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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

164 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-01-31

Brief Summary

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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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Detailed Description

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Conditions

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Myelodysplasia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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%

Minimum Eligible Age

50 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No