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Tests treatment safety and results for Leukemia
Official title Effectiveness and Safety of Blinatumomab and Donor Lymphocyte Infusion in Maintenance Therapy After Allogeneic Hematopoietic Stem Cell Transplantation for High-risk Ph Negative B Cell Acute Lymphoblastic Leukemia
ClinicalTrials.gov ID: NCT07105579
What this study is testing
What is BITE and DLI?
BITE and DLI is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for 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
- A single-arm trial to evaluate the effectiveness and safety of Blinatumomab and Donor Lymphocyte Infusion in maintenance therapy after allogeneic hematopoietic stem cell transplantation for high-risk Ph negative B cell acute lymphoblastic leukemia
- 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 14 to 65
You may be able to join if
- Age 14-65 years (inclusive), regardless of gender.
- Newly diagnosed B-ALL with CD19 expression on leukemic cells (regardless of CD19 positivity rate).
- Ph-negative B-ALL with high-risk features post-allo-HSCT .
- ≥2 months post-transplant with hematopoietic reconstitution.
- Bone marrow morphology in remission and MRD-negative before enrollment.
You likely can't join if
- History of hypersensitivity or severe adverse reactions to the study drug or structurally similar compounds, as assessed by the investigator to...
- Pregnant or lactating women, or women of childbearing potential unwilling to use effective contraception.
- Severe cardiac dysfunction, including:Left ventricular ejection fraction (EF) \ 450 ms; women \>470 ms).Myocardial infarction within the past...
- Severe pulmonary dysfunction (obstructive and/or restrictive ventilatory impairment).
- Severe hepatic impairment:ALT or total bilirubin (TBIL) \>3× upper limit of normal (ULN).
- Severe renal impairment:Serum creatinine (Cr) \>2× ULN.24-hour creatinine clearance (Ccr) \<50 mL/min.
See the full eligibility criteria
- Age 14-65 years (inclusive), regardless of gender.
- Newly diagnosed B-ALL with CD19 expression on leukemic cells (regardless of CD19 positivity rate).
- Ph-negative B-ALL with high-risk features post-allo-HSCT .
- ≥2 months post-transplant with hematopoietic reconstitution.
- Bone marrow morphology in remission and MRD-negative before enrollment.
- ECOG performance status \<3 and Karnofsky score ≥70.
- No history of grade III/IV graft-versus-host disease (GVHD) and no active GVHD at enrollment.
- Adequate organ function:AST and ALT ≤3× upper limit of normal (ULN), total bilirubin ≤2×ULN.Serum creatinine ≤2×ULN or creatinine clearance ≥50 mL/min (calculated by Cockcroft-Gault formula).Left ventricular ejection...
- Expected survival \>3 months.
- Voluntary provision of written informed consent, with ability to understand and comply with study requirements.
- History of hypersensitivity or severe adverse reactions to the study drug or structurally similar compounds, as assessed by the investigator to preclude participation.
- Pregnant or lactating women, or women of childbearing potential unwilling to use effective contraception.
- Severe cardiac dysfunction, including:Left ventricular ejection fraction (EF) \ 450 ms; women \>470 ms).Myocardial infarction within the past year.Symptomatic coronary artery disease requiring medication.
- Severe pulmonary dysfunction (obstructive and/or restrictive ventilatory impairment).
- Severe hepatic impairment:ALT or total bilirubin (TBIL) \>3× upper limit of normal (ULN).
- Severe renal impairment:Serum creatinine (Cr) \>2× ULN.24-hour creatinine clearance (Ccr) \<50 mL/min.
- Active infection or uncontrolled bleeding, as assessed by the investigator to preclude safe administration of the study drug.
- History of thrombosis, embolism, cerebral hemorrhage, or other significant vascular events within the past year.
- Psychiatric disorders or other conditions that impair the ability to provide informed consent or comply with study procedures.
- Major organ surgery within the past six weeks.
- Drug abuse or chronic alcoholism that may interfere with study assessments.
- Prior organ transplantation (excluding hematopoietic stem cell transplantation).
- Other conditions deemed by the investigator to make the patient unsuitable for participation.
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, 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, 14 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, 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.