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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01095874

Acronym

ONIalloMDS

Enrollment

164

Registered

2010-03-30

Start date

2008-01-31

Completion date

Unknown

Last updated

2014-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myelodysplasia

Keywords

myelodysplasia, allogeneic hematopoietic stem cell transplantation, Survival, Transplantation

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

50 Years to 70 Years

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: 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%

Design outcomes

Primary

Measure	Time frame
overall survival in patient with or without donor	36 months

Countries

France

Outcome results