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

NCT05557110 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: SZ-ALL02
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

B Acute Lymphoblastic Leukemia

Keywords

Blinatumomab; Ph-B-ALL; Induction therapy

Outcome Measures

Primary Outcomes (1)

• Overall response rate (ORR)

  Overall response rate (ORR), including complete response (CR)/ complete response rate with partial hematologic recovery (CRh)/ complete response rate with incomplete hematologic recovery (CRi).

  Induction therapy phase: The time of bone marrow evaluation is day 22 or 37±2.

Secondary Outcomes (5)

• The negative rate of minimal residual lesion (MRD)

  Induction therapy phase: The time of bone marrow evaluation is day 22 or 37±2.

• Treatment-related SAE

  From the beginning of induction therapy to the beginning of consolidation therapy.

• Time of hematopoietic recovery

  From the beginning of induction therapy to the beginning of consolidation therapy.

• Event-free survival (EFS)

  1 year after study completion

• Overall survival (OS)

  1 year after study completion

Study Arms (1)

reduced-intensity chemotherapy followed by berintuzumab

EXPERIMENTAL

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.

Drug: Blinatumomab

Interventions

Blinatumomab DRUG

Reduced-intensity chemotherapy followed by Blinatumomab

reduced-intensity chemotherapy followed by berintuzumab

Eligibility Criteria

• Age: 15 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 15-65
• 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.

You may not qualify if:

• 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
• Pregnant or breastfeeding patients
• The study patient was refused enrollment

Sponsors & Collaborators

• Chen Suning: lead

Study Sites (1)

The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology

Suzhou, Jiangsu, 215000, China

Location

Related Publications (2)

• 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.

  PMID: 39218935 RESULT

• Lu J, Zhu Y, Qiu H, Wang Y, Zhou X, Dai H, Lu 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, Yang X, Chen S. Reduced-dose chemotherapy followed by blinatumomab for newly diagnosed philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia: a propensity-matched comparison with hyper-CVAD. Discov Oncol. 2025 Feb 21;16(1):223. doi: 10.1007/s12672-025-01968-8.

  PMID: 39984805 DERIVED

Related Links

• 2024EHA; P409

MeSH Terms

Conditions

Burkitt Lymphoma

Interventions

blinatumomab

Condition Hierarchy (Ancestors)

Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Suning Chen, PHD

  The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: September 16, 2022
• First Posted: September 27, 2022
• Study Start: September 8, 2022
• Primary Completion: January 5, 2024
• Study Completion: March 31, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)