Prospective Evaluation Of Delayed Effects Of Pediatric Car T Cell Therapy
Part of paid clinical trials in Aurora, Colorado.
- Sponsor
- St. Jude Children's Research Hospital
- Study ID
- NCT06579469
- Status
- Recruiting
Conditions
- B-ALL
- Hematologic Malignancy
- Solid Tumor
Eligibility Criteria
- Sex
- ALL
- Age
- N/A - 30 Years
- Healthy Volunteers
- Not accepted
Study Details
This study is being done to learn more about the short-term and long-term side effects of CAR-T cell therapy. Specifically, researchers want to know how often patients get infections, have delays in recovering blood cell counts and/or have damage to the nervous system.
Key Dates
- First listed
- Aug 30, 2024
- Start date
- Jan 20, 2026
- Status verified
- Jun 2026
- Primary completion
- Mar 31, 2027
- Completion
- Mar 31, 2029
Study Design
- Enrollment
- 100 participants (estimated)
Arms
- Arm: B cell acute lymphoblastic leukemia (B cell acute lymphoblastic leukemia (B-ALL) ) cohortB-ALL participants who have received initial CAR T cell therapy within the last 1-3 months.
- Arm: Other hematologic malignancyOther hematologic malignancy participants who have received initial CAR T cell therapy within the last 1-3 months.
- Arm: Solid tumor (ST)ST participants who have received initial CAR T cell therapy within the last 1-3 months.
Primary Outcome Measure
Presence of bone marrow dysfunction (BMD) [ Time Frame: Within 6 months post CAR T-cell therapy ]
Central Contacts
- Rebecca Epperly, MD888-226-4343
Locations (6)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Childrens Hospital of Colorado | Aurora | Colorado | 80045 | Hesham Eissa, MD, MSc (PRINCIPAL_INVESTIGATOR) |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | Regina Myers, MD (PRINCIPAL_INVESTIGATOR) |
| St. Jude Children's Research Hospital | Memphis | Tennessee | 38105 | Rebecca Epperly, MD (PRINCIPAL_INVESTIGATOR) |
| Primary Children's Hospital | Salt Lake City | Utah | 84113 | Joseph G Dolan, MD (PRINCIPAL_INVESTIGATOR) |
| Seattle Childrens Hospital | Seattle | Washington | 98105 | Mallory Taylor, MD (PRINCIPAL_INVESTIGATOR) |
| Children's Hospital of Wisconsin. | Milwaukee | Wisconsin | 53226 | Amy Moskop, MD (PRINCIPAL_INVESTIGATOR) |
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