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

Paris Hospitals Public Assistance (APHP)

Status: Completed

Conditions: Myelodysplasia

Study type: Observational

Funder types: Other

Identifiers

NCT01095874

AGRAAH 08-01

Details and patient eligibility

About

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.

Enrollment: 164 patients

Sex: All

Ages: 50 to 70 years old

Volunteers: No 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%