Skip to content

A Single-Arm, Multicenter, Phase II Clinical Study of Reduced-Dose Chemotherapy Followed by Short-Course Blinatumomab for Continuous Immunotherapy in Newly Diagnosed Adult Patients with B-Cell Acute Lymphoblastic Leukemia (B-ALL)

A Single-Arm, Multicenter, Phase II Clinical Study of Reduced-Dose Chemotherapy Followed by Short-Course Blinatumomab for Continuous Immunotherapy in Newly Diagnosed Adult Patients with B-Cell Acute Lymphoblastic Leukemia (B-ALL)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600126853
Enrollment
Unknown
Registered
2026-06-17
Start date
2025-01-24
Completion date
Unknown
Last updated
2026-06-22

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

New diagnosis of acute lymphoblastic leukemia in adults using bevacizumab:None

Sponsors

HenanCancerHospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
15 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients newly diagnosed with B-ALL (bone marrow or peripheral blood blasts = 20%) according to WHO diagnostic criteria and confirmed by MICM testing, from January 2025 to December 2027; 2. Age 15–75 years; 3. Male or female; 4. Subjects treated with blinatumomab; 5. Patients fully understand and voluntarily provide written informed consent; 6. ECOG performance status score 0–3; 7. Expected survival time >= 3 months; 8. Liver function: total bilirubin = 30 mL/min; 10. Subjects provide informed consent for investigational therapy.

Exclusion criteria

Exclusion criteria: 1. T-cell acute lymphoblastic leukemia (T-ALL); 2. Minimal residual disease (MRD)-negative B-cell acute lymphoblastic leukemia (B-ALL); 3. Mature B-cell leukemia/lymphoma, B-lymphocytic lymphoma, or isolated extramedullary disease; 4. Acute mixed phenotype leukemia; 5. Complicated with central nervous system leukemia; 6. HIV infection, positive HBV-DNA, or positive HCV-RNA; 7. Patients with heart failure = Grade 2 and other patients considered ineligible by the investigator; 8. Female patients who are pregnant, lactating, or of childbearing potential without using effective contraception; 9. Patients with uncontrolled neurological or psychiatric disorders, mental disturbances, or cognitive impairment that may limit their ability to understand, comply with informed consent, and adhere to the study.

Design outcomes

Primary

MeasureTime frame
Objective Response Rate (ORR);MRD Clearance Rate;

Secondary

MeasureTime frame
Progression-Free Survival (PFS);Incidence of treatment-related severe infections (grade = 3) during induction therapy;Overall Survival (OS);Duration of myelosuppression;Event-Free Survival (EFS);Duration of Response (DOR);

Countries

China

Contacts

Public ContactQingsong Yin

Henan Cancer Hospital

jnyinqingsong@163.com+86 371 6558 7358

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 29, 2026