Relapsed Non Hodgkin LymphomaNCT05006534
Polatuzumab Vedotin in Patients With Relapsed and Refractory Diffuse Large B Cell Lymphoma
An observational study of Relapsed Non Hodgkin Lymphoma and Refractory Lymphoma, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
This study enrolled patients with relapsed or refractory diffuse large B cell lymphoma treated with polatuzumab vedotin-based chemoimmunotherapies. Patients were allowed to use chemotherapy regimens other than Rituximab and Bendamustine and transplantation following polatuzumab vedotin was also allowed. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Relapsed Non Hodgkin Lymphoma, Refractory Lymphoma
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jun 2020to 29 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated with Polatuzumab vedotin
Who may be able to join
- The informed consent form must be signed before any study specific tests or procedures are done
- Adult male and female patients ≥20 years at the time of inclusion in the study Ability to understand and follow study-related instructions
- Histological diagnosis of primary refractory or relapsed aggressive B-cell non-Hodgkin lymphoma (B-NHL), confirmed by a biopsy of involved nodal or extranodal site. Patients with any of the following histologies can be included:
- DLBCL not otherwise specified (NOS)
- T-cell/histiocyte-rich large B-cell lymphoma
- Primary cutaneous DLBCL, leg type
Show all 13Show fewer
- Epstein-Barr virus (EBV)-positive DLBCL, NOS
- DLBCL associated with chronic inflammation
- Primary mediastinal (thymic) large B-cell lymphoma Refractory disease is defined as no complete remission to first line therapy. Relapsed disease is defined as complete remission to first line therapy followed by disease relapse.
- Subjects must have received adequate first line therapy including at a minimum: i) anti-CD20 monoclonal antibody unless Investigator determines that tumor is CD20 negative, and ii) an anthracycline containing chemotherapy Regimen
- Women of childbearing potential must have a negative pregnancy test result within 7 days prior to the first study drug Administration
- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating eggs
- For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm
Who cannot join
- Primary or secondary central nervous system (CNS) lymphoma at the time of recruitment
- Richter's transformation or prior chronic lymphocytic leukemia (CLL)
- Vaccination with a live vaccine within 4 weeks prior to Treatment
- Received polatuzumab vedotin as part of the first line therapy
- Ongoing treatment or study procedures within any other Investigational Medicinal Product (IMP) clinical trial with the exception of follow-up. In case of a preceding clinical trial, last application of the respective IMP(s) must have been done more than five elimination half-lives before start of study medication in this trial.
- History of severe allergic or anaphylactic reactions to human, humanized, chimeric, or murine monoclonal antibodies
- History of hypersensitivity to any of the study drugs or their ingredients or to drugs with similar structure
- Pregnancy or breastfeeding, or intending to become pregnant during the study or within 12 months after the last dose of study drug
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy and Adverse Effect of Polatuzumab Vedotin in Patients With Diffuse Large B Cell Lymphoma: an Observation Study
This study enrolled patients with relapsed or refractory diffuse large B cell lymphoma treated with polatuzumab vedotin-based chemoimmunotherapies. Patients were allowed to use chemotherapy regimens other than Rituximab and Bendamustine and transplantation following polatuzumab vedotin was also allowed.
Read the detailed description
Polatuzumab vedotin has been demonstrated to be an effective treatment for patients with relapsed/refractory diffuse large B cell lymphoma in an international phase II clinical trial. The clinical trials was conducted in Europe and the United States. Although there is a phase III trial about polatuzumab vedotin in newly diagnosed patients with diffuse large B cell lymphoma, the double-blind design has limited the efficacy assessment and side effect observation, making it difficult to provide clinicians with further information.
This program hopes to evaluate the clinical course and treatment response of these patients in order to facilitate clinicians' understanding of this drug and to improve patients' quality of life and medical care, as well as to prevent the occurrence of related complications and treatment toxicity.
- Conditions
- Relapsed Non Hodgkin Lymphoma, Refractory Lymphoma
- Keywords
- Diffuse large B-cell lymphoma, Polatuzumab vedotin
- Medical subject headings
- Lymphoma, Non-Hodgkin, Lymphoma, Lymphoma, Large B-Cell, Diffuse
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
From the use of PoV to death related to any cause
Measured: through study completion, an average of 2 year
Secondary outcomes (2)
Overall response rate
The assessment is based on PET/CT or contrast CT, as determined by the investigator. Including complete remission and partial remission
Measured: through study completion, an average of 2 year
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Will estimate the safety and tolerability of polatuzumab vedotin when added to intensive chemotherapy regimens
Measured: through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2021
- Study start1 Jun 2020
- Primary completion29 Jun 2021
- Study completion29 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Relapsed Non Hodgkin LymphomaStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cheng-Hong Tsai, MD, MSc, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05006534
- Sponsor's protocol ID
- 202005095RINA
- Status last verified
- Aug 2021
- First submitted
- 1 Aug 2021
- Last updated
- 16 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Wang YW, Tsai XC, Hou HA, Tien FM, Liu JH, Chou WC, Ko BS, Chen YW, Lin CC, Cheng CL, Lo MY, Lin YC, Lu LC, Wu SJ, Kuo SH, Hong RL, Huang TC, Yao M. Polatuzumab vedotin-based salvage immunochemotherapy as third-line or beyond treatment for patients with diffuse large B-cell lymphoma: a real-world experience. Ann Hematol. 2022 Feb;101(2):349-358. doi: 10.1007/s00277-021-04711-9. Epub 2021 Nov 11.
PubMed 34766217
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Adverse Effect of Polatuzumab Vedotin in Patients With Diffuse Large B Cell Lymphoma: an Observation Study
- ClinicalTrials.gov ID
- NCT05006534
- Acronym / sponsor ID
- 202005095RINA
- Conditions
- Relapsed Non Hodgkin Lymphoma, Refractory Lymphoma
- Keywords
- Diffuse large B-cell lymphoma, Polatuzumab vedotin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 29 Jun 2021 (actual)
- Study completion
- 29 Jun 2021 (actual)
- First posted
- 16 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study enrolled patients with relapsed or refractory diffuse large B cell lymphoma treated with polatuzumab vedotin-based chemoimmunotherapies. Patients were allowed to use chemotherapy regimens other than Rituximab and Bendamustine and transplantation following polatuzumab vedotin was also allowed.
Detailed description
Polatuzumab vedotin has been demonstrated to be an effective treatment for patients with relapsed/refractory diffuse large B cell lymphoma in an international phase II clinical trial. The clinical trials was conducted in Europe and the United States. Although there is a phase III trial about polatuzumab vedotin in newly diagnosed patients with diffuse large B cell lymphoma, the double-blind design has limited the efficacy assessment and side effect observation, making it difficult to provide clinicians with further information.
This program hopes to evaluate the clinical course and treatment response of these patients in order to facilitate clinicians' understanding of this drug and to improve patients' quality of life and medical care, as well as to prevent the occurrence of related complications and treatment toxicity.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated with Polatuzumab vedotin
Key inclusion criteria (13 listed)
- The informed consent form must be signed before any study specific tests or procedures are done
- Adult male and female patients ≥20 years at the time of inclusion in the study Ability to understand and follow study-related instructions
- Histological diagnosis of primary refractory or relapsed aggressive B-cell non-Hodgkin lymphoma (B-NHL), confirmed by a biopsy of involved nodal or extranodal site. Patients with any of the following histologies can be included:
- Subjects must have received adequate first line therapy including at a minimum: i) anti-CD20 monoclonal antibody unless Investigator determines that tumor is CD20 negative, and ii) an anthracycline containing chemotherapy Regimen
- Women of childbearing potential must have a negative pregnancy test result within 7 days prior to the first study drug Administration
Key exclusion criteria (8 listed)
- Primary or secondary central nervous system (CNS) lymphoma at the time of recruitment
- Richter's transformation or prior chronic lymphocytic leukemia (CLL)
- Vaccination with a live vaccine within 4 weeks prior to Treatment
- Received polatuzumab vedotin as part of the first line therapy
- Ongoing treatment or study procedures within any other Investigational Medicinal Product (IMP) clinical trial with the exception of follow-up. In case of a preceding clinical trial, last application of the respective IMP(s) must have been done more than five elimination half-lives before start of study medication in this trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall Survival
Time frame: through study completion, an average of 2 year
From the use of PoV to death related to any cause
2 secondary outcomes
Overall response rate
Time frame: through study completion, an average of 2 year
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: through study completion, an average of 2 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2021.
- Derived from this study: PubMed 34766217Wang YW, Tsai XC, Hou HA, Tien FM, Liu JH, Chou WC, Ko BS, Chen YW, Lin CC, Cheng CL, Lo MY, Lin YC, Lu LC, Wu SJ, Kuo SH, Hong RL, Huang TC, Yao M. Polatuzumab vedotin-based salvage immunochemotherapy as third-line or beyond treatment for patients with diffuse large B-cell lymphoma: a real-world experience. Ann Hematol. 2022 Feb;101(2):349-358. doi: 10.1007/s00277-021-04711-9. Epub 2021 Nov 11.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cheng-Hong Tsai, MD, MSc, PhD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Relapsed Non Hodgkin Lymphoma and Refractory Lymphoma, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: through study completion, an average of 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05006534, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2021.