A multi-institutional observational study of newly-diagnosed CD5-positive diffuse large B-cell lymphoma after the introduction of new therapies in Japan

A multi-institutional observational study of newly-diagnosed CD5-positive diffuse large B-cell lymphoma after the introduction of new therapies in Japan - CD5+ DLBCL new-era project

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000049460

Enrollment

300

Registered

2022-11-09

Start date

2022-11-10

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

CD5-positive diffuse large B-cell lymphoma (CD5+ DLBCL)

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who meet either 1 or 2 below are eligible. 1. Patients who were diagnosed as newly-diagnosed with DLBCL, not otherwise specified (WHO classification) between January 1, 2016 and December 31, 2021 at participating institutions 2. DLBCL cells are confirmed to be CD5-positive by flow cytometry and/or immunohistochemistry.

Exclusion criteria

Exclusion criteria: Patients with one or more of the following are excluded. 1. Patients who were diagnosed as not CD5+ DLBCL based on diagnosis-related information 2. Patients who refused to consent to opt-out

Design outcomes

Primary

Measure	Time frame
Overall survival of patients with newly-diagnosed CD5+ DLBCL in 2016-2021 at participating institutes	—

Secondary

Measure	Time frame
1. Clinical features, treatment, toxicity profile, and risk factors affecting survival of CD5+ DLBCL patients in 2016-2021 at participating institutes 2. Efficacy and safety of PEARL5 therapy for CD5+ DLBCL in clinical practice compared with the results of PEARL5 study 3. Efficacy of PEARL5 therapy for CD5+ DLBCL in clinical practice compared with the results of our previous retrospective study (CD5+ DLBCL R-era project)	—

Measure

Time frame

1. Clinical features, treatment, toxicity profile, and risk factors affecting survival of CD5+ DLBCL patients in 2016-2021 at participating institutes 2. Efficacy and safety of PEARL5 therapy for CD5+ DLBCL in clinical practice compared with the results of PEARL5 study 3. Efficacy of PEARL5 therapy for CD5+ DLBCL in clinical practice compared with the results of our previous retrospective study (CD5+ DLBCL R-era project)

—

Countries

Japan

Contacts

Public ContactMotoko Yamaguchi

Mie University Graduate School of Medicine Department of Hematological Malignancies

myamaguchi@clin.medic.mie-u.ac.jp059-231-9072

Outcome results