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

Completed

• Conditions: Myelodysplasia

• Registration Number: NCT01095874
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2010-03-29
• Study First Submitted QC: 2010-03-29
• Study First Posted: 2010-03-30
• Status Verified: 2014-01
• Primary Completion: 2014-01
• Last Update Submitted: 2014-01-17
• Last Update Posted: 2014-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 164

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
overall survival in patient with or without donor	36 months

Trial Locations

Locations (1)

Hôpital Saint-Louis; 🇫🇷 Paris Cedex 10, France