Clinical trial NCT05557110: Reduced-dose Chemotherapy Followed by Blinatumomab in Induction Therapy of Newly Diagnosed Non-elderly Ph-B-ALL
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: B Acute Lymphoblastic Leukemia
Keywords: Blinatumomab
Ph-B-ALL
Induction therapy
Lead sponsor: The First Affiliated Hospital of Soochow University
Sponsor class: OTHER
First posted: 2022-09-27
Enrollment: 35
Sex: ALL
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Overall response rate (ORR)
timeFrame: Induction therapy phase: The time of bone marrow evaluation is day 22 or 37±2.
Secondary outcomes:
measure: The negative rate of minimal residual lesion (MRD)
timeFrame: Induction therapy phase: The time of bone marrow evaluation is day 22 or 37±2.
measure: Treatment-related SAE
timeFrame: From the beginning of induction therapy to the beginning of consolidation therapy.
measure: Time of hematopoietic recovery
timeFrame: From the beginning of induction therapy to the beginning of consolidation therapy.
measure: Event-free survival (EFS)
timeFrame: 1 year after study completion
measure: Overall survival (OS)
timeFrame: 1 year after study completion
Other outcomes:
Locations:
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology
name: Suning Chen, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lu J, Qiu H, Wang Y, Zhou X, Dai H, Lu X, Yang X, Gu B, Hong M, Miao M, Lu R, Wang J, Wu Q, Xue M, Wang Y, Deng A, Shen Y, Liu Y, Dou X, Lei Y, Wu D, Zhu Y, Chen S. Reduced-dose chemotherapy and blinatumomab as induction treatment for newly diagnosed Ph-negative B-cell precursor acute lymphoblastic leukemia: a phase 2 trial. J Hematol Oncol. 2024 Sep 2;17(1):79. doi: 10.1186/s13045-024-01597-8.