A Phase 2 interventional study of Blinatumomab plus Reduced-dose Chemotherapy in Precursor B-Cell Acute Lymphoblastic Leukemia, sponsored by First Affiliated Hospital of Zhejiang University. Recruiting at 1 site in China. Open to participants aged 15 Years to 59 Years. Per ClinicalTrials.gov, last updated 2024-12-19.
Sponsored by First Affiliated Hospital of Zhejiang University · Phase 2, Interventional, and Treatment
Precursor B cell acute lymphoblastic leukemia (B-ALL) is an aggressive type of leukemia, with high relapse rate and poor long term survival in adults. Traditional treatment regimens mainly include chemotherapy and hematopoietic stem cell transplantation. In the past decade, with the application of molecular targeted drugs and immunotherapy, the survival of B-ALL patients has significantly improved. In this study，we propose a treatment approach that combines Blinatumomab and Reduced-dose Chemotherapy in B-ALL adults. Our study aims to answer the safety and efficacy of this treatment regimen, and further improve the survival for those participants.
This is a prospective, single-arm, phase II and open-label study. A total of 20 Ph-negative B-ALL participants will be enrolled. The primary endpoint is MRD-negative CR rate. The induction therapy is a combination of Blinatumomab(Blina), Vindesine(VDS), Cyclophosphamide(CTX) and Dexamethasone(DXM). The second cycle would be the combination of Blina and Venetoclax(VEN). As for consolidation therapy, we suggest the bone marrow transplantation. The purpose of this study is to explore the safety and efficacy of the treatment regimen in the treatment of newly diagnosed young Ph-negative B-ALL patients.
30 studies on the registry are indexed under Precursor B-Cell Lymphoblastic Leukemia-Lymphoma; 13 are open to participants now.
This study's planned enrollment of 20 is below the median of 50 across 28 interventional studies indexed under Precursor B-Cell Lymphoblastic Leukemia-Lymphoma.
Browse Precursor B-Cell Lymphoblastic Leukemia-Lymphoma studies →First Affiliated Hospital of Zhejiang University is the lead sponsor of 260 studies on the registry; 141 are open to participants now.
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Exclusion Criteria:
Blinatumomab plus Reduced-dose Chemotherapy
Drug: Blinatumomab plus Reduced-dose Chemotherapy
Cycle 1: Reduced VCP on day1, IV and Blinatumomab for 2 weeks, IV. Cycle 2: Blinatumomab for 2 weeks, IV and Venetoclax for 2 weeks, oral.
Complete remission rate with negative minimal residual disease
complete remission and negative MRD detected by flowcytometry
Time frame: at the end of cycle 1 and 2（each cycle is 28 days）
CR/CRi after Cycle 1 and 2
Blast rate lower than 5% with or without peripheral blood cell recovery
Time frame: at the end of cycle 1 and 2（each cycle is 28 days）
Minimal residual disease(MRD)
MRD level detected by flow cytometry which value \<0.1% is defined as negtive
Time frame: At the end of each cycle（each cycle is 28 days）
Overall survival (OS)
Defined for all patients in a trial; measured from day 1 of treatment to the date of death from any cause;
Time frame: up to 5 years
Event free survival(EFS)
Defined for all patients in a trial; measured from day 1 of treatment to the date of treatment failure, hematologic relapse from CR/CRi or death from any cause, whichever occurs first;
Time frame: up to 5 years
Minimal residual disease (MRD)
MRD level detected by next generation sequencing
Time frame: At the end of Cycle 1 and 2（each cycle is 28 days）
Plan to share: Yes — Open in the form of original data report before December 30, 2028
Supporting information: Clinical study report
Started Oct 2024 (actual). Primary completion is estimated for Oct 2026, 23 months after the start.
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Precursor B-Cell Lymphoblastic Leukemia-Lymphoma →
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