A Multicenter, Single-arm, Open-end Study of Reduced-dose Chemotherapy Followed by Blinatumomab in Induction Therapy of Newly Diagnosed Non-elderly Philadelphia Chromosome Negative Acute B Lymphoblastic Leukemia
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- Overall response rate (ORR)
Study Overview
Brief Summary
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 treated with reduced-intensity chemotherapy followed by Blinatumomab as the basis of induction therapy. The clinical remission rate, MRD negative rate and treaty-related adverse reactions were evaluated in newly diagnosed non-elderly PH-B-ALL patients during induction therapy.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 15 Years to 65 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 and known ABL class Ph-Like ALL
- •T cells ALL
- •Mature B-cell leukemia/lymphoma, B-cell lymphoma, isolated 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
Arms & Interventions
reduced-intensity chemotherapy followed by berintuzumab
Induction therapy was performed with reduced intensity chemotherapy (including 1 dose of Idarubicin 8 mg/m2, 1 dose of Vindesine 3 mg/m2, 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. Bone marrow evaluation was performed on day 22±2, and consolidation therapy was performed after achieving bone marrow remission (CR/CRh/CRi). If CR/CRh/CRi was not achieved in the first course of induction therapy, Blinatumomab (28ug/d×14d) should be continued and bone marrow evaluation should be evaluated again.
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.
Intervention: Blinatumomab (Drug)
Outcomes
Primary Outcomes
Overall response rate (ORR)
Time Frame: Induction therapy phase: The time of bone marrow evaluation is day 22 or 37±2.
Overall response rate (ORR), including complete response (CR)/ complete response rate with partial hematologic recovery (CRh)/ complete response rate with incomplete hematologic recovery (CRi).
Secondary Outcomes
- Event-free survival (EFS)(1 year after study completion)
- Overall survival (OS)(1 year after study completion)
- The negative rate of minimal residual lesion (MRD)(Induction therapy phase: The time of bone marrow evaluation is day 22 or 37±2.)
- Time of hematopoietic recovery(From the beginning of induction therapy to the beginning of consolidation therapy.)
- Treatment-related SAE(From the beginning of induction therapy to the beginning of consolidation therapy.)
Investigators
Chen Suning
Physician
The First Affiliated Hospital of Soochow University