A Randomized Trial of Antithymocyte Globulin Versus Cyclosporine to Treat the Cytopenia of Myelodysplastic Syndrome
Antithymocyte globulin
+ Cyclosporine
Maladies de la moelle osseuse+2
+ Maladies hématologiques et lymphatiques
+ Anémie
Étude thérapeutique
Résumé
Date de début de l'étude : 1 décembre 1998
Date à laquelle le premier participant a commencé l'étude.Approximately 40% of the patients with myelodysplastic syndrome (MDS) die as a consequence of their cytopenia. As in aplastic anemia, the cytopenia of MDS may be partly due to cytotoxic T cell activity. Immunosuppressive therapy may therefore reverse the cytopenia. In a phase II pilot study of anti-thymocyte globulin (ATG) to treat myelodysplastic syndrome (MDS); 41% of patients (61% of patients with refractory anemia) have responded in terms of transfusion independence. Recently, Jonasova et al [32] reported a 82% substantial hematological response rate in 18 patients with MDS of the refractory anemia (RA) subtype treated with cyclosporine alone. Just over 50% of the patients in this series had MDS of the hypocellular type. Cyclosporine alone if indeed efficacious would be a powerful therapeutic option that could be readily used by hematologists in the community to treat patients with MDS. This efficacy needs to be proven in a larger study which includes patients with the other subtypes of MDS and more patients with the non-hypocellular forms of MDS (which constitute approximately 70% of the cases in the community). As MDS is a heterogeneous group of disorders, a randomized comparison with the other immunomodulating intervention of proven benefit, ATG, is appropriate. In this randomized study patients with MDS will receive either ATG alone or cyclosporine alone.
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.182 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.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
MDS of RA & RAEB sub-types. No current treatment and off other treatments for at least two weeks. ECOG performance status less than or equal to 2. No MDS of FAB sub-group' refractory anemia with ring sideroblasts' (RARS). No transforming to acute leukemia (FAB sub-group RAEB-Tie.; greater than 20% blasts in marrow aspirate). No hypoplastic marrow without one major or two minor criteria as outlined in table 3 of the appendix. No one being treatment with growth factors or cyclosporine within four weeks prior to entry to protocol. No previous treatment with ATG. No ECOG performance status of greater than 2. No active uncontrolled infection. No women which current pregnancy, or unwilling to take oral contraceptives if of childbearing potential. No patients for whom bone marrow transplant is indicated as primary therapy. No one age less than 18 years. Must be able to give informed consent. No HIV positive patients. No active malignant disease (excluding basal cell carcinoma). No one with serum creatine greater than 2mg/dl. No patients who are moribund or patients with concurrent hepatic, renal, cardiac, metabolic, or any disease of such severity that death within 7-10 days is likely.
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
Warren G. Magnuson Clinical Center (CC)
Bethesda, United StatesOuvrir Warren G. Magnuson Clinical Center (CC) dans Google Maps