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NCT05440409 · ClinicalTrials.gov registry record
CAR-Multicenter Analysis (CAR-MA): Retrospective Study to Characterize CAR T-cell Outcomes and Related Toxicities in Children and Young Adults With B-ALL
A clinical trial of Lymphoblastic Leukemia, Acute, Childhood and Leukemia, Acute Lymphoblastic, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- 57
- Enrollment target
- 1
- Study location
NCT05440409 is a study of Lymphoblastic Leukemia, Acute, Childhood and Leukemia, Acute Lymphoblastic that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 57 participants, above the 32-participant average among 4 other Lymphoblastic Leukemia, Acute, Childhood trials with a reported enrollment target (78% higher). The trial reports 1 study location across 1 state.
The verdict
NCT05440409, a study of Lymphoblastic Leukemia, Acute, Childhood and Leukemia, Acute Lymphoblastic, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- 57 participants
- Enrollment target
- 1
- Study location
Study Summary
Study Description: This retrospective protocol focuses on characterizing clinical outcomes and toxicities following CAR T-cell therapy. Objectives: Primary To evaluate the Response Free Survival (RFS) at 6 months following CD19 CAR stratified by prior blinatumomab vs no prior blinatumomab To retrospectively evaluate outcomes following CAR T-cell therapy across children and young adults with B-ALL Secondary To evaluate the RFS at 12 months following CD19 CAR stratified by prior blinatumomab vs no prior blinatumomab and other immunotherapy. To evaluate the incidence of CD19 negative versus CD19 positive relapse following CD19 CAR stratified by prior blinatumomab vs no prior blinatumomab. To evaluate the Complete Response (CR) rate following CD19 CAR stratified by prior blinatumomab vs no prior blinatumomab. To evaluate the Minimal Residual Disease (MRD) negative remission rate following CD19 CAR stratified by prior blinatumomab vs no prior blinatumomab. Study Population and Source of Data: Subjects who were less than \< 25 years of age at the time of diagnosis and received a CAR T-cell product for B-ALL.
Conditions Studied
Study Locations (1)
Maryland
- National Cancer Institute (NCI) - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2021-10-14 |
| Est. Completion | 2024-10-29 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05440409
The ClinicalTrials.gov registry entry for NCT05440409 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 57 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 32-participant average among 4 other Lymphoblastic Leukemia, Acute, Childhood trials with a reported enrollment target (78% higher). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Lymphoblastic Leukemia, Acute, Childhood appearing as the primary indexed condition, and to 0 interventions.
NCT05440409 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT05440409 about?
NCT05440409 is a clinical study titled "CAR-Multicenter Analysis (CAR-MA): Retrospective Study to Characterize CAR T-cell Outcomes and Related Toxicities in Children and Young Adults With B-ALL". Study Description: This retrospective protocol focuses on characterizing clinical outcomes and toxicities following CAR T-cell therapy. Objectives: Primary To evaluate the Response Free Survival (RFS) at 6 months following CD19 CAR stratified by prior blinatumomab vs no prior blinatumomab To re...
What is the current status of trial NCT05440409?
This trial is currently completed. The enrollment target is 57 participants. The study started on 2021-10-14. Estimated completion is 2024-10-29.
What conditions does trial NCT05440409 study?
This clinical trial studies the following conditions: Lymphoblastic Leukemia, Acute, Childhood, Leukemia, Acute Lymphoblastic.
Who is sponsoring clinical trial NCT05440409?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05440409 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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