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

January 17, 2014 updated by: Marie Robin, Saint-Louis Hospital, Paris, France

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

164

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris Cedex 10, France, 75475
        • Hôpital Saint-Louis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients from 50 to 70 years with high risk myelodysplasia and eligible for transplantation

Description

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%

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
overall survival in patient with or without donor
Time Frame: 36 months
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saint-Louis Hospital, Paris, France

Collaborators

University Hospital, Clermont-Ferrand
University Hospital, Grenoble
Hospital Avicenne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

March 29, 2010

First Submitted That Met QC Criteria

March 29, 2010

First Posted (Estimate)

March 30, 2010

Study Record Updates

Last Update Posted (Estimate)

January 20, 2014

Last Update Submitted That Met QC Criteria

January 17, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AGRAAH 08-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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