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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


N/A
50 Years
70 Years
Open (Enrolling)
Both
Myelodysplasia

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Trial Information

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


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%

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Authority:

France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé

Study ID:

AGRAAH 08-01

NCT ID:

NCT01095874

Start Date:

January 2008

Completion Date:

Related Keywords:

  • Myelodysplasia
  • myelodysplasia
  • allogeneic hematopoietic stem cell transplantation
  • Survival
  • Transplantation
  • Myelodysplastic Syndromes
  • Preleukemia

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