Spots Global Cancer Trial Database for Trial of Intensive Chemotherapy With or Without Volasertib in Patients With Newly Diagnosed High-Risk Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML)
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Trial Identification
Brief Title: Trial of Intensive Chemotherapy With or Without Volasertib in Patients With Newly Diagnosed High-Risk Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML)
Official Title: Dose Finding Safety Run-in Phase Followed by a Randomized Phase II Trial of Intensive Chemotherapy With or Without Volasertib (BI 6727) Administered Prior or After Chemotherapy in Patients With Newly Diagnosed High-Risk Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML)
Study ID: NCT02198482
Study Description
Brief Summary: Randomized Phase II Trial of Intensive Chemotherapy With or Without Volasertib (BI 6727) in Patients With Newly Diagnosed High-Risk Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML)
Detailed Description: The trial is a randomized, Phase II, open label multi-center trial in adult patients with newly diagnosed AML or high-risk MDS as defined in the inclusion/exclusion criteria. An initial safety run-in study will be performed administering intensive induction therapy consisting of daunorubicin and cytarabine with the study drug volasertib administered prior or after chemotherapy, as well as consolidation therapy consisting of intermediate-dose cytarabine with the study drug volasertib administered prior or after chemotherapy. After establishing the volasertib dose, the randomized Phase II portion of the trial will begin: Patients will be equally randomized to DA (daunorubicin, cytarabine), V-DA (volasertib administered prior to daunorubicin, cytarabine), and DA-V (volasertib administered after daunorubicin, cytarabine). All patients will receive a second induction cycle with reduced daunorubicin and cytarabine doses. Patients refractory to the first induction cycle and patients not achieving a CR/CRi after two induction cycles will be off-study and followed up. Patients in CR/CRi after induction therapy will proceed to consolidation therapy. Consolidation will be stratified based on the genetic risk profile (according to ELN criteria) and patient-related factors (e.g., age, HCT-CI, comorbidities, patient wish). Patients with a favorable genetic risk profile and those patients considered ineligible for allogeneic HCT will receive repetitive cycles of consolidation according to initial randomization, either MiDAC, V-MiDAC (volasertib administered prior to cytarabine), or MiDAC-V (volasertib administered after cytarabine). All other patients are assigned to allogeneic HCT.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Hospital Aschaffenburg, Aschaffenburg, , Germany
Helios Hospital Bad Saarow, Bad Saarow, , Germany
Vivantes Hospital Am Urban, Berlin, , Germany
Vivantes Hospital Neukölln, Berlin, , Germany
Charite Berlin Campus Virchow Hospital, Berlin, , Germany
Knappschaftskrankenhaus Bochum-Langendeer, Bochum, , Germany
University Hospital Bonn, Bonn, , Germany
Community Hospital Braunschweig, Braunschweig, , Germany
Hospital Darmstadt, Darmstadt, , Germany
University Hospital Düsseldorf, Düsseldorf, , Germany
Hospital Essen, Protestant Hospital Essen-Werden, Essen, , Germany
Hospital Esslingen, Esslingen, , Germany
Malteser Hospital St. Franziskus, Flensburg, , Germany
Hospital Frankfurt-Höchst, Frankfurt, , Germany
Medical Care Unit Osthessen, Fulda, , Germany
University Hospital Gießen, Gießen, , Germany
Wilhelm-Anton-Hospital Goch, Goch, , Germany
University Hospital Göttingen, Göttingen, , Germany
University Hospital Hamburg-Eppendorf, Hamburg, , Germany
Asklepios Hospital Altona, Hamburg, , Germany
Hospital Hanau, Hanau, , Germany
KRH Hospital Siloah-Oststadt-Heidehaus, Hannover, , Germany
Hannover Medical School, Hannover, , Germany
SLK-Hospital Heilbronn, Heilbronn, , Germany
Marienhospital Herne, Herne, , Germany
University Hospital des Saarlandes, Homburg/Saar, , Germany
Community Hospital Karlsruhe, Karlsruhe, , Germany
University Hospital Schleswig-Holstein, Kiel, , Germany
Caritas Hospital Lebach, Lebach, , Germany
Hospital Lippe-Lemgo, Lemgo, , Germany
University Hospital Magdeburg, Magdeburg, , Germany
University Hospital Johannes Gutenberg Mainz, Mainz, , Germany
Johannes Wesling Hospital Minden, Minden, , Germany
Stauferklinikum Schwäbisch-Gmünd, Mutlangen, , Germany
Hospital Schwabing, München, , Germany
Hospital rechts der Isar München, München, , Germany
Hospital Oldenburg, Oldenburg, , Germany
Hospital Passau, Passau, , Germany
Hospital Stuttgart, Stuttgart, , Germany
Diakonie Hospital Stuttgart, Stuttgart, , Germany
Hospital Traunstein, Traunstein, , Germany
Mutterhaus der Borromäerinnen, Trier, , Germany
Hospital Barmherzige Brüder Trier, Trier, , Germany
University Hospital Tübingen, Tübingen, , Germany
University Hospital Ulm, Ulm, , Germany
Contact Details
Name: Hartmut Döhner, Prof. Dr.
Affiliation: AMLSG Clinical Trials Office
Role: PRINCIPAL_INVESTIGATOR
Name: Peter Paschka, MD
Affiliation: University Hospital Ulm
Role: STUDY_CHAIR
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