HIGH-DOSE CHEMOTHERAPY FOLLOWED BY AUTOLOGOUS PERIPHERAL BLOOD STEM CELL TRANSPLANTATION FOR CHILDREN WITH RELAPSED ACUTE LYMPHOCYTIC LEUKEMIA
filgrastim
+ sargramostim
+ carmustine
Maladies Hématologiques+8
+ Maladies hématologiques et lymphatiques
+ Maladies du Système Immunitaire
Étude thérapeutique
Résumé
Date de début de l'étude : 1 mars 1995
Date à laquelle le premier participant a commencé l'étude.OBJECTIVES: Determine the efficacy of autologous peripheral blood stem cell (PBSC) transplantation for marrow reconstitution after high-dose carmustine, cytarabine, etoposide, and cyclophosphamide in children with relapsed acute lymphocytic leukemia. Determine the dose effect of autologous PBSC on engraftment in this patient population. OUTLINE: Patients receive chemotherapy mobilization comprising cytarabine IV every 12 hours on days 1-5. When blood counts recover, autologous peripheral blood stem cells (PBSC) are harvested and selected for mononuclear cells, granulocyte-macrophage colony-forming units, and CD34+ cells. Patients receive preparative regimen comprising carmustine IV on days -8 and -3, cytarabine IV every 12 hours and etoposide IV every 12 hours on days -7 to -4, and cyclophosphamide IV on days -2 and -1. PBSC are reinfused on day 0. Patients receive filgrastim (G-CSF) or sargramostim (GM-CSF) beginning after PBSC transplantation. Male patients undergo radiotherapy to the testes before transplantation. Patients with a history of CNS leukemia undergo craniospinal irradiation before transplantation. Patients are followed at 100 days, 6 months, and 1 year. PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study within 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.30 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 1 à 19 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: Diagnosis of acute lymphoblastic leukemia Pathologic evidence of relapse in marrow, CNS, or testes In second or later complete remission Ineligible for allogeneic transplantation: No suitable allogeneic donor (sibling or family donor or unrelated donor with no more than 1 HLA-A or -B antigen mismatch and HLA-DR identical) OR Ineligible for preparative regimen including total-body irradiation Peripheral blood stem cell collection feasible: Patient size generally at least 8 kg Able to place central venous catheter Patient cooperative PATIENT CHARACTERISTICS: Age: 1 to 19 Performance status: Not moribund Life expectancy: No severe limits from disease other than leukemia Hepatic: Bilirubin no greater than 3 times normal for age AST and/or GGT no greater than 3 times normal for age No evidence of hepatic synthetic dysfunction Renal: GFR at least 50% of normal based on Glofil study or 12-hour creatinine clearance Cardiovascular: Cardiac contractility normal on echocardiogram Pulmonary: FVC and FEV_1 with or without DLCO at least 50% predicted Other: No significant active infection HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy See Disease Characteristics Chemotherapy See Disease Characteristics Endocrine therapy Not specified Radiotherapy See Disease Characteristics 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
University of Nebraska Medical Center
Omaha, United StatesOuvrir University of Nebraska Medical Center dans Google Maps