Immunotherapy in B-Cell Acute Lymphoblastic Leukemia.
Kara L Davis, Catherine C Yao, Jessica A O Zimmerman...
https://pubmed.ncbi.nlm.nih.gov/41671463Actively Recruiting
Phase 1
Age: 15Years - 65Years
All Genders
ID06507514
Safety and Efficacy of Blinatumomab and Autologous HSCT Sandwich Strategy as Consolidation Therapy for B-cell Acute Lymphoblastic Leukemia
Led by The First Affiliated Hospital of Soochow University · Updated on 2025-11-21
4
Participants Needed
1
Research Sites
104 weeks
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating a new treatment approach for adults with B-cell Acute Lymphoblastic Leukemia (B-ALL) who may not have a suitable donor for allogeneic stem cell transplantation or refuse it. The study focuses on using a combination of blinatumomab, a medication known to clear minimal residual disease (MRD), and autologous hematopoietic stem cell transplantation (auto-HSCT). This "sandwich" strategy aims to reduce relapse rates and improve leukemia-free survival and overall survival, while addressing treatment-related mortality concerns seen in traditional methods. Participants first receive induction chemotherapy followed by two cycles of consolidation chemotherapy, including high-dose cytarabine plus pegaspargase, with or without tyrosine kinase inhibitors, and methotrexate plus pegaspargase, again with or without tyrosine kinase inhibitors. After this, they are treated sequentially with blinatumomab. Stem cell mobilization and collection occur 6 to 8 weeks after the first blinatumomab infusion, followed by autologous stem cell transplantation. Starting three months post-transplant, participants receive maintenance treatment with blinatumomab every three months for four cycles. A long-term follow-up period of two years is conducted to monitor outcomes. During the study, participants undergo regular monitoring of minimal residual disease using flow cytometry and gene sequencing. Safety and efficacy are assessed by tracking leukemia-free survival, overall survival, and adverse events over four years. Various laboratory tests and heart and lung function assessments are used to ensure participant safety. The study spans from treatment through a two-year follow-up, with data collected on survival rates and treatment-related mortality to understand the impact of this new consolidation therapy strategy.
CONDITIONS
Brief Title
Blinatumomab and Auto-HSCT Sandwich Strategy as Consolidation Therapy for B-ALL
Who Can Participate
Age: 15Years - 65Years
All Genders
Eligibility Criteria
You may qualify if you...
- Diagnosed with B-cell Acute Lymphoblastic Leukemia (B-ALL) and either have no suitable allogeneic HSCT donor or refuse allogeneic HSCT
- Positive CD19 expression detected in peripheral blood or bone marrow cells
- Cardiac ultrasound showing left ventricular ejection fraction of at least 50%
- Creatinine level less than or equal to 1.6 mg/dl
- Liver enzymes (ALT and AST) less than or equal to 3 times the normal range
- Total bilirubin less than or equal to 2.0 mg/dl
- Pulmonary function with grade 1 or less dyspnea and oxygen saturation above 91% without oxygen support
- Aged between 15 and 65 years, inclusive
- Passed T-cell amplification test
- Expected survival longer than 3 months
You will not qualify if you...
- Recurrence limited to isolated extramedullary lesions or having other malignant tumors
- Previous treatment with anti-CD19 therapies
- Use of immunosuppressants within 2 weeks before or planned use after consent
- Uncontrolled active infections
- HIV infection
- Active hepatitis B or C infection
- History of severe allergic reactions to aminoglycoside antibiotics
- History or presence of serious central nervous system diseases such as epilepsy, stroke, dementia, or psychosis
AI-Screening
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Several months including induction, consolidation, transplantation, and maintenance phases
Participants receive induction chemotherapy and two cycles of consolidation chemotherapy, followed by sequential blinatumomab infusion. After the first blinatumomab treatment, autologous stem cell mobilization, collection, and transplantation are performed. Starting three months after transplantation, participants receive maintenance treatment with blinatumomab every three months for four cycles.
Multiple visits including chemotherapy administration, stem cell collection, transplantation, and maintenance cycles every three months
Follow-up
Duration - 2 years
Participants are monitored long-term for safety and efficacy outcomes including leukemia-free survival and overall survival over a two-year period.
Regular follow-up visits during the 2-year monitoring period
Trial Site Locations
Total: 1 location
1
The First Affliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215006
Actively Recruiting
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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