Poop pills may help lymphoma patients tolerate powerful cancer treatment
NCT ID NCT06218602
First seen Jun 27, 2026 · Last updated Aug 18, 2026 · Updated 4 times
Summary
This study tests whether fecal microbiota transplantation (FMT) can reduce gut-related side effects from antibiotics in 40 adults with B-cell lymphoma who are receiving standard CAR-T cell therapy. Participants will receive FMT alongside their cancer treatment to see if it improves safety and tolerability. The goal is to make the cancer therapy easier to complete without severe digestive issues.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2024
- Expected to finish
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Aug 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. At least 18 years of age on the day of signing informed consent. 2. Histologically/cytologically confirmed diagnosis of B-cell lymphomas. 3. Is being planned to received FDA approved standard of care anti-CD19 Axicabtagene Ciloleucel. 4. 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 carbapenems (meropenem, imipenem, doripenem), anti-pseudomonal antibiotics (cefepime, piperacillin-tazobactam, ceftazidime) or anaerobic antibiotics including metronidazole, clindamycin, amoxicillin-sulbactam. 5. 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. 6. The participant (or legally acceptable representative if applicable) provides written informed consent for the trial. 7. Absolute neutrophil counts should be greater than 1000/ul at the time of administration of fecal enema. 8. 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 ≤ 2.5 x ULN. If liver metastases are present, then AST and ALT levels must be ≤ 4 x ULN 9. 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. 10. Highly effective contraception for both male and female subjects 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 treatment, and for at least for 12 months after treatment for females and 4 months after treatment for males. Should a female patient (or male participant's sexual partner) become pregnant or should either the female patient (or male participant's partner) suspect she is pregnant while the participant's study-participation is ongoing, the treating physician should be informed immediately. Exclusion Criteria: 1. 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. 2. 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 fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed. 3. Has a diagnosis of primary immunodeficiency (excluding IgA deficiency). 4. 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 not in the study subject's best interest to participate, in the opinion of the treating investigator. 5. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. 6. Pregnant or nursing women 7. 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. 8. Participants with history of irritable bowel disease and inflammatory bowel disease will be excluded from clinical trial. 9. Participants with difficulties in oral administration or at risk of aspiration (e.g., neurological issues)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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MD Anderson Cancer Center
RECRUITINGHouston, Texas, 77030, United States
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Other studies related to the condition(s) this trial covers.
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- Do social factors decide who completes lymphoma treatment?
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