General Drug Use Surveillance (All-Patient Surveillance) of POLIVY for Intravenous Infusion 30mg and 140mg (polatuzumab vadotin [genetical recombination]) -Relapsed or refractory diffuse large B-cell lymphoma-

General Drug Use Surveillance (All-Patient Surveillance) of POLIVY for Intravenous Infusion 30mg and 140mg (polatuzumab vadotin [genetical recombination]) -Relapsed or refractory diffuse large B-cell lymphoma- - General Drug Use Surveillance (All-Patient Surveillance) of POLIVY for Intravenous Infusion 30mg and 140mg (polatuzumab vadotin [genetical recombination]) -Relapsed or refractory diffuse large B-cell lymphoma-

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000043840

Enrollment

400

Registered

2021-05-19

Start date

2021-05-19

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

Relapsed or refractory diffuse large B-cell lymphoma

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients eligible for enrollment: All patients expected to receive POLIVY during the enrollment period. All patients who have participated in clinical trials of POLIVY will be subject for all-patient surveillance from the date of administration of the marketed POLIVY for intravenous infusion 30 mg and 140 mg.

Exclusion criteria

Exclusion criteria: None

Design outcomes

Primary

Measure	Time frame
Major surveillance items, etc. 1) Institution information Name of institution, name of department, name of physician 2) Patient demographics Patient initials, age at treatment initiation, ID number, reason for use, history of hypersensitivity to the ingredients of POLIVY, sex, pregnancy, date of initial diagnosis, height, weight, performance status (ECOG PS), NCCN-IPI (NCCN-International Prognostic Index), disease stage classification, treatment line, previous disease, concurrent disease 3) Previous treatment (Yes/No), and if yes: Name of chemotherapy (rituximab + CHOP, high-dose chemotherapy with autologous hematopoietic stem cell transplantation, salvage chemotherapy, radiation therapy, other) 4) POLIVY treatment status Dose per administration, administration date, status at completion of observation period (ongoing, suspended, discontinued [reason for discontinuation in patients who discontinued treatment], completed) 5) Concomitant chemotherapy (Yes/No), and if yes: Name of chemotherapy (bendamustine, rituximab, other), therapy start date, therapy stop date 6) Prophylaxis treatment for infections (Yes/No), and if yes: Drug name, treatment start date, treatment end date 7) Adverse event (Yes/No), and if yes: adverse event name, date of onset, worst grade, seriousness, action taken (POLIVY, other), outcome, date of outcome, causal relationship (POLIVY, other factors) If serious, comments and laboratory test values related to adverse event	—

Measure

Time frame

Major surveillance items, etc. 1) Institution information Name of institution, name of department, name of physician 2) Patient demographics Patient initials, age at treatment initiation, ID number, reason for use, history of hypersensitivity to the ingredients of POLIVY, sex, pregnancy, date of initial diagnosis, height, weight, performance status (ECOG PS), NCCN-IPI (NCCN-International Prognostic Index), disease stage classification, treatment line, previous disease, concurrent disease 3) Previous treatment (Yes/No), and if yes: Name of chemotherapy (rituximab + CHOP, high-dose chemotherapy with autologous hematopoietic stem cell transplantation, salvage chemotherapy, radiation therapy, other) 4) POLIVY treatment status Dose per administration, administration date, status at completion of observation period (ongoing, suspended, discontinued [reason for discontinuation in patients who discontinued treatment], completed) 5) Concomitant chemotherapy (Yes/No), and if yes: Name of chemotherapy (bendamustine, rituximab, other), therapy start date, therapy stop date 6) Prophylaxis treatment for infections (Yes/No), and if yes: Drug name, treatment start date, treatment end date 7) Adverse event (Yes/No), and if yes: adverse event name, date of onset, worst grade, seriousness, action taken (POLIVY, other), outcome, date of outcome, causal relationship (POLIVY, other factors) If serious, comments and laboratory test values related to adverse event

—

Countries

Japan

Contacts

Public ContactRyousue Harada

Chugai Pharmaceutical Co. Ltd. Safety Science Dept.

haradarus@chugai-pharm.co.jp03-3281-6611

Outcome results