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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06250959
Other study ID # BEAT-ALL-2024
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date February 5, 2024
Est. completion date December 31, 2026

Study information

Verified date April 2024
Source The First Affiliated Hospital of Soochow University
Contact Jing Lu
Phone 1377183627
Email lujing@suda.edu.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In this study, newly diagnosed non-elderly patients with Philadelphia chromosomal negative (PH-) B-ALL were enrolled and 1:1 randomised into Reduced-intensity chemotherapy followed by Blinatumomab cohort or hyperCVAD cohort as induction therapy. The clinical remission rate, MRD negative rate and treaty-related adverse reactions were evaluated.


Description:

Blinatumomab, a CD3/CD19 bisespecific T-cell conjugative antibody, has shown high efficacy in phase I/II studies of relapsed/refractory B-lymphoblastic leukemia (B-ALL), particularly in the context of low tumor burden.Meanwhile, Blinatumomab also plays an important role in rapid and efficient clearance of MRD in patients. Therefore, its use in combination with less intensive chemotherapy for initial induction therapy in newly diagnosed patients may result in favorable response rates, greater depth of remission, and lower treatment-related toxic effects. In this study, newly diagnosed non-elderly patients with Philadelphia chromosomal negative (PH-) B-ALL were enrolled and 1:1 randomised into Reduced-intensity chemotherapy followed by Blinatumomab cohort or hyperCVAD cohort as induction therapy. The clinical remission rate, MRD negative rate and treaty-related adverse reactions were evaluated. The regimen of consolidation therapy is recommended as multidrug combination chemotherapy (including high-dose Methotrexate or Cytarabine combined with Asparaginase) or alternating with Blinatumomab (28 ug/d×28d). If Allogeneic Hematopoietic Stem Cell Transplantation (Allo-HSCT) is not performed, consolidation therapy needs at least 4 courses before 2 years maintenance therapy.


Recruitment information / eligibility

Status Recruiting
Enrollment 124
Est. completion date December 31, 2026
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 15 Years to 65 Years
Eligibility Inclusion Criteria: - Age 15-65 - Ph-(BCR-ABL1 negative)B-ALL was diagnosed according to WHO diagnostic criteria - Newly diagnosed patients without prior induction therapy (except hydroxyurea and glucocorticoids ?5 days - ECOG score 0-3 - Liver function: total bilirubin ? 3 times the upper limit of normal; Alanine ·aminotransferase ? 3 times upper limit of normal motion; Aspartate aminotransferase ? 3 times upper limit of normal motion; (except considering leukemia infiltration) - Renal function: endogenous creatinine clearance ?30ml/min - Patients must be able to understand and willing to participate in the study and must sign the informed consent form. Exclusion Criteria: - Ph+ (BCR-ABL1 positive) ALL - T cells ALL - Mature B-cell leukemia/lymphoma, B-cell lymphoma, with extramedullary disease - Acute mixed-cell leukemia - Central nervous system leukemia - HIV infection - HBV-DNA or HCV-RNA positive - Patients with grade 2 or higher heart failure and other patients deemed inappropriate for inclusion by the investigator - Pregnant or breastfeeding patients - The study patient was refused enrollment

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Blinatumomab Injection [Blincyto]
Reduced-intensity chemotherapy followed by Blinatumomab
Doxorubicin
HyperCVAD regimen

Locations

Country Name City State
China The First Affiliated Hospital of Soochow University Suzhou Jiangsu

Sponsors (1)

Lead Sponsor Collaborator
Chen Suning

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Composite complete remission rate CR/CRi Induction therapy phase: The time of bone marrow evaluation is day 28±7.
Secondary The negative rate of minimal residual lesion (MRD) The negative rate of minimal residual lesion (MRD) during induction therapy (The threshold is 1×10^-4) Induction therapy phase: The time of bone marrow evaluation is day 28 ±7.
Secondary Treatment-related AE Incidence of treatment-related adverse events, including severe bleeding, infection, drug-related adverse events, and organ dysfunction. Induction therapy phase
Secondary Quality of survival of patients in the induction therapy phase QLQ-C30 Survival Quality Scale Induction therapy phase
Secondary Progression-free survival(PFS) The time from random assignment in a clinical trial to disease progression or death from any cause. 1 year after study completion
Secondary Overall survival (OS) From the time of enrollment in the study to the time of death from any cause. 1 year after study completion
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