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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2024-00282 | Other Identifier | NCI-CTRP Clinical Registry |
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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.
Primary Objectives
Secondary Objectives
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental | 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. |
|
| Arm B | Experimental | Will receive no FMT therapy and only receive their scheduled chemotherapy and CAR-T cell therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fecal Microbiota Transplantation | Drug | Given by PO |
| |
| Chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and adverse events (AEs) | Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 | Through study completion; an average of 1 year. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Neeraj Saini, MD | Contact | (713) 792-4504 | nsaini@mdanderson.org |
| Name | Affiliation | Role |
|---|---|---|
| Neeraj Saini, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MD Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39441941 | Derived | Prasad R, Rehman A, Rehman L, Darbaniyan F, Blumenberg V, Schubert ML, Mor U, Zamir E, Schmidt S, Hayase T, Chang CC, McDaniel L, Flores I, Strati P, Nair R, Chihara D, Fayad LE, Ahmed S, Iyer SP, Wang M, Jain P, Nastoupil LJ, Westin J, Arora R, Turner J, Khawaja F, Wu R, Dennison JB, Menges M, Hidalgo-Vargas M, Reid K, Davila ML, Dreger P, Korell F, Schmitt A, Tanner MR, Champlin RE, Flowers CR, Shpall EJ, Hanash S, Neelapu SS, Schmitt M, Subklewe M, Francois-Fahrmann J, Stein-Thoeringer CK, Elinav E, Jain MD, Hayase E, Jenq RR, Saini NY. Antibiotic-induced loss of gut microbiome metabolic output correlates with clinical responses to CAR T-cell therapy. Blood. 2025 Feb 20;145(8):823-839. doi: 10.1182/blood.2024025366. |
| Label | URL |
|---|---|
| MD Anderson Cancer Center | View source |
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| ID | Term |
|---|---|
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
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| ID | Term |
|---|---|
| D000069467 | Fecal Microbiota Transplantation |
| D004358 | Drug Therapy |
| D016219 | Immunotherapy, Adoptive |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D019264 | Adoptive Transfer |
| D007116 | Immunization, Passive |
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| Procedure |
Given by Infusion |
|
| CAR-T Therapy | Procedure | Given by Infusion |
|
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D007114 |
| Immunization |
| D007167 | Immunotherapy |
| D056747 | Immunomodulation |
| D007158 | Immunologic Techniques |
| D008919 | Investigative Techniques |