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NCT05460533 · ClinicalTrials.gov registry record · Phase 2
A Second Infusion (Early Reinfusion) of Tisagenlecleucel in Children and Young Adults With B-Cell Acute Lymphoblastic Leukemia(B-ALL)
A Phase 2 study of B-cell Acute Lymphoblastic Leukemia, sponsored by Memorial Sloan Kettering Cancer Center.
- Active
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
- 6
- Study locations
NCT05460533: Active Phase 2 study of B-cell Acute Lymphoblastic Leukemia, sponsored by Memorial Sloan Kettering Cancer Center.
NCT05460533 is a Phase 2 study of B-cell Acute Lymphoblastic Leukemia that is active but no longer recruiting, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 30 participants, below the 88-participant average among 21 other B-cell Acute Lymphoblastic Leukemia trials with a reported enrollment target (66% lower). The trial reports 6 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05460533, a Phase 2 study of B-cell Acute Lymphoblastic Leukemia, is active but no longer recruiting, sponsored by Memorial Sloan Kettering Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
- 6
- Study locations
Study Summary
The researchers are doing this study to see if early reinfusion of tisagenlecleucel can keep participants in B-CEll ApLasia at 6 months after their first infusion. The researchers will also look at the safety of early reinfusion and how effective it is at treating B-ALL.
Primary Outcome
below 10% (from 26% to 9%)
Conditions Studied
Interventions
- BIOLOGICAL Tisagenlecleucel
Study Locations (6)
California
- Children's Hospital of Los Angeles (Data Collection Only) - Los Angeles
- Stanford University (Data Collection Only) - Stanford
Colorado
- Children's Hospital Colorado (Data Collection Only) - Aurora
Maryland
- Johns Hopkins University (Data Collection Only) - Baltimore
New York
- Memorial Sloan Kettering Cancer Center - New York
Ohio
- Cincinnati Children's Hospital Medical Center (Data Collection Only) - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2022-07-12 |
| Est. Completion | 2027-07 |
| Phase | Phase 2 |
What the registry record for NCT05460533 still lists
NCT05460533 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 88-participant average among 21 other B-cell Acute Lymphoblastic Leukemia trials with a reported enrollment target (66% lower).
The record links to 1 condition, with B-cell Acute Lymphoblastic Leukemia appearing as the primary indexed condition, and to 1 intervention - of which Tisagenlecleucel is the first listed.
NCT05460533 lists 6 locations in 5 states (California, Colorado, Maryland).
Frequently Asked Questions
What is clinical trial NCT05460533 about?
NCT05460533 is a clinical study titled "A Second Infusion (Early Reinfusion) of Tisagenlecleucel in Children and Young Adults With B-Cell Acute Lymphoblastic Leukemia(B-ALL)". The researchers are doing this study to see if early reinfusion of tisagenlecleucel can keep participants in B-CEll ApLasia at 6 months after their first infusion. The researchers will also look at the safety of early reinfusion and how effective it is at treating B-ALL.
What is the current status of trial NCT05460533?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2022-07-12. Estimated completion is 2027-07.
What conditions does trial NCT05460533 study?
This clinical trial studies the following conditions: B-cell Acute Lymphoblastic Leukemia.
What interventions are being tested in trial NCT05460533?
The interventions under investigation include: Tisagenlecleucel (BIOLOGICAL).
Who is sponsoring clinical trial NCT05460533?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05460533 being conducted?
This trial has 6 study locations across California, Colorado, Maryland, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05460533's enrollment target sits among peer trials
30 19th of 21 higher than 3 of 21 other B-cell Acute Lymphoblastic Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other B-cell Acute Lymphoblastic Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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