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NCT06287229 · ClinicalTrials.gov registry record · Phase 1
Phase Ib/II Study Assessing the Clinical Activity and Safety of Brexucabtagene Autoleucel as a Consolidation in Patients With Relapsed/Refractory (R/R) and Newly Diagnosed B-cell Acute Lymphocytic Leukemia (ALL) Post Cytoreduction With Mini-HCVD-inotuzumab-blinatumomab/HCVAD-inotuzumab-blinatumomab
A Phase 1 study of Relapsed/Refractory and B-cell Acute Lymphocytic Leukemia, sponsored by M.D. Anderson Cancer Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT06287229: Recruiting Phase 1 study of Relapsed/Refractory and B-cell Acute Lymphocytic Leukemia, sponsored by M.D. Anderson Cancer Center.
NCT06287229 is a Phase 1 study of Relapsed/Refractory and B-cell Acute Lymphocytic Leukemia that is actively recruiting participants, run by M.D. Anderson Cancer Center. The registered enrollment target is 40 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06287229, a Phase 1 study of Relapsed/Refractory and B-cell Acute Lymphocytic Leukemia, is actively recruiting participants, sponsored by M.D. Anderson Cancer Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
To learn about the safety of giving the drug brexucabtagene autoleucel to participants with relapsed/refractory B-cell ALL after treatment with inotuzumab ozogamicin, blinatumomab, and either hyper-CVAD or mini-hyper-CVD. Also, to learn if giving brexucabtagene autoleucel to patients with relapsed/refractory or high-risk, newly diagnosed B-cell ALL after treatment with inotuzumab ozogamicin, blinatumomab, and either hyper-CVAD or mini-hyper-CVD can help to control the disease.
Primary Outcome
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Conditions Studied
Interventions
- DRUG Blinatumomab
- DRUG Inotuzumab Ozogamicin
- DRUG Hyper-CVAD
- DRUG Mini-hyper-CVD
Study Locations (1)
Texas
- MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2024-07-11 |
| Est. Completion | 2030-12-31 |
| Phase | Phase 1 |
What NCT06287229 shows while recruiting
NCT06287229 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower).
The record links to 2 conditions, with Relapsed/Refractory appearing as the primary indexed condition, and to 4 interventions - of which Blinatumomab is the first listed.
NCT06287229 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT06287229 about?
NCT06287229 is a clinical study titled "Phase Ib/II Study Assessing the Clinical Activity and Safety of Brexucabtagene Autoleucel as a Consolidation in Patients With Relapsed/Refractory (R/R) and Newly Diagnosed B-cell Acute Lymphocytic Leukemia (ALL) Post Cytoreduction With Mini-HCVD-inotuzumab-blinatumomab/HCVAD-inotuzumab-blinatumomab". To learn about the safety of giving the drug brexucabtagene autoleucel to participants with relapsed/refractory B-cell ALL after treatment with inotuzumab ozogamicin, blinatumomab, and either hyper-CVAD or mini-hyper-CVD. Also, to learn if giving brexucabtagene autoleucel to patients with relapsed/r...
What is the current status of trial NCT06287229?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2024-07-11. Estimated completion is 2030-12-31.
What conditions does trial NCT06287229 study?
This clinical trial studies the following conditions: Relapsed/Refractory, B-cell Acute Lymphocytic Leukemia.
What interventions are being tested in trial NCT06287229?
The interventions under investigation include: Blinatumomab (DRUG), Inotuzumab Ozogamicin (DRUG), Hyper-CVAD (DRUG), Mini-hyper-CVD (DRUG).
Who is sponsoring clinical trial NCT06287229?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06287229 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06287229's enrollment target sits among peer trials
40 1131st of 2000 higher than 810 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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