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

NCT ID: NCT05557110

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-08
• Study Completion Date: 2024-03-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

reduced-intensity chemotherapy followed by berintuzumab

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.

Group Type: EXPERIMENTAL

Blinatumomab

Intervention Type: DRUG

Reduced-intensity chemotherapy followed by Blinatumomab

Interventions

Blinatumomab

Reduced-intensity chemotherapy followed by Blinatumomab

Intervention Type: DRUG

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chen Suning

OTHER

Sponsor Role: lead

Responsible Party

Chen Suning

Physician

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Suning Chen, PHD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Suzhou, Jiangsu, China

Countries

China

References

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.

Reference Type: RESULT

PMID: 39218935 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 39984805 (View on PubMed)

Related Links

http://library.ehaweb.org/eha/2024/eha2024-congress/420473/jing.lu.blinatumomab.induction.therapy.following.reduced-dose.chemotherapy.in.html?f=listing%3D4%2Abrowseby%3D8%2Asortby%3D2%2Amedia%3D3%2Aspeaker%3D1000669

2024EHA; P409

Other Identifiers

SZ-ALL02

Identifier Type: -

Identifier Source: org_study_id