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

Myelodysplasia Clinical Trial

— ONIalloMDS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01095874
• Other study ID #: AGRAAH 08-01
• Status: Completed
• Phase: N/A
• First received: March 29, 2010
• Last updated: January 17, 2014
• Start date: January 2008

Study information

• Verified date: January 2014
• Source: Saint-Louis Hospital, Paris, France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
• Study type: Observational

Clinical 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. Patients are registered when they acquire risk factors.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 164
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 70 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Myelodysplasia
• Myelodysplastic Syndromes
• Preleukemia

Locations

Country	Name	City	State
France	Hôpital Saint-Louis	Paris Cedex 10

Sponsors (4)

Lead Sponsor	Collaborator
Saint-Louis Hospital, Paris, France	Hospital Avicenne, University Hospital, Clermont-Ferrand, University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival in patient with or without donor		36 months	No