MyelodysplasiaONIalloMDSNCT01095874
Allogeneic Hematopoietic Stem Cell Transplantation Evaluation in High Risk Myelodysplasia: an Observational Non-interventional Study
An observational study of Myelodysplasia, run by Saint-Louis Hospital, Paris, France at 1 site in France.
Trial summary
The purpose of this study is to compare outcome of high risk myelodysplasia patients aged from 50 to 70 years with or without HLA compatible (9 or 10 identities / 10) donor. High risk myelodysplasia includes IPSS intermediate 2 and high myelodysplasia and patients with sever thrombocytopenia. Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Myelodysplasia
- How many people
- 164 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2008to Jan 2014
- 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 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients from 50 to 70 years with high risk myelodysplasia and eligible for transplantation
Who may be able to join
- 50 to 70 years
- For myelodysplasia other than CMML: patients can be included if they have at least one of these criteria:
- IPSSintermediate 1 and poor cytogenetics (complex, 3 or 7 abnormality);
- thrombopenia < 20x10ex9/L:
- IPSS intermediate 2 or high
- For CMML: patients can be included if they have at least one of these criteria:
- 2 of these criteria: hyperleucocytosis > 10x10exp9/L, splenomegaly>18cm, hemoglobin < 10gr/dl, platelet < 100x10ex9/L
- IPSS intermediate 2 or high
Who cannot join
- Patient not eligible for transplantation (including patients without donor)because of severe co-morbidity including:
- Renal failure with creatinine clearance < 30ml/min
- Cirrhosis or hepatic failure
- Respiratory disease with vital capacity < 30%
- Uncontrolled cardiac failure
- Uncontrolled neurological disease
- Poor performance status with karnofsky < or = 60%
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Allogeneic Hematopoietic Stem Cell Transplantation Evaluation in High Risk Myelodysplasia: an Observational Non-interventional Study Comparing Outcome of Patients Aged From 50 to 70 Years With or Without Donor
The purpose of this study is to compare outcome of high risk myelodysplasia patients aged from 50 to 70 years with or without HLA compatible (9 or 10 identities / 10) donor. High risk myelodysplasia includes IPSS intermediate 2 and high myelodysplasia and patients with sever thrombocytopenia. Patients are registered when they acquire risk factors.
- Conditions
- Myelodysplasia
- Keywords
- myelodysplasia, allogeneic hematopoietic stem cell transplantation, Survival, Transplantation
- Medical subject headings
- Anemia, Refractory, with Excess of Blasts
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival in patient with or without donor
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2010 (estimated)
- Study startJan 2008
- Primary completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyelodysplasiaStudies 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
- Prospective
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint-Louis Hospital, Paris, France
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Avicenne, University Hospital, Grenoble, University Hospital, Clermont-Ferrand
- Responsible party
- Principal investigator, Marie Robin, Saint-Louis Hospital, Paris, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01095874
- Sponsor's protocol ID
- AGRAAH 08-01
- Acronym
- ONIalloMDS
- Status last verified
- Jan 2014
- First submitted
- 29 Mar 2010
- Last updated
- 20 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allogeneic Hematopoietic Stem Cell Transplantation Evaluation in High Risk Myelodysplasia: an Observational Non-interventional Study Comparing Outcome of Patients Aged From 50 to 70 Years With or Without Donor
- ClinicalTrials.gov ID
- NCT01095874
- Acronym / sponsor ID
- ONIalloMDS / AGRAAH 08-01
- Conditions
- Myelodysplasia
- Keywords
- myelodysplasia, allogeneic hematopoietic stem cell transplantation, Survival, Transplantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Saint-Louis Hospital, Paris, FranceUniversity, hospital or other
- Collaborators
- Hospital Avicenne, University Hospital, Grenoble, University Hospital, Clermont-Ferrand
- Study start
- Jan 2008
- Primary completion
- Jan 2014 (actual)
- First posted
- 30 Mar 2010 (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.
The purpose of this study is to compare outcome of high risk myelodysplasia patients aged from 50 to 70 years with or without HLA compatible (9 or 10 identities / 10) donor. High risk myelodysplasia includes IPSS intermediate 2 and high myelodysplasia and patients with sever thrombocytopenia. Patients are registered when they acquire risk factors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from 50 to 70 years with high risk myelodysplasia and eligible for transplantation
Key inclusion criteria (8 listed)
- 50 to 70 years
- For myelodysplasia other than CMML: patients can be included if they have at least one of these criteria:
- For CMML: patients can be included if they have at least one of these criteria:
Key exclusion criteria (7 listed)
- Patient not eligible for transplantation (including patients without donor)because of severe co-morbidity including:
- Renal failure with creatinine clearance < 30ml/min
- Cirrhosis or hepatic failure
- Respiratory disease with vital capacity < 30%
- Uncontrolled cardiac failure
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 in patient with or without donor
Time frame: 36 months
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 20 Jan 2014.
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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.
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 Myelodysplasia, run by Saint-Louis Hospital, Paris, France 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 8 inclusion and 7 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 20 Jan 2014. 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?
overall survival in patient with or without donor (time frame: 36 months). 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 20 Jan 2014.