Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed study of Lymphoblastic Leukemia, Acute, Childhood and Leukemia, Acute Lymphoblastic, sponsored by National Cancer Institute (NCI).
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
To evaluate the RFS at 6 months following CD19 CAR stratified by prior blinatumomab vs no prior blinatumomab.
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 |
What the finished NCT05440409 record still lists
NCT05440409 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 57 participants, a relatively small participant target, above the 32-participant average among 4 other Lymphoblastic Leukemia, Acute, Childhood trials with a reported enrollment target (78% higher).
The record links to 2 conditions, with Lymphoblastic Leukemia, Acute, Childhood appearing as the primary indexed condition, and to 0 interventions.
NCT05440409 reports a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Lymphoblastic Leukemia, Acute, Childhood
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
PO Ixazomib in Combination With Chemotherapy for Childhood Relapsed or Refractory Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma
ACTIVE NOT RECRUITING · Phase 1
-
Study of the Tocilizumab Optimization Timing for CART19 Associated Cytokine Release Syndrome
COMPLETED · Phase 1
-
A Safety and Tolerability Study of Clofarabine, Etoposide, Cyclophosphamide, PEG-asparaginase, and Vincristine in Pediatric Acute Lymphoblastic Leukemia (ALL)
COMPLETED · Phase 1
-
A Phase I Study of 5-Azacytidine in Combination With Chemotherapy for Children With Relapsed or Refractory ALL or AML
COMPLETED · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03521830 · 57 participants · Phase 2
Nivolumab Alone or Plus Relatlimab or Ipilimumab for Patients With Locally-Advanced Unresectable or Metastatic Basal Cell Carcinoma
- NCT03587701 · 57 participants · Phase 2
Effects of Anakinra in Subjects With Corticosteroid-resistant/Intolerant Meniere's Disease and Autoimmune Inner Ear Disease
- NCT04104126 · 57 participants · NA
Blood Flow Restriction Therapy in Achilles Injury
- NCT04703842 · 57 participants · Phase 1
Modulation of SERCA2a of Intra-myocytic Calcium Trafficking in Heart Failure With Reduced Ejection Fraction
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI