RDC-Blinatumomab Versus hyperCVAD for Ph-negative B-ALL.

NCT ID: NCT06250959

Last Updated: 2024-04-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-05
• Study Completion Date: 2026-12-31

Brief Summary

In this study, newly diagnosed non-elderly patients with Philadelphia chromosomal negative (PH-) B-ALL were enrolled and 1:1 randomised into Reduced-intensity chemotherapy followed by Blinatumomab cohort or hyperCVAD cohort as induction therapy. The clinical remission rate, MRD negative rate and treaty-related adverse reactions were evaluated.

Detailed Description

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 1:1 randomised into Reduced-intensity chemotherapy followed by Blinatumomab cohort or hyperCVAD cohort as induction therapy. The clinical remission rate, MRD negative rate and treaty-related adverse reactions were evaluated.

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.

Conditions

ALL, Adult; Philadelphia-Negative ALL

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Reduced-dose Chemotherapy Followed by Blinatumomab

Reduced-dose Chemotherapy(including 1 dose of Idarubicin 8 mg/m2, 1 dose of Vincristine 1.4 mg/m2\[max 2mg\], 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. If not achieved CR/CRi, Blinatumomab 28 ug for another 14 days should be continued.

Group Type: EXPERIMENTAL

Blinatumomab Injection [Blincyto]

Intervention Type: DRUG

Reduced-intensity chemotherapy followed by Blinatumomab

hyperCVAD

CTX 300mg/m2 q12h D1-3 VCR 1.4mg/m2 (max 2mg) D4,D11 DNR 50mg/m2, D4 DEX 40mg/d D1-4, D11-14

Group Type: ACTIVE_COMPARATOR

Doxorubicin

Intervention Type: DRUG

HyperCVAD regimen

Interventions

Blinatumomab Injection [Blincyto]

Reduced-intensity chemotherapy followed by Blinatumomab

Intervention Type: DRUG

Doxorubicin

HyperCVAD regimen

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• Ph+ (BCR-ABL1 positive) ALL
• T cells ALL
• Mature B-cell leukemia/lymphoma, B-cell lymphoma, with extramedullary disease
• Acute mixed-cell leukemia
• Central nervous system leukemia
• HIV infection
• HBV-DNA or HCV-RNA positive
• Patients with grade 2 or higher heart failure and other patients deemed inappropriate for inclusion by the investigator
• Pregnant or breastfeeding patients
• 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

Jing Lu, MD

Role: PRINCIPAL_INVESTIGATOR

Soochow U

Locations

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jing Lu

Role: CONTACT

lujing@suda.edu.cn

1377183627

Facility Contacts

Jing Lu

Role: primary

lujing@suda.edu.cn

1377183627

Other Identifiers

BEAT-ALL-2024

Identifier Type: -

Identifier Source: org_study_id