Reduced-dose Chemotherapy Followed by Blinatumomab in Induction Therapy of Newly Diagnosed Non-elderly Ph-B-ALL

Chen Suning

Status and phase: Completed; Phase 2

Conditions: B Acute Lymphoblastic Leukemia

Treatments: Drug: Blinatumomab

Study type: Interventional

Funder types: Other

Identifiers

NCT05557110

SZ-ALL02

Details and patient eligibility

About

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.

Enrollment: 35 patients

Sex: All

Ages: 15 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 15-65
2. Ph-(BCR-ABL1 negative)B-ALL was diagnosed according to WHO diagnostic criteria
3. Newly diagnosed patients without prior induction therapy (except hydroxyurea and glucocorticoids ≦5 days)
4. ECOG score 0-3
5. 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)
6. Renal function: endogenous creatinine clearance ≧30ml/min
7. Patients must be able to understand and willing to participate in the study and must sign the informed consent form.

Exclusion criteria

1. Ph+ (BCR-ABL1 positive) ALL and known ABL class Ph-Like ALL
2. T cells ALL
3. Mature B-cell leukemia/lymphoma, B-cell lymphoma, isolated extramedullary disease
4. Acute mixed-cell leukemia
5. Central nervous system leukemia
6. HIV infection
7. HBV-DNA or HCV-RNA positive
8. Patients with grade 2 or higher heart failure and other patients deemed inappropriate for inclusion by the investigator
9. Pregnant or breastfeeding patients
10. The study patient was refused enrollment

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

reduced-intensity chemotherapy followed by berintuzumab

Experimental group

Description:

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.

Treatment:

Drug: Blinatumomab