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Efficacy and safety of one cycle Blinatumomab treatment in adult patients with MRD-positive or relapsed and refractory acute B acute lymphoblastic leukemia

Efficacy and safety of one cycle Blinatumomab treatment in adult patients with MRD-positive or relapsed and refractory acute B lymphoblastic leukemia: a single-arm, open-label, prospective clinical study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300072593
Enrollment
Unknown
Registered
2023-06-19
Start date
2023-06-19
Completion date
Unknown
Last updated
2023-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute B lymphoblastic leukemia (ALL)

Interventions

treatment:treatment with Blinatumomab

Sponsors

Shenzhen Second People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: ?Aged 18 to 65 years old, male or female; ?Patients with minimal residual disease (MRD) after induction or consolidation or intensive therapy, MRD monitoring was routinely performed by flow cytometry; If BCR::ABL fusion gene was positive, real-time quantitative PCR was used to detect MRD; clearly diagnosed relapsed or refractory according to Chinese guidelines for diagnosis and treatment of adult acute lymphoblastic leukemia (2021); ?Plan to receive allogeneic hematopoietic stem cell transplantation within 45 days; ?Voluntarily receive Blinatumomab treatment and paid for the drug; ?The physical state assessment (ECOG) score was 0-2; ?Patients provided written informed consent

Exclusion criteria

Exclusion criteria: ? Uncontrolled severe infection; ? known to be allergic to components of berintuzumab or its analogues; ? recurrent central nervous system leukemia; ? history of severe heart disease, severe liver and kidney dysfunction, and severe bleeding; ? unconscious or mentally ill or unable to operate with the diagnosis and treatment; ? pregnant or breastfeeding; ? considered ineligible for enrollment by investigators

Design outcomes

Primary

MeasureTime frame
2-year cumulative incidence of relapse after transplantation;

Secondary

MeasureTime frame
incidence of Grade ?-? acute graft-versus-host disease;incidence of chronic graft-versus-host disease;2-year survival after transplantation;2-year leukemia-free survival after transplantation;

Countries

China

Contacts

Public ContactYang Sitian

Shenzhen Second People's Hospital

youylt@126.com+86 755 8336 6388

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026