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

Sponsor

Saint-Louis Hospital, Paris, France (Other)

Overall Status

Completed

CT.gov ID

NCT01095874

Collaborator

Hospital Avicenne (Other), University Hospital, Grenoble (Other), University Hospital, Clermont-Ferrand (Other)

164

Enrollment

Location

Study Details

Study Description

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	Intervention/Treatment	Phase
Myelodysplasia

Study Design

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 :

Jan 1, 2008

Actual Primary Completion Date :

Jan 1, 2014

Outcome Measures

Primary Outcome Measures

overall survival in patient with or without donor [36 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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%