gut-related side effects of antibiotic treatment in participants who are receiving standard therapy with anti-CD19 chimeric antigen receptor T-cell (CAR-T cell) therapy.

Key Dates

Start date
Feb 19, 2024
Status verified
Apr 2026
Primary completion
Aug 1, 2026
Completion
Aug 1, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A
    Will receive FMT therapy (both as a colonoscopy / FMT procedure and as capsules taken by mouth) plus the scheduled chemotherapy and CAR-T cell therapy.
  • Experimental: Arm B
    Will receive no FMT therapy and only receive their scheduled chemotherapy and CAR-T cell therapy.

Primary Outcome Measure

Safety and adverse events (AEs) [ Time Frame: Through study completion; an average of 1 year. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
MD Anderson Cancer CenterHoustonTexas77030
Neeraj Saini, MD
[email protected]
713-792-4504
Neeraj Saini, MD (PRINCIPAL_INVESTIGATOR)

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By research site
MD Anderson Cancer Center· Houston, TX

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