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New treatment option for Lymphoma
Official title Pilot Trial of Fecal Microbiota Transplantation for Lymphoma Patients Receiving Axicabtagene Ciloleucel Therapy.
ClinicalTrials.gov ID: NCT06218602
What this study is testing
What is Fecal Microbiota Transplantation?
Fecal Microbiota Transplantation is an investigational medicine, being studied as a potential treatment for lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- At least 18 years of age on the day of signing informed consent.
- Histologically/cytologically confirmed diagnosis of B-cell lymphomas.
- Is being planned to received FDA approved standard of care anti-CD19 Axicabtagene Ciloleucel.
- Participants must have received or is receiving high-risk broad-spectrum antibiotics for minimum of two days within 180 days of scheduled...
- An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. Evaluation of ECOG is to be performed within 7 days prior to the date of...
You likely can't join if
- If participant received major surgery within last 4 weeks, they must have recovered adequately from the toxicity and/or complications from the...
- Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the...
- Has a diagnosis of primary immunodeficiency (excluding IgA deficiency).
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with...
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Pregnant or nursing women
See the full eligibility criteria
- At least 18 years of age on the day of signing informed consent.
- Histologically/cytologically confirmed diagnosis of B-cell lymphomas.
- Is being planned to received FDA approved standard of care anti-CD19 Axicabtagene Ciloleucel.
- Participants must have received or is receiving high-risk broad-spectrum antibiotics for minimum of two days within 180 days of scheduled Axicabtagene ciloleucel infusion. High-risk broad-spectrum antibiotics include...
- An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. Evaluation of ECOG is to be performed within 7 days prior to the date of signing study consent.
- The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.
- Absolute neutrophil counts should be greater than 1000/ul at the time of administration of fecal enema.
- Adequate hepatic function defined by a total bilirubin level ≤ 1.5 ≤ x the upper limit of normal (ULN)[except if Gilberts syndrome and then total bilirubin ≤ 3x is allowed], an AST, level ≤ 2.5 x ULN, and an ALT level ≤...
- Adequate renal function defined by an estimated creatinine clearance \>30 mL/min according to the Cockcroft-Gault formula or by a creatinine clearance measurement from a 24-hour urine collection.
- Highly effective contraception for both male and female people if the risk of conception exists. Highly effective contraception must be used 30 days prior to first study-drug administration, for the duration of trial...
- If participant received major surgery within last 4 weeks, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment.
- Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow...
- Has a diagnosis of primary immunodeficiency (excluding IgA deficiency).
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is...
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Pregnant or nursing women
- For women of childbearing age, a serum pregnancy test will be required within 72 hours prior to enrollment. If the serum test is positive, patient will not be allowed to enroll in the trial.
- Participants with history of irritable bowel disease and inflammatory bowel disease will be excluded from clinical trial.
- Participants with difficulties in oral administration or at risk of aspiration (e.g., neurological issues)
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.