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New treatment option for ALL (Acute B-Lymphoblastic Leukemia)
Official title Blinatumomab Combined With Low-dose DLI as Maintenance Therapy After Transplantation for B-ALL
ClinicalTrials.gov ID: NCT07677878
What this study is testing
What is Blinatumomab Injection?
Blinatumomab Injection is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for all (acute b-lymphoblastic leukemia).
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 study will be conducted in high-risk B-ALL patients post-allo-HSCT. We propose to investigate the safety and therapeutic efficacy of blinatumomab plus low-dose DLI maintenance therapy, with the ultimate goal of enhancing long-term survival outcomes.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 1) Voluntary participation: The participant or legal guardian fully understands this clinical study, provides informed consent (ICF), and is...
- \>CR1 status
- Pre-transplant MRD+ status
- Ph-like subtype
- KMT2A rearrangement
You likely can't join if
- 1) Drug hypersensitivity/contraindications: Patients with known allergies or contraindications to the investigational drug(s). 2)...
- Liver: ALT or AST \> 2.5 × ULN; Total bilirubin \> 2 × ULN
- Kidney: Serum creatinine \> ULN 8) Investigator judgment: Patients deemed ineligible by investigators (e.g., poor compliance, substance abuse).
See the full eligibility criteria
- 1) Voluntary participation: The participant or legal guardian fully understands this clinical study, provides informed consent (ICF), and is willing/able to comply with all trial procedures. 2) Age: \<70 years old at...
- \>CR1 status
- Pre-transplant MRD+ status
- Ph-like subtype
- KMT2A rearrangement
- Other high-risk cytogenetic/genetic factors per ELN 2023 criteria. 4) Allergy: No history of severe allergies. 5) Liver function: ALT and AST ≤ 2.5 × ULN; Total bilirubin ≤ 2 × ULN. 6) Renal function: Serum creatinine ≤...
- 1) Drug hypersensitivity/contraindications: Patients with known allergies or contraindications to the investigational drug(s). 2) Pregnancy/lactation: Pregnant or breastfeeding female patients. 3) Active infection/GVHD...
- Liver: ALT or AST \> 2.5 × ULN; Total bilirubin \> 2 × ULN
- Kidney: Serum creatinine \> ULN 8) Investigator judgment: Patients deemed ineligible by investigators (e.g., poor compliance, substance abuse).
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, 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, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, 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.