A Phase III Study of Flt3 Ligand (Flt3L) Therapy in Acute Myeloid Leukemia (AML) Patients in Remission
Collecte de données
Maladies de la moelle osseuse+11
+ Leucémie érythroblastique aiguë
+ Maladies Hématologiques
Étude thérapeutique
Résumé
Date de début de l'étude : 1 juillet 2000
Date à laquelle le premier participant a commencé l'étude.OBJECTIVES: * Compare the failure-free survival and overall survival in patients with acute myeloid leukemia in complete remission treated with maintenance flt3 ligand vs observation alone. * Compare the long-term immunologic effects of these regimens in these patients. * Compare the long-term safety and toxicity of these regimens in these patients. OUTLINE: This is a randomized study. Patients are stratified according to complete remission (CR) (first vs second vs third or subsequent) and post-remission therapy (yes vs no). Patients are randomized to one of two treatment arms. * Arm I: Patients receive flt3 ligand subcutaneously daily on days 1-14. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. * Arm II: Patients undergo observation alone. Patients begin treatment or observation within 4 weeks after documentation of CR after induction therapy or within 4 weeks after discharge from hospital after post-remission therapy. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 139 patients will be accrued for this study within approximately 28 months.
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.À partir de 18 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 myeloid leukemia in first, second, third, or subsequent complete remission (CR) * Must be at least 60 years of age if first CR * Must have had histological proof (from bone marrow aspirate, smears, or touch preps of marrow biopsy) of one of the following prior to achieving CR: * Acute myeloblastic leukemia (M0, M1, M2) * Acute promyelocytic leukemia (M3) * Acute myelomonocytic leukemia (M4) * Acute monocytic leukemia (M5) * Acute erythroleukemia (M6) * Acute megakaryocytic leukemia (M7) * Refractory anemia with excess blasts in transformation PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Bilirubin less than 3 times upper limit of normal (ULN) * SGOT less than 3 times ULN Renal: * Creatinine less than 2 mg/dL Cardiovascular: * No clinically significant active cardiac disease Pulmonary: * No clinically significant active pulmonary disease Other: * Not pregnant or nursing * Fertile patients must use effective contraception * No uncontrolled or active autoimmune disease PRIOR CONCURRENT THERAPY: Biologic therapy: * Prior autologous bone marrow transplantation (BMT) allowed * No prior allogeneic BMT * Other prior immunotherapy allowed if not received during the most recent treatment 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 47 sites
Veterans Affairs Medical Center - Birmingham
Birmingham, United StatesOuvrir Veterans Affairs Medical Center - Birmingham dans Google MapsUniversity of California San Diego Cancer Center
La Jolla, United StatesVeterans Affairs Medical Center - San Francisco
San Francisco, United StatesUCSF Cancer Center and Cancer Research Institute
San Francisco, United States