RDC-Blinatumomab Versus hyperCVAD for Ph-negative B-ALL.
- Conditions
- Philadelphia-Negative ALLALL, Adult
- Interventions
- Registration Number
- NCT06250959
- Lead Sponsor
- Chen Suning
- Brief 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.
- Detailed 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 & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 124
- 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.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Reduced-dose Chemotherapy Followed by Blinatumomab Blinatumomab Injection [Blincyto] 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. hyperCVAD Doxorubicin 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
- Primary Outcome Measures
Name Time Method Composite complete remission rate Induction therapy phase: The time of bone marrow evaluation is day 28±7. CR/CRi
- Secondary Outcome Measures
Name Time Method Treatment-related AE Induction therapy phase Incidence of treatment-related adverse events, including severe bleeding, infection, drug-related adverse events, and organ dysfunction.
Progression-free survival（PFS） 1 year after study completion The time from random assignment in a clinical trial to disease progression or death from any cause.
The negative rate of minimal residual lesion (MRD) Induction therapy phase: The time of bone marrow evaluation is day 28 ±7. The negative rate of minimal residual lesion (MRD) during induction therapy (The threshold is 1×10\^-4)
Quality of survival of patients in the induction therapy phase Induction therapy phase QLQ-C30 Survival Quality Scale
Overall survival (OS) 1 year after study completion From the time of enrollment in the study to the time of death from any cause.
Trial Locations
- Locations (1)
The First Affiliated Hospital of Soochow University
🇨🇳Suzhou, Jiangsu, China