BridgeMD
Compares treatment options for B ALL
Official title CD19 CAR-T vs DLI for Post-HSCT MRD in Ph- ALL: A RCT
ClinicalTrials.gov ID: NCT07441291
What this study is testing
What is CAR-T?
CAR-T is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for b all.
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
- This prospective, open-label randomized controlled trial compares CD19 CAR-T therapy with chemotherapy plus donor lymphocyte infusion (DLI) in 70 patients with Ph-negative B-cell acute lymphoblastic leukemia (B-ALL) who exhibited minimal residual disease (MRD) positivity (≥0.1% CD19+ abnormal B cells) after allogeneic hematopoietic stem cell transplantation (HSCT). Patients (aged 3-\<80 years, ECOG 0-2, no relapse, adequate organ function) were randomized to receive either autologous CD19 CAR-T cells following lymphodepletion or conventional chemotherapy with DLI.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 3 to 79
You may be able to join if
- age 3-\<80 years
- ECOG performance status 0-2
- post-HSCT MRD positivity (≥0.1% CD19+ abnormal B cells by flow cytometry)
- no hematological/extramedullary relapse
- adequate organ function
You likely can't join if
- active infections
- uncontrolled graft-versus-host disease (GVHD)
- history of central nervous system disorders
- autoimmune diseases
- other active malignancies
See the full eligibility criteria
- age 3-\<80 years
- ECOG performance status 0-2
- post-HSCT MRD positivity (≥0.1% CD19+ abnormal B cells by flow cytometry)
- no hematological/extramedullary relapse
- adequate organ function
- negative pregnancy test (for fertile females)
- active infections
- uncontrolled graft-versus-host disease (GVHD)
- history of central nervous system disorders
- autoimmune diseases
- other active malignancies
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China, China
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 - 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, 3 years to 79 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.