Study on Stem Cell Transplant Followed by Polatuzumab Vedotin for B-cell Non-Hodgkin and Hodgkin Lymphoma
Sponsor: New York Medical College
ClinicalTrials ID:NCT04491370
This clinical trial is testing a treatment plan that includes a stem cell transplant followed by the drug Polatuzumab Vedotin for patients with certain types of B-cell Non-Hodgkin and Hodgkin Lymphoma. The study aims to see if this approach can help control the disease.
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Program Overview
In this study, patients with B-cell Non-Hodgkin and Hodgkin Lymphoma will first receive a stem cell transplant after undergoing one of two pre-treatment regimens. If their cancer shows a complete, partial, or stable response after the transplant, they will then receive Polatuzumab Vedotin through an IV every 21 days for a total of 8 doses. After completing this treatment, patients will have follow-up visits every 4 months for about 2 years to monitor their health and the effectiveness of the treatment.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with specific types of B-cell Non-Hodgkin or Hodgkin Lymphoma, such as Burkitt lymphoma or Diffuse Large B Cell Lymphoma.
- The cancer must have either not responded to initial treatment or returned after treatment, but shows some response to re-treatment.
- Must have a performance status score of at least 50%, indicating the ability to carry out daily activities.
- Expected to live for more than 6 weeks.
- Must have recovered from any side effects of previous cancer treatments.
- Must have adequate kidney, liver, heart, and lung function as determined by specific medical tests.
- Must have a sufficient number of stem cells collected and stored before starting the treatment.
- Must provide written informed consent to participate in the study.
Exclusion Criteria
- Cannot have had a previous stem cell transplant.
- Cannot have active cancer in the central nervous system.
- Cannot be taking other experimental treatments for B-cell lymphoma.
- Cannot be pregnant or breastfeeding.
- Must agree to use effective birth control if sexually active and able to have children.
- Cannot have an uncontrolled infection.
- Cannot have severe nerve damage (Grade 3 or higher neuropathy).
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