← Back to Search

Phase 1B + Phase 2 for Disease

Phase 1 & 2
Waitlist Available
Led By Elias Jabbour, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion; an average of 1 year
Awards & highlights

Study Summary

This trial will test the safety and effectiveness of giving the drug brexucabtagene autoleucel to participants with B-cell ALL who have not responded well to other treatments. The goal is

Who is the study for?
This trial is for patients with B-cell Acute Lymphocytic Leukemia (ALL) who have either not responded to previous treatments or are newly diagnosed and at high risk. Participants must have completed treatment with inotuzumab ozogamicin, blinatumomab, and hyper-CVAD or mini-hyper-CVD.Check my eligibility
What is being tested?
The study is testing the safety and effectiveness of brexucabtagene autoleucel as a follow-up therapy in controlling B-cell ALL after initial treatment with inotuzumab ozogamicin, blinatumomab, and hyper-CVAD/mini-hyper-CVD regimens.See study design
What are the potential side effects?
Potential side effects may include immune system reactions, infusion-related symptoms like fever or chills, fatigue, blood cell count changes leading to increased infection risk or bleeding problems. Each patient's experience may vary.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion; an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety and adverse events (AEs)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Phase 1B + Phase 2Experimental Treatment4 Interventions
Participants found to be eligible to take part in this study, you will be assigned to a study phase (Phase 1B or Phase 2). Up to 10 participants will be enrolled in Phase 1B, and up to 30 will be enrolled in Phase 2. All participants will first receive cytoreductive therapy (inotuzumab ozogamicin, blinatumomab, and either hyper-CVAD or mini-hyper-CVD), followed by lymphodepletion chemotherapy and 1 dose of brexucabtagene autoleucel.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hyper-CVAD
2010
Completed Early Phase 1
~10
Inotuzumab Ozogamicin
2011
Completed Phase 2
~360
Blinatumomab
2014
Completed Phase 3
~1210

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,976 Previous Clinical Trials
1,789,468 Total Patients Enrolled
3 Trials studying Disease
3,890 Patients Enrolled for Disease
Elias Jabbour, MDPrincipal InvestigatorM.D. Anderson Cancer Center
13 Previous Clinical Trials
1,190 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are potential participants currently able to apply for enrollment in this trial?

"As per clinicaltrials.gov, the trial is not presently seeking participants. The initial posting date was 8/31/2024 with the latest update on 2/29/2024. Although this specific study is closed for recruitment, there are currently 1474 other trials actively searching for eligible individuals to participate in medical research."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
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
2024. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06287229.
All > Acute Lymphocytic Leukemia
~27 spots leftby Dec 2028
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top