Skip to content

Efficacy and Safety of Polatuzumab Vedotin combined with rituximab and dexamethasone in the treatment of elderly fragile patients with newly diagnosed diffuse large B-cell lymphoma

Efficacy and Safety of Polatuzumab Vedotin combined with rituximab and dexamethasone in the treatment of elderly fragile patients with newly diagnosed diffuse large B-cell lymphoma

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400092977
Enrollment
Unknown
Registered
2024-11-26
Start date
2024-12-01
Completion date
Unknown
Last updated
2024-12-02

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

Conditions

Diffuse large B cell lymphoma

Interventions

observation group:The enrolled patients were treated with polatuzumab vedotin (Pola) combined with rituximab (R) and dexamethasone: Pola 1.8mg/kg IV day1, R 375mg/m2 IV day1, dexamethasone 15mgQd day1

Sponsors

Beijing hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to No maximum

Inclusion criteria

Inclusion criteria: 1) CD20-positive diffuse large B-cell lymphoma was diagnosed according to the 5th edition of the World Health Organization (WHO) classification of hematopoietic and lymphocytic neoplasms; 2) no previous lymphoma-related treatment; 3) age =80 years old or age=65 years old and FIL-CGA score for fragile groups; 4) presence of at least one measurable lesion; 5) the expected survival time is more than 3 months; 6) Patients voluntarily agreed to participate in the study and signed an informed consent form.

Exclusion criteria

Exclusion criteria: 1) severe uncontrolled infection or autoimmune disease; 2) the baseline liver and kidney dysfunction (alanine aminotransferase and aspartate aminotransferase levels more than 2 times the upper limit of normal (ULN), alkaline phosphatase (or bilirubin level more than 1.5 x ULN, creatinine level more than 1.5 x ULN); 3) active hepatitis B or C (HBsAg positive and/or HBcAb positive and HBV DNA = 104 copies or = 4000IU/ml; HCV antibody positive) or human immunodeficiency virus (HIV) antibody positive; 4) known allergy to the test drug; 5) those who were considered unsuitable for enrollment by the researchers; 6) in patients with poor compliance

Design outcomes

Primary

MeasureTime frame
Overall Response Rate;

Secondary

MeasureTime frame
Overall survival rate;progression-free rate;

Countries

China

Contacts

Public ContactHui Liu

Beijing hospital

liuhui3218@bjhmoh.cn+86 135 2061 8812

Outcome results

None listed

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