Refractory B-Cell Non-Hodgkin LymphomaNCT02992223
Retrospective Analysis on Relapsed/Refractory Aggressive Non Hodgkin Lymphoma Treated With Z-BEAM Plus ASCT
An observational study of Refractory B-Cell Non-Hodgkin Lymphoma and Recurrent B-Cell Non-Hodgkin Lymphoma, run by A.O.U. Città della Salute e della Scienza.
Trial summary
Evaluate if Y90 Ibritumomab Tiuxetan Radioimmunotherapy in addition to standard high dose chemotherapy followed by autologous stem cell transplant could improve prognosis in patients affected by relapsed/refractory aggressive non Hodgkin lymphoma Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Refractory B-Cell Non-Hodgkin Lymphoma, Recurrent B-Cell Non-Hodgkin Lymphoma
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- Jul 2014to Jul 2015
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient With Relapsed/Refractory Aggressive Non Hodgkin Lymphoma treated with Y90 Ibritumomab Tiuxetan Radioimmunotherapy Plus High-Dose Chemotherapy and Autologous Stem Cell Transplant
Who may be able to join
- High Risk Relapsed/refractory aggressive non-hodgkin lymphoma defined as:
- Progressive disease
- Early relapse (within 12 months from response)
- Recurrent relapse
- Treated with salvage chemotherapy followed by Y90 Ibritumomab Tiuxetan plus high-dose chemotherapy and Autologous stem cell transplant
- Age > 18 years
- Previous treatment with Rituximab
- Written informed consent
Who cannot join
- Patient with no complete data available for collection
About this study
Official title: Retrospective Collection of Data on Patient With Relapsed/Refractory Aggressive Non Hodgkin Lymphoma Treated With Y90 Ibritumomab Tiuxetan Radioimmunotherapy Plus High-Dose Chemotherapy and Autologous Stem Cell Transplant
Evaluate if Y90 Ibritumomab Tiuxetan Radioimmunotherapy in addition to standard high dose chemotherapy followed by autologous stem cell transplant could improve prognosis in patients affected by relapsed/refractory aggressive non Hodgkin lymphoma
- Keywords
- Aggressive B-cell non-Hodgkin Lymphoma, Relapsed, Refractory, Zevalin, Y90 Ibritumomab Tiuxetan, Autologous stem cell transplant, BEAM, Recurrent
- Medical subject headings
- Lymphoma, B-Cell, Recurrence
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Time to last follow-up or death
Measured: Date of last follow-up for at least 18 months (up to 78 months)
Progression Free Survival
Time from last response to nearest relapse or follow-up
Measured: From first response to last follow-up for at least 18 month (up to 78 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2016 (estimated)
- Study startJul 2014
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory B-Cell Non-Hodgkin LymphomaStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- A.O.U. Città della Salute e della Scienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barbara Botto, A.O.U. Città della Salute e della Scienza
- Investigators
- Barbara Botto, MD, Principal investigator, A.O.U. Città della Salute e della Scienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02992223
- Sponsor's protocol ID
- Oss_Z-BEAM
- Status last verified
- Dec 2016
- First submitted
- 12 Dec 2016
- Last updated
- 14 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: paper publication
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Collection of Data on Patient With Relapsed/Refractory Aggressive Non Hodgkin Lymphoma Treated With Y90 Ibritumomab Tiuxetan Radioimmunotherapy Plus High-Dose Chemotherapy and Autologous Stem Cell Transplant
- ClinicalTrials.gov ID
- NCT02992223
- Acronym / sponsor ID
- Oss_Z-BEAM
- Keywords
- Aggressive B-cell non-Hodgkin Lymphoma, Relapsed, Refractory, Zevalin, Y90 Ibritumomab Tiuxetan, Autologous stem cell transplant, BEAM, Recurrent
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- A.O.U. Città della Salute e della ScienzaUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 14 Dec 2016 (estimated)
- 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.
Evaluate if Y90 Ibritumomab Tiuxetan Radioimmunotherapy in addition to standard high dose chemotherapy followed by autologous stem cell transplant could improve prognosis in patients affected by relapsed/refractory aggressive non Hodgkin lymphoma
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient With Relapsed/Refractory Aggressive Non Hodgkin Lymphoma treated with Y90 Ibritumomab Tiuxetan Radioimmunotherapy Plus High-Dose Chemotherapy and Autologous Stem Cell Transplant
Key inclusion criteria (8 listed)
- High Risk Relapsed/refractory aggressive non-hodgkin lymphoma defined as:
- Progressive disease
- Early relapse (within 12 months from response)
- Recurrent relapse
- Treated with salvage chemotherapy followed by Y90 Ibritumomab Tiuxetan plus high-dose chemotherapy and Autologous stem cell transplant
Key exclusion criteria (1 listed)
- Patient with no complete data available for collection
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: Date of last follow-up for at least 18 months (up to 78 months)
Time to last follow-up or death
Progression Free Survival
Time frame: From first response to last follow-up for at least 18 month (up to 78 months)
Time from last response to nearest relapse or follow-up
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 14 Dec 2016.
- Individual participant dataSharing planned: Yes. paper publication
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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.
Barbara Botto, MD principal investigator
A.O.U. Città della Salute e della Scienza
Questions about this trial
What is this clinical trial studying?
An observational study of Refractory B-Cell Non-Hodgkin Lymphoma and Recurrent B-Cell Non-Hodgkin Lymphoma, run by A.O.U. Città della Salute e della Scienza.
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 8 inclusion and 1 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 14 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
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: Date of last follow-up for at least 18 months (up to 78 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Dec 2016.