Spots Global Cancer Trial Database for Treatment of MDS/AML Patients With an Impending Hematological Relapse With AZA or ATA and Pevonedistat
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: Treatment of MDS/AML Patients With an Impending Hematological Relapse With AZA or ATA and Pevonedistat
Official Title: Treatment of MDS/AML Patients With an Impending Hematological Relapse With Azacitidine Alone or in Combination With PEvonedistat - a Randomized Phase 2 Trial
Study ID: NCT04712942
Study Description
Brief Summary: MDS/AML with MRD and impending relapse after allogeneic stem cell transplantation and/or conventional chemotherapy
Detailed Description: Experimental arm: pevonedistat in combination with azacitidine Control arm: azacitidine alone With the following modifications: * Patients on the azacitidine arm and still MRD+ at 3 months but without hematological relapse can cross over to the combination arm * Cross over into the combination arm is possible any time up to 9 months of study treatment if initially responding patients (at 3 months) on AZA monotherapy become MRD positive again * Maximum treatment duration of 1 year * Patients receive pevonedistat at 20 mg/m2 i.v. (d1,3,5, q4w); azacitidine is given at a standard dose of 75 mg/m² i.v. or s.c. (d1-7 or 1-5,8,9, q4w)
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Medizinische Klinik IV - Hämatologie und Onkologie, Universitätsklinikum Aachen, Aachen, , Germany
Zentrum Hämatologie, Onkologie, Palliativmedizin, Helios Klinikum Berlin-Buch GmbH, Berlin, , Germany
Klinik fßr Innere Medizin III, Hämatologie, Onkologie, Stammzelltransplantation, Klinikum Chemnitz gGmbH, Chemnitz, , Germany
Hämatologie/Internistische Onkologie, Onkologische Tagesklinik, Cottbus, , Germany
Medizinischen Klinik und Poliklinik I / Hämatologie, Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden, Dresden, , Germany
Klinik fßr Hämatologie, Universitätsklinikum Essen, Essen, , Germany
Universitätsklinik und Poliklinik fßr Innere Medizin IV, Onkologie, Hämatologie, Universitätsklinikum Halle (Saale), Halle (Saale), , Germany
Klinik und Poliklinik fßr Innere Medizin II/Hämat. - Onkologie, Universitätsklinikum Jena, Jena, , Germany
Klinik fßr Innere Medizin II/ Hämatologie und Onkologie, Univ.Klinikum Schleswig-Holstein/Campus Kiel, Kiel, , Germany
Medizinische Klinik und Poliklinik I - Hämatologie und Zelltherapie, Hämostaseologie, Leipzig University, Leipzig, , Germany
Innere Medizin A/Hämatologie-Onkologie, Universitätsklinik Mßnster, Mßnster, , Germany
Klinik fßr Hämatologie, Onkologie & Stammzelltherapie, Helios-Klinikum Schwerin, Schwerin, , Germany
Klinik Innere Medizin III - Onko-, Häma- u. Palliativmedizin, Diakonie-Klinikum Schwäbisch Hall gGmbH, Schwäbisch Hall, , Germany
Abteilung fßr Hämatologie, Onkologie und Palliativmedizin, Robert-Bosch-Krankenhaus Stuttgart, Stuttgart, , Germany
Contact Details
Name: Uwe Platzbecker, Prof. Dr.
Affiliation: University Leipzig
Role: PRINCIPAL_INVESTIGATOR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
