Unrelated Bone Marrow Transplantation With Cyclophosphamide and Total Body Irradiation For Hematologic Malignancies and Bone Marrow Failure States
anti-thymocyte globulin
+ filgrastim
+ sargramostim
Anémie+29
+ Maladies de la moelle osseuse
+ Maladie chronique
Étude thérapeutique
Résumé
Date de début de l'étude : 1 août 1996
Date à laquelle le premier participant a commencé l'étude.OBJECTIVES: Study the curative potential of high-dose cyclophosphamide and total-body irradiation followed by rescue with bone marrow from volunteer HLA-matched donors in patients with a variety of hematologic malignancies and bone marrow failure states. Study the toxic effects associated with matched unrelated bone marrow transplantation in this patient population. Participate in collaborative research studies with the National Marrow Donor Program. OUTLINE: All patients receive myeloablative therapy with high-dose cyclophosphamide and total body irradiation over 4 days; patients with severe aplastic anemia also receive antithymocyte globulin. Patients then undergo allogeneic bone marrow transplantation. Filgrastim (G-CSF) is given after transplant to accelerate engraftment. Sargramostim (GM-CSF) may be given in case of graft failure. All patients receive graft-versus-host-disease (GVHD) prophylaxis with tacrolimus, methotrexate, and gamma globulin. Established GVHD is treated with corticosteroids and, as necessary, antithymocyte globulin. Patients are followed at 100 days, 6 months, and 1 year after transplant, then annually thereafter. PROJECTED ACCRUAL: A total of 10 patients per year will be accrued for this study over 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.10 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.De 17 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: One of the following hematologic malignancies/disorders: Acute lymphoblastic leukemia In second or subsequent complete remission (CR) In first CR with high-risk features (e.g., Philadelphia chromosome-positive) In first relapse and failed conventional salvage therapy Acute myelogenous leukemia (AML) In second or subsequent CR In early first relapse In full first relapse and failed conventional salvage therapy In first CR with high-risk features, e.g., trisomy 8 or FAB 6/7 Standard-risk AML offered conventional-dose consolidation chemotherapy or autologous bone marrow transplantation Chronic myelogenous leukemia in chronic, accelerated, or second chronic phase No blast crisis Severe aplastic anemia that has failed at least 1 course of immunosuppressive therapy Paroxysmal nocturnal hemoglobinuria with high-risk features (e.g., disseminated intravascular coagulation, thrombotic events) Myelodysplastic syndrome, i.e.: Symptomatic, transfusion-dependent refractory anemia with excess blasts (RAEB) or RAEB in transformation Secondary leukemia in CR following conventional-dose induction chemotherapy Unrelated marrow donor available who is 8 out of 10-, 9 out of 10-, or 10 out of 10-antigen serologically HLA-matched at A, B, C, DRb, and DQB loci by molecular typing No CNS malignancy PATIENT CHARACTERISTICS: Age: 17 to 60 Performance status: Karnofsky 70-100% Life expectancy: No reduction due to other serious illness Hematopoietic: Not specified Hepatic: Bilirubin less than 3 mg/dL AST/ALT no greater than twice normal Renal: Creatinine no greater than 2.0 mg/dL Creatinine clearance greater than 60 mL/min Cardiovascular: Left ventricular ejection fraction at least 45% No severe hypertension Pulmonary: DLCO, FEV_1, and FVC at least 50% Other: HIV negative No active infection at time of transplant No advanced diabetes No significant neurologic deficit No active drug or substance abuse No emotional disorders Able to participate in frequent medical care for at least 1-2 years Willing to comply with National Marrow Donor Program policies PRIOR CONCURRENT THERAPY: Biologic therapy See Disease Characteristics Chemotherapy See Disease Characteristics 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
Fox Chase-Temple Cancer Center
Philadelphia, United StatesOuvrir Fox Chase-Temple Cancer Center dans Google Maps