ALLOGENEIC MARROW OR PERIPHERAL BLOOD STEM CELL TRANSPLANTATION FOR AGNOGENIC MYELOID METAPLASIA WITH MYELOFIBROSIS
busulfan
+ cyclophosphamide
+ cyclosporine
Troubles de la coagulation sanguine+21
+ Troubles des Plaquettes Sanguines
+ Maladies de la moelle osseuse
Étude thérapeutique
Résumé
Date de début de l'étude : 1 juin 1996
Date à laquelle le premier participant a commencé l'étude.OBJECTIVES: Assess disease free survival in patients with idiopathic myelofibrosis treated with a preparative busulfan/cyclophosphamide regimen followed by allogeneic bone marrow or peripheral blood stem cell transplantation. Determine the risk of primary graft failure in these patients. OUTLINE: Patients receive a preparative regimen consisting of oral busulfan every 6 hours on days -7 through -4 and cyclophosphamide on days -3 and -2. Patients then receive allogeneic bone marrow or peripheral blood stem cells on day 0. Patients registered on protocol FHCRC-1106.00 randomized to stem cell transplant receive unmodified G-CSF-mobilized stem cells from an HLA-identical donor. Patients receive cyclosporine/methotrexate or tacrolimus/methotrexate as prophylaxis for graft-versus-host disease (GVHD). Patients receiving marrow from unrelated donors are eligible for appropriate GVHD prophylaxis studies. Patients are followed at 6 and 12 months after transplant. PROJECTED ACCRUAL: A maximum of 20 patients will be accrued for this study over approximately 3.5 years.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.20 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.Jusqu'à 65 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
DISEASE CHARACTERISTICS: Idiopathic myelofibrosis (IMF) with at least 1 poor prognosis characteristic, including but not limited to: Hemoglobin less than 10 g/dL Platelet count less than 100,000/mm^3 Hepatomegaly (i.e., palpable liver edge 5 cm below costal margin) Clinical requirement for splenectomy Other myeloproliferative disorders in an IMF like myelofibrotic state eligible No evidence of leukemic progression, e.g.: Greater than 15% peripheral blood blasts Fever or bone pain of unknown origin Rapidly progressing splenomegaly No other causes for myelofibrosis, such as: Collagen vascular disorder Lymphoma Granulomatous infection Metastatic carcinoma Hairy cell leukemia Myelodysplastic syndrome No active central nervous system disease One of the following donor/patient pairings is required: Donor status: Genotypic or phenotypic HLA-matched relative Maximum patient age of 65 One antigen HLA-mismatched relative, HLA-matched unrelated donor, or one antigen HLA-mismatched unrelated donor Maximum patient age of 55 Transplant on this protocol allowed for patients registered on protocol FHCRC-1106.00 PATIENT CHARACTERISTICS: Age: 65 and under Performance status: Not specified Hematopoietic: See Disease Characteristics Hepatic: Bilirubin no greater than 2 times normal SGPT no greater than 4 times normal Renal: Creatinine no greater than two times normal OR Creatinine clearance at least 50% Cardiovascular: Ejection fraction at least 50% Cardiac evaluation required if signs or symptoms of coronary artery disease or congestive heart failure Other: HIV negative No active infection Patients excluded from this protocol are referred to protocol FHCRC-179.05 PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site
Fred Hutchinson Cancer Research Center
Seattle, United StatesOuvrir Fred Hutchinson Cancer Research Center dans Google Maps