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

ALL, Adult Clinical Trial

— BEAT-ALL-2024  

Official title:

Comparing the Efficacy and Safety of Reduced-dose Chemotherapy Followed by Blinatumomab Versus hyperCVAD as Induction Therapy for Newly Diagnosed Ph-negative B-ALL: a Multicenter, Radomized, Phase 2 Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06250959
• Other study ID #: BEAT-ALL-2024
• Status: Recruiting
• Phase: Phase 2
• Start date: February 5, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: April 2024
• Source: The First Affiliated Hospital of Soochow University
• Contact: Jing Lu
• Phone: 1377183627
• Email: lujing[@]suda.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 124
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• ALL, Adult
• Philadelphia-Negative ALL

Intervention

Drug:
• Blinatumomab Injection [Blincyto]
Reduced-intensity chemotherapy followed by Blinatumomab
• Doxorubicin
HyperCVAD regimen

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Soochow University	Suzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Chen Suning

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite complete remission rate	CR/CRi	Induction therapy phase: The time of bone marrow evaluation is day 28±7.
Secondary	The negative rate of minimal residual lesion (MRD)	The negative rate of minimal residual lesion (MRD) during induction therapy (The threshold is 1×10^-4)	Induction therapy phase: The time of bone marrow evaluation is day 28 ±7.
Secondary	Treatment-related AE	Incidence of treatment-related adverse events, including severe bleeding, infection, drug-related adverse events, and organ dysfunction.	Induction therapy phase
Secondary	Quality of survival of patients in the induction therapy phase	QLQ-C30 Survival Quality Scale	Induction therapy phase
Secondary	Progression-free survival(PFS)	The time from random assignment in a clinical trial to disease progression or death from any cause.	1 year after study completion
Secondary	Overall survival (OS)	From the time of enrollment in the study to the time of death from any cause.	1 year after study completion