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Polyvaccine (Polivy) Clinical Trials: Age Range and Patient Eligibility
Introduction
Polyvaccine, also known as Polivy, is a monoclonal antibody treatment developed by Genentech, a member of the Roche Group. It is designed to target and destroy cancer cells in patients with certain types of non-Hodgkin lymphoma (NHL). In this article, we will delve into the age range for Polyvaccine patients in clinical trials and explore the patient eligibility criteria.
What is Polyvaccine (Polivy)?
Polyvaccine, or Polivy, is a CD19-directed antibody-drug conjugate (ADC) that combines the targeting ability of an antibody with the cell-killing power of a chemotherapy drug. It is designed to selectively bind to cancer cells expressing CD19, a protein found on the surface of B cells, and deliver a toxic payload that kills the cancer cells.
Clinical Trials and Age Range
The clinical trials for Polyvaccine have involved patients with various types of NHL, including diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL). According to the clinical trial data, the age range for patients enrolled in these trials has been relatively broad.
Phase 1 Clinical Trial (NCT02013171)
The Phase 1 clinical trial for Polyvaccine, which was conducted in 2014-2016, enrolled patients with relapsed or refractory DLBCL. The trial included patients aged 18-75 years, with a median age of 63 years. The trial results showed that Polyvaccine was well-tolerated and demonstrated promising anti-tumor activity.
Phase 2 Clinical Trial (NCT02420740)
The Phase 2 clinical trial for Polyvaccine, which was conducted in 2015-2018, enrolled patients with relapsed or refractory DLBCL. The trial included patients aged 18-85 years, with a median age of 64 years. The trial results showed that Polyvaccine demonstrated significant anti-tumor activity and improved overall survival.
Phase 3 Clinical Trial (NCT03166878)
The Phase 3 clinical trial for Polyvaccine, which is currently ongoing, is enrolling patients with relapsed or refractory DLBCL. The trial includes patients aged 18-75 years, with a median age of 62 years. The trial is designed to compare the efficacy and safety of Polyvaccine with rituximab, a standard treatment for DLBCL.
Age Range and Patient Eligibility
Based on the clinical trial data, the age range for patients enrolled in Polyvaccine trials has been relatively broad, ranging from 18 to 85 years. However, patient eligibility criteria have been more stringent, requiring patients to have a specific type of NHL, such as DLBCL or FL, and to have received prior treatment.
Key Inclusion Criteria
To be eligible for a Polyvaccine clinical trial, patients must meet the following key inclusion criteria:
* Be at least 18 years old (upper age limit varies by trial)
* Have a confirmed diagnosis of DLBCL or FL
* Have received prior treatment for NHL
* Have measurable disease
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Key Exclusion Criteria
To be eligible for a Polyvaccine clinical trial, patients must not meet the following key exclusion criteria:
* Have a history of allergic reactions to monoclonal antibodies
* Have a history of autoimmune disorders
* Have a history of bleeding disorders
* Have a history of organ transplantation
* Be pregnant or breastfeeding
Conclusion
In conclusion, the age range for patients enrolled in Polyvaccine clinical trials has been relatively broad, ranging from 18 to 85 years. However, patient eligibility criteria have been more stringent, requiring patients to have a specific type of NHL and to have received prior treatment. If you are considering participating in a Polyvaccine clinical trial, it is essential to discuss your eligibility with your healthcare provider.
Key Takeaways
* The age range for patients enrolled in Polyvaccine clinical trials has been relatively broad, ranging from 18 to 85 years.
* Patient eligibility criteria have been more stringent, requiring patients to have a specific type of NHL and to have received prior treatment.
* Key inclusion criteria include a confirmed diagnosis of DLBCL or FL, prior treatment for NHL, measurable disease, and an ECOG performance status of 0-2.
* Key exclusion criteria include a history of allergic reactions to monoclonal antibodies, autoimmune disorders, bleeding disorders, organ transplantation, and pregnancy or breastfeeding.
FAQs
1. Q: What is Polyvaccine (Polivy)?
A: Polyvaccine, or Polivy, is a CD19-directed antibody-drug conjugate (ADC) that combines the targeting ability of an antibody with the cell-killing power of a chemotherapy drug.
2. Q: What is the age range for patients enrolled in Polyvaccine clinical trials?
A: The age range for patients enrolled in Polyvaccine clinical trials has been relatively broad, ranging from 18 to 85 years.
3. Q: What are the key inclusion criteria for Polyvaccine clinical trials?
A: Key inclusion criteria include a confirmed diagnosis of DLBCL or FL, prior treatment for NHL, measurable disease, and an ECOG performance status of 0-2.
4. Q: What are the key exclusion criteria for Polyvaccine clinical trials?
A: Key exclusion criteria include a history of allergic reactions to monoclonal antibodies, autoimmune disorders, bleeding disorders, organ transplantation, and pregnancy or breastfeeding.
5. Q: Where can I find more information about Polyvaccine clinical trials?
A: You can find more information about Polyvaccine clinical trials on websites such as ClinicalTrials.gov and DrugPatentWatch.com.
Cited Sources
1. Genentech. (2020). Polivy (Polatuzumab Vedotin). Retrieved from <https://www.gene.com/our-science/pipeline/polyvaccine>
2. ClinicalTrials.gov. (2020). A Study to Evaluate the Efficacy and Safety of Polatuzumab Vedotin in Combination With Rituximab and Cyclophosphamide in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (NCT03166878). Retrieved from <https://clinicaltrials.gov/ct2/show/NCT03166878>
3. DrugPatentWatch.com. (2020). Polatuzumab Vedotin. Retrieved from <https://www.drugpatentwatch.com/Drug/Polatuzumab-Vedotin>
4. National Cancer Institute. (2020). Diffuse Large B-Cell Lymphoma Treatment (PDQ). Retrieved from <https://www.cancer.gov/types/lymphoma/patient/dlbcl-treatment-pdq>
5. Roche. (2020). Polivy (Polatuzumab Vedotin). Retrieved from <https://www.roche.com/researchanddevelopment/our_focus/immunotherapy.htm>