Patient's Outcome Prognostic FactorsNCT03663894
Clinical Characteristics and Outcomes of Relapsed Follicular Lymphoma After Autologous Stem Cell Transplantation at Rituximab Era
An observational study of Patient's Outcome Prognostic Factors, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Introduction High dose chemotherapy followed by Autologous Stem Cell Transplantation (ASCT) is a therapeutic option in follicular Lymphoma after first line treatment failure. The clinical characteristics and outcome of FL patients who relapsed after HDT+ASCT and therapeutic management in the rituximab era are not well… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient's Outcome Prognostic Factors
- How many people
- 95 participants
- Where
- 1 siteFrance
- Study dates
- 30 Jul 2017to 31 Jul 2018
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: 95 consecutive patients who fulfilled the eligibility criteria for this study were reviewed retrospectively with data cut-off of December 2014. FL patients in relapse after ASCT. All patients presented at diagnosis a grade 1, 2, or 3A follicular lymphoma confirmed by either excisional or core needle biopsy.
Who may be able to join
- they were older than 18 years
- presented FL at diagnosis (Grade 1, 2, or 3a).
- received high-dose therapy (HDT) with ASCT from 2000 to 2014
Who cannot join
- they had already been treated with a 1st ASCT,
- had a previous history of histological transformation before ASCT
- if they were rituximab naive prior to ASCT.
Trial locations and contacts
1 site in 1 country.
About this study
Introduction High dose chemotherapy followed by Autologous Stem Cell Transplantation (ASCT) is a therapeutic option in follicular Lymphoma after first line treatment failure. The clinical characteristics and outcome of FL patients who relapsed after HDT+ASCT and therapeutic management in the rituximab era are not well known and may represent a difficult challenge.
Patients and Methods: The investigators conducted a retrospective analysis of FL patients who relapsed after HDT+ASCT in four French centers treated between 2000 and 2014. Clinical records were reviewed for clinical characteristics and treatment strategy at relapse. The investigators aimed to identify prognostic factors related to patient's outcome.
- Conditions
- Patient's Outcome Prognostic Factors
- Keywords
- Autologous stem cell transplantation, rituximab, Follicular Lymphoma, prognosis
- Medical subject headings
- Lymphoma, Follicular
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival after relapse (SAR) post ASCT in follicular lymphoma
Factors that predicted SAR
Measured: Year 6
Secondary outcomes (2)
Histological Transformation at relapse
A biopsy was performed at the first relapse or progression after ASCT.
Measured: Year 6
treatment of relapse
Chemotherapy, radiotherapy…
Measured: Year 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2018
- Study start30 Jul 2017
- Primary completion15 Dec 2017
- Study completion31 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient's Outcome Prognostic FactorsStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre SESQUES, MD, Study director, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03663894
- Sponsor's protocol ID
- ASCT Sesques
- Status last verified
- Sep 2018
- First submitted
- 22 Aug 2018
- Last updated
- 10 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Characteristics and Outcomes of Relapsed Follicular Lymphoma After Autologous Stem Cell Transplantation at Rituximab Era
- ClinicalTrials.gov ID
- NCT03663894
- Acronym / sponsor ID
- ASCT Sesques
- Conditions
- Patient's Outcome Prognostic Factors
- Keywords
- Autologous stem cell transplantation, rituximab, Follicular Lymphoma, prognosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 30 Jul 2017 (actual)
- Primary completion
- 15 Dec 2017 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 10 Sep 2018 (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.
Introduction High dose chemotherapy followed by Autologous Stem Cell Transplantation (ASCT) is a therapeutic option in follicular Lymphoma after first line treatment failure. The clinical characteristics and outcome of FL patients who relapsed after HDT+ASCT and therapeutic management in the rituximab era are not well known and may represent a difficult challenge.
Patients and Methods: The investigators conducted a retrospective analysis of FL patients who relapsed after HDT+ASCT in four French centers treated between 2000 and 2014. Clinical records were reviewed for clinical characteristics and treatment strategy at relapse. The investigators aimed to identify prognostic factors related to patient's outcome.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 95 consecutive patients who fulfilled the eligibility criteria for this study were reviewed retrospectively with data cut-off of December 2014. FL patients in relapse after ASCT. All patients presented at diagnosis a grade 1, 2, or 3A follicular lymphoma confirmed by either excisional or core needle biopsy.
Key inclusion criteria (3 listed)
- they were older than 18 years
- presented FL at diagnosis (Grade 1, 2, or 3a).
- received high-dose therapy (HDT) with ASCT from 2000 to 2014
Key exclusion criteria (3 listed)
- they had already been treated with a 1st ASCT,
- had a previous history of histological transformation before ASCT
- if they were rituximab naive prior to ASCT.
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
Survival after relapse (SAR) post ASCT in follicular lymphoma
Time frame: Year 6
Factors that predicted SAR
2 secondary outcomes
Histological Transformation at relapse
Time frame: Year 6
treatment of relapse
Time frame: Year 6
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 10 Sep 2018.
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.
Pierre SESQUES, MD study director
Hospices Civils de Lyon
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 Patient's Outcome Prognostic Factors, run by Hospices Civils de Lyon at 1 site in France.
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 3 inclusion and 3 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 10 Sep 2018. 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 France. 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?
Survival after relapse (SAR) post ASCT in follicular lymphoma (time frame: Year 6). 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 10 Sep 2018.