The Use Of Umbilical Cord Blood As A Source Of Hematopoietic Stem Cells
anti-thymocyte globulin
+ cyclophosphamide
+ radiation therapy
Étude thérapeutique
Résumé
Date de début de l'étude : 1 septembre 2003
Date à laquelle le premier participant a commencé l'étude.OBJECTIVES: Primary * Determine the impact of the use of umbilical cord blood as a source of hematopoietic stem cells for children with life-threatening oncologic, hematologic, or genetic/metabolic disorders in need of a stem cell transplant. * Compare the incidence of graft-versus-host disease in patients receiving cord blood transplants in this study with historical data for unrelated donor stem cell transplants. * Compare the incidence of engraftment in patients receiving cord blood transplants in this study with historical data for unrelated donor stem cell transplants. OUTLINE: * Preparative therapy: Patients are treated on 1 of 4 preparative therapy regimens. * Regimen A: Patients undergo total body irradiation (TBI) two times daily on days -7 to -4. Patients receive cyclophosphamide IV over 30-60 minutes on days -3 and -2 and anti-thymocyte globulin (ATG) IV over at least 6 hours on days -3 to -1. * Regimen B (patients who do not receive TBI): Patients receive oral busulfan 4 times daily on days -8 to -5, and ATG IV over at least 6 hours and melphalan IV over 15-20 minutes on days -4 to -2. * Regimen C (patients with Fanconi's anemia and related disorders): Patients undergo TBI on day -6. Patients receive ATG IV over at least 6 hours and methylprednisolone IV on days -5 to -1 and fludarabine IV over 30 minutes and cyclophosphamide IV over 30-60 minutes on days -5 to -2. * Regimen D: Patients receive oral or IV busulfan 4 times daily on days -9 to -5, ATG IV over at least 6 hours on days -5 to -3, and cyclophosphamide IV over 30-60 minutes on days -5 to -2. * Cord blood transplant: All patients undergo umbilical cord blood transplantation on day 0. * Graft-versus-host disease prophylaxis: Patients receive oral or IV cyclosporine twice daily beginning on day -1. Patients also receive methylprednisolone IV twice daily beginning on day 5 and continuing until at least day 28. PROJECTED ACCRUAL: A total of 25 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.25 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 21 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.Critères
DISEASE CHARACTERISTICS: * Diagnosis of malignant or non-malignant disease, including but not limited to any of the following: * Acute myeloid leukemia or acute lymphoblastic leukemia (ALL) with resistant disease beyond first clinical remission (CR) * ALL in first CR at high-risk because of 1 of the following factors: * Hypoploidy * Pseudodiploidy with translocations t(9;22), t(4;11), or t(8;14) * Elevated WBC at diagnosis as follows: * \> 100,000/mm\^3 for patients 6-12 months of age * \> 50,000/mm\^3 for patients 10-20 years of age * \> 20,000/mm\^3 for patients 21 years of age * Burkitt's lymphoma/leukemia * Chronic myelogenous leukemia in first chronic phase or beyond * Juvenile myelomonocytic leukemia * Advanced stage or relapsed lymphoma * Advanced stage or relapsed solid tumors, including any of the following: * Neuroblastoma * Ewing's sarcoma * Rhabdomyosarcoma * Myelodysplastic syndromes, excluding patients with grade 3 or 4 myelofibrosis * Familial erythrophagocytic histiocytosis * Histiocytosis unresponsive to medical management * Inborn errors of metabolism * Langerhans cell histiocytosis unresponsive to medical management * Immune deficiencies, including: * Severe combined immune deficiency * Wiskott-Aldrich * Hemoglobinopathies, including sickle cell disease and thalassemia * Severe aplastic anemia * Fanconi's anemia * Metabolic storage diseases * Unrelated cord blood donor must be HLA-identical OR may be mismatched for 1, 2, or 3 HLA-loci (A, B, DR) * No other existing HLA-identical related donor available at the time of transplantation PATIENT CHARACTERISTICS: Age * 21 and under Performance status * Not specified Life expectancy * Not specified Hematopoietic * See Disease Characteristics Hepatic * Not specified Renal * Not specified PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.4 groupes d'intervention sont désignés dans cette étude
Cette étude ne comporte pas de groupe placebo.
Groupes de traitement
Groupe I
ExpérimentalGroupe II
ExpérimentalGroupe III
ExpérimentalGroupe IV
ExpérimentalObjectifs de l'étude
Objectifs principaux
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
Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center
Hershey, United StatesVoir le site