A Phase 2 interventional study of Blinatumomab Injection [Blincyto] and Doxorubicin in ALL, Adult and Philadelphia-Negative ALL, sponsored by Chen Suning. Recruiting at 1 site in China. Open to participants aged 15 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-04-04.
Sponsored by Chen Suning · Phase 2, Interventional, and Treatment
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.
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.
Chen Suning is the lead sponsor of 6 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Reduced-dose Chemotherapy(including 1 dose of Idarubicin 8 mg/m2, 1 dose of Vincristine 1.4 mg/m2\[max 2mg\], and 7 days of Dexamethasone 9 mg/m2/d) followed by 2 weeks of Blinatumomab (9 ug/d d8-14, 28 ug/d d15-21) immediately. If not achieved CR/CRi, Blinatumomab 28 ug for another 14 days should be continued.
Drug: Blinatumomab Injection [Blincyto]
CTX 300mg/m2 q12h D1-3 VCR 1.4mg/m2 (max 2mg) D4,D11 DNR 50mg/m2, D4 DEX 40mg/d D1-4, D11-14
Drug: Doxorubicin
Reduced-intensity chemotherapy followed by Blinatumomab
HyperCVAD regimen
Composite complete remission rate
CR/CRi
Time frame: Induction therapy phase: The time of bone marrow evaluation is day 28±7.
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)
Time frame: Induction therapy phase: The time of bone marrow evaluation is day 28 ±7.
Treatment-related AE
Incidence of treatment-related adverse events, including severe bleeding, infection, drug-related adverse events, and organ dysfunction.
Time frame: Induction therapy phase
Quality of survival of patients in the induction therapy phase
QLQ-C30 Survival Quality Scale
Time frame: Induction therapy phase
Progression-free survival（PFS）
The time from random assignment in a clinical trial to disease progression or death from any cause.
Time frame: 1 year after study completion
Overall survival (OS)
From the time of enrollment in the study to the time of death from any cause.
Time frame: 1 year after study completion
Plan to share: Yes — Study Protocol, Basic Statistical Analysis
Supporting information: Study protocol
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