B Acute Lymphoblastic Leukemia
Conditions
Keywords
Blinatumomab, Ph-B-ALL, Induction therapy
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.
Interventions
DRUGBlinatumomab
Reduced-intensity chemotherapy followed by Blinatumomab
Sponsors
Chen Suning
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall response rate (ORR) | 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
| Measure | Time frame | Description |
|---|---|---|
| The negative rate of minimal residual lesion (MRD) | Induction therapy phase: The time of bone marrow evaluation is day 22 or 37±2. | The negative rate of minimal residual lesion (MRD) during induction therapy (The threshold is 1×10\^-4) |
| Treatment-related SAE | From the beginning of induction therapy to the beginning of consolidation therapy. | Incidence of treatment-related severe adverse events, including severe bleeding, infection, drug-related adverse events, and organ dysfunction. |
| Time of hematopoietic recovery | From the beginning of induction therapy to the beginning of consolidation therapy. | The duration of the patient in the granulocytic deficiency and thrombocytopenia phases. |
| Event-free survival (EFS) | 1 year after study completion | The time from enrollment to the occurrence of any event, including death, progression of disease, change in treatment regimen, and occurrence of fatal or intolerable side effects. |
| Overall survival (OS) | 1 year after study completion | From the time of enrollment in the study to the time of death from any cause. |
Countries
China
Outcome results
None listed