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)
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 45
- 试验地点
- 4
- 主要终点
- To evaluate the safety and tolerability of polatuzumab vedotin
研究概览
简要总结
Prospective, non-interventional study with primary data collection. This study will evaluate the safety of polatuzumab vedotin in the treatment of transplant ineligible patients with R/R DLBCL in the real-world setting of common clinical practice in India. This study will include patients that have received at least one dose of polatuzumab vedotin
according to currently approved indication in transplant ineligible R/R DLBCL in India. Patients will be treated, followed, and monitored by their physicians according to local clinical practice. There are no specific visits planned by protocol. However, baseline (first dose of study treatment) and follow up data will be gathered from the medical records at the moment of inclusion in this study up to 8 weeks after completing the treatment or receiving last dose. Data will be collected prospectively and/or retrospectively from the medical records. Patients included in the study are expected to be followed up 8 weeks after receiving last dose (observational period) unless death, lost to follow-up or withdrawal of consent, whichever occurs first.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
To evaluate the safety and tolerability of polatuzumab vedotin
时间窗: Day 0 (baseline), Day 168 and Day 182
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 practice
时间窗: Day 0 (baseline), Day 168 and Day 182
次要结局
- 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.(182 days)
研究者
Dr Pankaj Malhotra
Postgraduate Institute of Medical Education & Research(PGIMER)