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Allogeneic Hematopoietic Stem Cell Transplantation Evaluation in High Risk Myelodysplasia: an Observational Non-interventional Study (ONIalloMDS)

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ClinicalTrials.gov Identifier: NCT01095874
Recruitment Status : Completed
First Posted : March 30, 2010
Last Update Posted : January 20, 2014
Sponsor:
Collaborators:
Hospital Avicenne
University Hospital, Grenoble
University Hospital, Clermont-Ferrand
Information provided by (Responsible Party):
Marie Robin, Saint-Louis Hospital, Paris, France

Brief 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. Patients are registered when they acquire risk factors.

Condition or disease
Myelodysplasia

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Study Type : Observational
Actual Enrollment : 164 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Study Start Date : January 2008
Actual Primary Completion Date : January 2014

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. overall survival in patient with or without donor [ Time Frame: 36 months ]


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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients from 50 to 70 years with high risk myelodysplasia and eligible for transplantation
Criteria

Inclusion Criteria:

  • 50 to 70 years
  • For myelodysplasia other than CMML: patients can be included if they have at least one of these criteria:

    1. IPSSintermediate 1 and poor cytogenetics (complex, 3 or 7 abnormality);
    2. thrombopenia < 20x10ex9/L:
    3. IPSS intermediate 2 or high
  • For CMML: patients can be included if they have at least one of these criteria:

    1. 2 of these criteria: hyperleucocytosis > 10x10exp9/L, splenomegaly>18cm, hemoglobin < 10gr/dl, platelet < 100x10ex9/L
    2. IPSS intermediate 2 or high

Exclusion Criteria:

  • 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%

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01095874


Locations
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France
Hôpital Saint-Louis
Paris Cedex 10, France, 75475
Sponsors and Collaborators
Saint-Louis Hospital, Paris, France
Hospital Avicenne
University Hospital, Grenoble
University Hospital, Clermont-Ferrand

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Responsible Party: Marie Robin, Dr Marie Robin, Saint-Louis Hospital, Paris, France
ClinicalTrials.gov Identifier: NCT01095874     History of Changes
Other Study ID Numbers: AGRAAH 08-01
First Posted: March 30, 2010    Key Record Dates
Last Update Posted: January 20, 2014
Last Verified: January 2014

Keywords provided by Marie Robin, Saint-Louis Hospital, Paris, France:
myelodysplasia
allogeneic hematopoietic stem cell transplantation
Survival
Transplantation

Additional relevant MeSH terms:
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Myelodysplastic Syndromes
Preleukemia
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms