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

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.

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Key information

Conditions

Myelodysplasia Anemia Anemia, Refractory Anemia, Refractory, with Excess of Blasts Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases Myelodysplastic Syndromes

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Saint-Louis

Paris, 75475, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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%

Treatment and study plan

Primary outcomes

overall survival in patient with or without donor

Time frame: 36 months

Sponsors and collaborators

Lead sponsor

Saint-Louis Hospital, Paris, France

Other

Collaborators

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

Registry information

Official study 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

Acronym: ONIalloMDS

Important dates

Study start: 2008
Primary completion: 2014
First posted: Mar 30, 2010
Registry last updated: Jan 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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