A study to evaluate the safety of test drug to treat patients with relapsed or refractory diffuse large Bcell lymphoma (DLBCL) in India

A Post-Marketing Surveillance (PMS) study to monitor the safety of polatuzumab vedotin (Polivy) in India when administered as per local prescribing information in patients with relapsed or refractory diffuse large Bcell lymphoma (DLBCL) - POLIVY

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2025/12/099510

Enrollment

Registered

2025-12-19

Start date

Unknown

Completion date

Unknown

Last updated

2026-01-12

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

Conditions

Health Condition 1: C833- Diffuse large B-cell lymphoma

Interventions

Intervention1: Polatuzumab vedotin: 1.8 mg/kg as an intravenous infusion every 21 days for 6 cycles. First cycle will be administered over 90 minutes, however subsequent infusions may be administered

Eligibility

Inclusion criteria

Inclusion criteria: 1.Adult patients with diagnosis of R R DLBCL who are not candidates for hematopoietic stem cell transplant. 2.Have received at least 1 dose of polatuzumab vedotin in R R DLBCL according to approved label. 3.Have signed the informed consent. 4.Age 18 to 80 yrs at the time of signing Informed Consent Form and willingness to comply with the study protocol requirements.

Exclusion criteria

Exclusion criteria: 1.History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies (or recombinant antibody-related fusion proteins) or known sensitivity or allergy to murine products. 2.Prior use of polatuzumab vedotin. 3.Polatuzumab vedotin containing trial or trial that include polatuzumab vedotin as an investigational agent Recent major surgery (within 6 weeks before the start of Cycle 1 Day 1) other than for diagnosis. 4.Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of polatuzumab vedotin or that may affect the interpretation of the results or render the patient at high risk from treatment complications.

Design outcomes

Primary

Measure	Time frame
To evaluate the safety and tolerability of polatuzumab vedotin in the treatment of transplant ineligible patients relapsed or refractory diffuse large B-cell lymphoma (DLBCL) in India through the incidence of all adverse events (serious and nonserious) based on usual clinical practiceTimepoint: Day 0 (baseline), Day 168 and Day 182	—

Secondary

Measure	Time frame
Investigator assessed Complete Response (CR) & Objective Response Rate (ORR) of CR or partial response (PR) at the end of treatment, based on usual clinical practice.Timepoint: 182 days	—

Countries

India

Contacts

Public ContactAmol Pawar

Roche Products (India) Pvt. Ltd.

jyotii.poddaar@roche.com9136064373

Outcome results

None listed

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