Trial studying safety and effects for Relapsed/Refractory
Official title 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 ID: NCT06287229
What this study is testing
What is Blinatumomab?
Blinatumomab is an investigational medicine, given as a monthly IV infusion (through a vein), being studied as a potential treatment for relapsed/refractory.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to learn how safe brexucabtagene autoleucel is and whether it can help control B‑cell ALL after patients have received inotuzumab ozogamicin, blinatumomab, and either hyper‑CVAD or mini‑hyper‑CVAD.
- Who it's for
- It looks for adults with relapsed or refractory B‑cell ALL, or newly diagnosed high‑risk B‑cell ALL, who have already undergone the specified chemotherapy regimens.
- What's involved
- Participants will receive brexucabtagene autoleucel and will attend scheduled clinic visits and medical tests to monitor safety and disease status.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants of age ≥18 years with documented relapsed or refractory B-cell ALL
- KMT2A rearranged ALL
- Complex cytogenetics as per NCCN 2022
- Low-hypodiploidy/tetraploidy
- Philadelphia-like ALL (based on CRLF2 overexpression or recurrent Ph-like genetic fusions)
You likely can't join if
- Philadelphia positive B-cell ALL
- Pregnant or lactating; women of child-bearing potential (WOCBP) must have negative pregnancy test.
- Prior exposure to brexu-cel or other anti-CD-19 CAR T cell therapy
- Active and uncontrolled disease/infection as judged by the treating physician
- Unable or unwilling to sign the consent form
- No other investigational therapy within the past 14 days
See the full eligibility criteria
- Participants of age ≥18 years with documented relapsed or refractory B-cell ALL
- KMT2A rearranged ALL
- Complex cytogenetics as per NCCN 2022
- Low-hypodiploidy/tetraploidy
- Philadelphia-like ALL (based on CRLF2 overexpression or recurrent Ph-like genetic fusions)
- Performance status of 0, 1, or 2
- Adequate organ function with creatinine less than or equal to 1.6 mg/dl, bilirubin less than or equal to 3.5 mg and ALT and AST less than or equal to 5 times institutional upper limit of normal
- Participants should be CD19 expression positive (\>50%) before enrollment
- Participants with chronic viral infections like Hepatitis B-virus, Hepatitis C virus or Human Immunodeficiency virus I/II will be eligible if they are on therapy and infections are under control.
- Philadelphia positive B-cell ALL
- Pregnant or lactating; women of child-bearing potential (WOCBP) must have negative pregnancy test. WOCBP defined as not post-menopausal for 12 months or no previous surgical sterilization
- Prior exposure to brexu-cel or other anti-CD-19 CAR T cell therapy
- Active and uncontrolled disease/infection as judged by the treating physician
- Unable or unwilling to sign the consent form
- No other investigational therapy within the past 14 days
The study team makes the final eligibility decision.
Where it is enrolling
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Houston, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.