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NCT06144606 · ClinicalTrials.gov registry record · Phase 2
Study of KTE-X19 in Minimal Residual Disease (MRD) Positive B-Cell Acute Lymphoblastic Leukemia (B-ALL)
A Phase 2 study of Acute Lymphoblastic Leukemia and B-Cell Lymphoblastic Leukemia, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT06144606: Recruiting Phase 2 study of Acute Lymphoblastic Leukemia and B-Cell Lymphoblastic Leukemia, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT06144606 is a Phase 2 study of Acute Lymphoblastic Leukemia and B-Cell Lymphoblastic Leukemia that is actively recruiting participants, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 60 participants, below the 382-participant average among 131 other Acute Lymphoblastic Leukemia trials with a reported enrollment target (84% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06144606, a Phase 2 study of Acute Lymphoblastic Leukemia and B-Cell Lymphoblastic Leukemia, is actively recruiting participants, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a Phase 2 Study is to determine the efficacy and safety rate of B-Cell Acute Lymphoblastic Leukemia (B-ALL) participants in remission with minimal residual disease (MRD) after KTE-X19 CAR T-cell therapy
Primary Outcome
The primary endpoint is RFS, defined as the time from KTE-X19 infusion until clinical relapse or death from any cause. Patients proceeding to subsequent anti-cancer therapy, inclusive of allogeneic transplantation, without relapse will be censored in this analysis. Surviving patients not meeting criteria for relapse by the analysis data cutoff date will be censored at their last evaluable disease assessment date.
Conditions Studied
Interventions
- DRUG Tecartus
Study Locations (1)
Florida
- Moffitt Cancer Center - Tampa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2023-12-26 |
| Est. Completion | 2028-11-15 |
| Phase | Phase 2 |
What NCT06144606 shows while recruiting
NCT06144606 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 382-participant average among 131 other Acute Lymphoblastic Leukemia trials with a reported enrollment target (84% lower).
The record links to 2 conditions, with Acute Lymphoblastic Leukemia appearing as the primary indexed condition, and to 1 intervention - of which Tecartus is the first listed.
NCT06144606 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT06144606 about?
NCT06144606 is a clinical study titled "Study of KTE-X19 in Minimal Residual Disease (MRD) Positive B-Cell Acute Lymphoblastic Leukemia (B-ALL)". This is a Phase 2 Study is to determine the efficacy and safety rate of B-Cell Acute Lymphoblastic Leukemia (B-ALL) participants in remission with minimal residual disease (MRD) after KTE-X19 CAR T-cell therapy
What is the current status of trial NCT06144606?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2023-12-26. Estimated completion is 2028-11-15.
What conditions does trial NCT06144606 study?
This clinical trial studies the following conditions: Acute Lymphoblastic Leukemia, B-Cell Lymphoblastic Leukemia.
What interventions are being tested in trial NCT06144606?
The interventions under investigation include: Tecartus (DRUG).
Who is sponsoring clinical trial NCT06144606?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06144606 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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.
Where NCT06144606's enrollment target sits among peer trials
60 64th of 131 higher than 65 of 131 other Acute Lymphoblastic Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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