A phase II Study of Polatuzumab Vedotin in Combination with Rituximab plus Bendamustine in Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma

A phase II Study of Polatuzumab Vedotin (RO5541077) in Combination with Rituximab plus Bendamustine in Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223990

Enrollment

Registered

2018-08-01

Start date

2018-10-19

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

B cell Non-Hodgkin Lymphoma

Interventions

investigational material(s) Generic name etc : Polatuzumab Vedotin INN of investigational material : Polatuzumab Vedotin Therapeutic category code : 429 Other antitumor agents Dosage and Administratio

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Histologically confirmed CD20 positive DLBCL - Patients with relapsed or refractory diffuse large B-cell lymphoma who received at least one prior therapy - Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1, or 2. - Life expectancy of at least 24 weeks from enrollment - Bi-dimensionally measurable lesion (defined as >= 1.5 cm in its longest dimension) - Availability of tumor tissue or 13 unstained slides - Patients with sufficient hematological function

Exclusion criteria

Exclusion criteria: - Contraindication to bendamustine or rituximab - History of transformation of indolent lymphoma to DLBCL - Primary or secondary CNS (central nervous system) lymphoma - Patients with a medical history of double cancer with disease-free interval of less than 3 years or complicated with double cancer. - Prior allogeneic stem cell transplant - Eligibility for autologous hematopoietic stem cell transplant - Grade >= 2 peripheral neuropathy - Active infections - Patients with suspected or latent tuberculosis - Positive HBsAg, HBcAb, HBsAb (Patients who are positive test results for HBsAb and/or HBcAb only and undetectable HBV-DNA may be eligible) - Positive anti-HCV (Patients who are negative for HCV-RNA may be eligible) - Known HIV antibody positive status or infection with HTLV-1

Design outcomes

Primary

Measure	Time frame
efficacy Observation/inspection	—

Secondary

Measure	Time frame
efficacy Observation/inspection	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026