Overview

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

Status:
Recruiting

Trial end date:
2023-08-31

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

The First Affiliated Hospital of Soochow University

Treatments:

Blinatumomab

Criteria

Inclusion Criteria:

1. Age 15-59

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