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Allogeneic Stem Cell Transplantation for Patients with Severe Aplastic Anemia

Overview

Información sobre este estudio

For patients with severe aplastic anemia (SAA) who have failed to respond to immunosuppressive therapy and lack an HLA identical family member, our objectives are to make an initial assessment of the safety and efficacy of allogenic stem cell transplantation from either a matched unrelated donor or a mismatched reacted donor using the conditioning regimen of Cytoxan, reduced total body irradiation (TBI) and Campath IH. The principle measures of safety and efficacy will be :

  1. Patient survival probability at 100 days, 1 year and 2 years.
  2. Incidence of graft versus host disease (GVHD), as well as incidence of acute GVHD and chronic GVHD within 6 months and 2 years.
  3. Engraftment at 6 months, 1 year and 2 years

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion Criteria:

  • Diagnosis of SAA based on bone marrow aspirate and biopsy results
  • Failure to respond to immunosuppressive therapy
  • Lack of an HLA identical family member
  • A 6/6 or 5/6 HLA matched unrelated donor or a 5/6 matched related donor available after high resolution typing

Exclusion Criteria:

  • Aplastic anemia and active infection must be treated to maximally resolve this problem before beginning the conditioning regimen
  • HIV seropositive
  • Clonal cytogenetic abnormalities or a myelodysplastic syndrome
  • Greater than 60 years of age
  • Pregnant or nursing
  • Active hepatitis
  • Severe cardiac dysfunction defined as shortening fraction <25%
  • Severe renal dysfunction defined as creatinine clearance < 40ml/mim/1.73m2
  • Severe pulmonary dysfunction with FEV1, FVC and DLCO 40% of predicted or 3 SD below normal

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus

Rochester, Minn.

Investigador principal de Mayo Clinic

Shakila Khan, M.D.

Cerrado para la inscripción

More information

Publicaciones

Publications are currently not available

Otros temas en investigación

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CLS-20128849

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