Phase II Study of High-Dose Busulfan and Cyclophosphamide Followed by Allogeneic Bone Marrow Transplantation for Patients With Acute Myelogenous Leukemia
busulfan
+ cyclophosphamide
+ allogeneic bone marrow transplantation
Anémie+24
+ Maladies de la moelle osseuse
+ Maladie chronique
Étude thérapeutique
Résumé
Date de début de l'étude : 1 octobre 1999
Date à laquelle le premier participant a commencé l'étude.OBJECTIVES: Determine the remission duration, disease-free survival, and overall survival of patients with acute myelogenous leukemia in remission or early relapse or myelodysplastic syndrome treated with high-dose busulfan and cyclophosphamide followed by allogeneic bone marrow transplantation. OUTLINE: Patients receive oral high-dose busulfan every 6 hours for 14-16 doses on days -9 to -6, followed by high-dose cyclophosphamide IV over 1 hour on days -5 to -2. Allogeneic bone marrow is infused on day 0. Patients who have already had 1 transplant receive high-dose cyclophosphamide IV on days -6 and -5, total body irradiation twice a day on days -4 to -1, and allogeneic bone marrow infusion on day 0. All patients receive prophylaxis for graft versus host disease. Patients are followed every 6 months for at least 2 years. PROJECTED ACCRUAL: A total of 25-40 patients will be accrued for this study.
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.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.De 16 à 60 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: Morphologically proven (from bone marrow aspirate smears or touch preps of marrow biopsy) acute myelogenous leukemia or myelodysplastic syndrome of 1 of the following subtypes: Acute myeloblastic leukemia (M1, M2) Acute promyelocytic leukemia (M3) Acute myelomonocytic leukemia (M4) Acute monocytic leukemia (M5) Acute erythroleukemia (M6) Acute megakaryocytic leukemia (M7) Refractory anemia Refractory anemia with excess blasts Refractory anemia with excess blasts in transformation Refractory anemia with ringed sideroblasts Chronic myelomonocytic leukemia In remission or in early relapse as defined by less than 20% blast cells in the marrow or overt active acute myeloid leukemia Suitable marrow donor, defined as a sibling donor matched at the HLA-A, HLA-B, and HLA-D/DR locus nonreactive in bidirectional mixed lymphocyte culture or a donor who is mismatched at 1 antigen loci Active CNS disease allowed PATIENT CHARACTERISTICS: Age: 16 to physiologic 60 Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 3 times upper limit of normal (ULN) unless due to Gilbert's disease SGOT no greater than 3 times ULN Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: Cardiac ejection fraction normal Pulmonary: FEV_1 at least 50% of predicted DLCO at least 50% of predicted Other: HIV negative No evidence of persistent infection No concurrent organ damage or medical problems that would preclude study therapy PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: No concurrent antibiotics
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
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, United StatesOuvrir Robert H. Lurie Comprehensive Cancer Center at Northwestern University dans Google Maps