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CAR T-cell Therapy

Arm B for Lymphoma

Phase 2

Recruiting

Led By Neeraj Saini, MD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Is being planned to receive FDA approved standard of care anti-CD19 Axicabtagene Ciloleucel

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion; an average of 1 year.

Awards & highlights

Study Summary

This trial is trying to determine if adding a treatment called fecal microbiota transplantation (FMT) can help with the gastrointestinal side effects of antibiotics in patients receiving anti-CD19 chimeric antigen

Who is the study for?

This trial is for lymphoma patients who are undergoing CAR-T cell therapy and experiencing gut-related side effects from antibiotics. It's designed to see if fecal microbiota transplantation (FMT) can help with these issues.Check my eligibility

What is being tested?

The study is testing whether adding FMT to standard anti-CD19 CAR-T cell therapy can reduce gastrointestinal complications in lymphoma patients. This pilot trial will provide initial data on the effectiveness of this combination treatment.See study design

What are the potential side effects?

Potential side effects may include typical reactions related to chemotherapy and CAR-T therapies, such as nausea, fatigue, fever, and infection risk. FMT might cause bloating, diarrhea or introduce new infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My kidneys work well enough, with a creatinine clearance over 30 mL/min.

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I am planned to receive an FDA-approved CAR T-cell therapy.

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My white blood cell count is high enough for a specific treatment.

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I am 18 years old or older.

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My diagnosis is B-cell lymphoma confirmed by lab tests.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion; an average of 1 year.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion; an average of 1 year.

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; an average of 1 year. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Safety and adverse events (AEs)

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm BExperimental Treatment2 Interventions

Will receive no FMT therapy and only receive their scheduled chemotherapy and CAR-T cell therapy.

Group II: Arm AExperimental Treatment3 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fecal Microbiota Transplantation

2016

Completed Phase 2

~350

Chemotherapy

2003

Completed Phase 4

~3050

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,974 Previous Clinical Trials

1,789,436 Total Patients Enrolled

253 Trials studying Lymphoma

32,502 Patients Enrolled for Lymphoma

Neeraj Saini, MDPrincipal InvestigatorM.D. Anderson Cancer Center

1 Previous Clinical Trials

20 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available vacancies for potential participants in this research study?

"The information obtained from clinicaltrials.gov indicates that this particular clinical trial is not currently seeking participants. The initial posting date was on July 31, 2024, with the most recent update occurring on January 11, 2024. However, it is worth noting that there are presently a total of 1662 other ongoing clinical trials actively recruiting patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "Pilot Trial of Fecal Microbiota Transplantation for Lymphoma Patients Receiving Axicabtagene Ciloleucel Therapy.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06218602.

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