MyelofibrosisSYMFASCTNCT04282421
Survival in Myelofibrosis Patients After Allogeneic Hematopoietic Stem Cell Transplantation in Five Centers in France
An observational study of Myelofibrosis, run by Central Hospital, Nancy, France.
Trial summary
The investigators would like to conduct a retrospective study in five centers in France in the goal to evaluate the survival of patients receiving allogeneic hematopoietic stem cell transplantation for myelofibrosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelofibrosis
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2007to 1 Feb 2020
- 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: adult patients receiving allogeneic hematopoietic stem cell transplantation for myelofibrosis in five centers in France (Nancy, Besançon, Strasbourg, Pitié Salpètrière and Lyon) between 2007 and 2017
Who may be able to join
None listed.
Who cannot join
- age < 18 years old
About this study
Official title: Survival in Patients Receiving Allogeneic Hematopoietic Stem Cell Transplantation for Myelofibrosis in Five French Centers
The investigators would like to conduct a retrospective study in five centers in France in the goal to evaluate the survival of patients receiving allogeneic hematopoietic stem cell transplantation for myelofibrosis.
Read the detailed description
The allogeneic stem cell transplantation is the only curative treatment for myelofibrosis. However, because of complications such as infection, graft-versus-host disease and conditioning toxicity, this procedure is associated with a high morbidity-mortality rate. The discovery of molecular and genetic markers permitted to improve therapeutic strategy and survival of patient in the last few years. In this study, the investigators want to make an overview of survival, incidence of relapse and incidence of acute and chronic graft versus host disease in allogeneic stem cell transplantation for myelofibrosis, in five centers in France, between 2007 and 2017.
- Conditions
- Myelofibrosis
- Keywords
- allogeneic hematopoietic stem cell transplantation, survival, graft versus host disease
- Medical subject headings
- Primary Myelofibrosis, Graft vs Host Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
survival
incidence of survival in the cohort
Measured: at 1 year
Secondary outcomes (3)
incidence of relapse
incidence of relapse in the cohort
Measured: at 1 year
incidence of acute graft versus host disease
incidence of acute graft versus host disease in the cohort
Measured: at 3 months
incidence of chronic graft versus host disease
incidence of chronic graft versus host disease in the cohort
Measured: at 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2020
- Study start1 Jan 2007
- Primary completion31 Dec 2017
- Study completion1 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MyelofibrosisStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04282421
- Sponsor's protocol ID
- 2020PI014
- Acronym
- SYMFASCT
- Status last verified
- Feb 2020
- First submitted
- 21 Feb 2020
- Last updated
- 12 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kroger N, Panagiota V, Badbaran A, Zabelina T, Triviai I, Araujo Cruz MM, Shahswar R, Ayuk F, Gehlhaar M, Wolschke C, Bollin R, Walter C, Dugas M, Wiehlmann L, Lehmann U, Koenecke C, Chaturvedi A, Alchalby H, Stadler M, Eder M, Christopeit M, Gohring G, Koenigsmann M, Schlegelberger B, Kreipe HH, Ganser A, Stocking C, Fehse B, Thol F, Heuser M. Impact of Molecular Genetics on Outcome in Myelofibrosis Patients after Allogeneic Stem Cell Transplantation. Biol Blood Marrow Transplant. 2017 Jul;23(7):1095-1101. doi: 10.1016/j.bbmt.2017.03.034. Epub 2017 Apr 4.
PubMed 28389256Hussein K, Stucki-Koch A, Alchalby H, Triviai I, Kroger N, Kreipe H. Cytokine Expression Pattern in Bone Marrow Microenvironment after Allogeneic Stem Cell Transplantation in Primary Myelofibrosis. Biol Blood Marrow Transplant. 2016 Apr;22(4):644-650. doi: 10.1016/j.bbmt.2015.12.006. Epub 2015 Dec 19.
PubMed 26708839
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survival in Patients Receiving Allogeneic Hematopoietic Stem Cell Transplantation for Myelofibrosis in Five French Centers
- ClinicalTrials.gov ID
- NCT04282421
- Acronym / sponsor ID
- SYMFASCT / 2020PI014
- Conditions
- Myelofibrosis
- Keywords
- allogeneic hematopoietic stem cell transplantation, survival, graft versus host disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Jan 2007 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 1 Feb 2020 (actual)
- First posted
- 24 Feb 2020 (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.
The investigators would like to conduct a retrospective study in five centers in France in the goal to evaluate the survival of patients receiving allogeneic hematopoietic stem cell transplantation for myelofibrosis.
Detailed description
The allogeneic stem cell transplantation is the only curative treatment for myelofibrosis. However, because of complications such as infection, graft-versus-host disease and conditioning toxicity, this procedure is associated with a high morbidity-mortality rate. The discovery of molecular and genetic markers permitted to improve therapeutic strategy and survival of patient in the last few years. In this study, the investigators want to make an overview of survival, incidence of relapse and incidence of acute and chronic graft versus host disease in allogeneic stem cell transplantation for myelofibrosis, in five centers in France, between 2007 and 2017.
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
- adult patients receiving allogeneic hematopoietic stem cell transplantation for myelofibrosis in five centers in France (Nancy, Besançon, Strasbourg, Pitié Salpètrière and Lyon) between 2007 and 2017
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- age < 18 years old
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
Time frame: at 1 year
incidence of survival in the cohort
3 secondary outcomes
incidence of relapse
Time frame: at 1 year
incidence of acute graft versus host disease
Time frame: at 3 months
incidence of chronic graft versus host disease
Time frame: at 1 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 12 Mar 2020.
- Background: PubMed 28389256Kroger N, Panagiota V, Badbaran A, Zabelina T, Triviai I, Araujo Cruz MM, Shahswar R, Ayuk F, Gehlhaar M, Wolschke C, Bollin R, Walter C, Dugas M, Wiehlmann L, Lehmann U, Koenecke C, Chaturvedi A, Alchalby H, Stadler M, Eder M, Christopeit M, Gohring G, Koenigsmann M, Schlegelberger B, Kreipe HH, Ganser A, Stocking C, Fehse B, Thol F, Heuser M. Impact of Molecular Genetics on Outcome in Myelofibrosis Patients after Allogeneic Stem Cell Transplantation. Biol Blood Marrow Transplant. 2017 Jul;23(7):1095-1101. doi: 10.1016/j.bbmt.2017.03.034. Epub 2017 Apr 4.
- Background: PubMed 26708839Hussein K, Stucki-Koch A, Alchalby H, Triviai I, Kroger N, Kreipe H. Cytokine Expression Pattern in Bone Marrow Microenvironment after Allogeneic Stem Cell Transplantation in Primary Myelofibrosis. Biol Blood Marrow Transplant. 2016 Apr;22(4):644-650. doi: 10.1016/j.bbmt.2015.12.006. Epub 2015 Dec 19.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Myelofibrosis, run by Central Hospital, Nancy, 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 0 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 12 Mar 2020. 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?
survival (time frame: at 1 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 NCT04282421, which also lists 2 linked publications.
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 12 Mar 2020.