Filgrastim, Cladribine, Cytarabine and Mitoxantrone With or Without Sorafenib Tosylate in Treating Patients With Newly-Diagnosed, High-Risk Acute Myeloid Leukemia or Myelodysplastic Syndrome | Aplastic Anemia and MDS International Foundation

Clinical Trial: NCT02728050

Filgrastim, Cladribine, Cytarabine and Mitoxantrone With or Without Sorafenib Tosylate in Treating Patients With Newly-Diagnosed, High-Risk Acute Myeloid Leukemia or Myelodysplastic Syndrome
For more details on this clinical trial, including contact information, please see this trial’s listing on clinicaltrials.gov:
Purpose: 

This phase I/II trial studies the side effects and best dose of filgrastim (granulocyte colony-stimulating factor [G-CSF]), cladribine, cytarabine, mitoxantrone hydrochloride, when given together with sorafenib tosylate and to see how well they work in treating patients with newly-diagnosed acute myeloid leukemia or myelodysplasticsyndrome that is likely to come back or spread (high-risk). Drugs used in chemotherapy, such as filgrastim, cladribine, cytarabine, and mitoxantrone hydrochloride work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Sorafenib tosylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving filgrastim, cladribine, cytarabine, and mitoxantrone hydrochloride together with sorafenib tosylate may kill more cancer cells.

Status: 
Recruiting
Study Date: 
Sun, 05/01/2016 to Sat, 12/01/2018
Bone Marrow Disease(s): 
myelodysplastic syndromes (MDS)
Associated Drug(s): 
Intervention: 
Drug: Cladribine Given IV Other Names: 2-CdA 2CDA CdA Cladribina Leustat Leustatin Leustatine RWJ-26251 Drug: Cytarabine Given IV Other Names: .beta.-Cytosine arabinoside 1-.beta.-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone 1-.beta.-D-Arabinofuranosylcytosine 1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinone 1-Beta-D-arabinofuranosylcytosine 1.beta.-D-Arabinofuranosylcytosine 2(1H)-Pyrimidinone, 4-Amino-1-beta-D-arabinofuranosyl- 2(1H)-Pyrimidinone, 4-amino-1.beta.-D-arabinofuranosyl- Alexan Ara-C ARA-cell Arabine Arabinofuranosylcytosine Arabinosylcytosine Aracytidine Aracytin Aracytine Beta-Cytosine Arabinoside CHX-3311 Cytarabinum Cytarbel Cytosar Cytosar-U Cytosine Arabinoside Cytosine-.beta.-arabinoside Cytosine-beta-arabinoside Erpalfa Starasid Tarabine PFS U 19920 U-19920 Udicil WR-28453 Biological: Filgrastim Given SC Other Names: Filgrastim XM02 G-CSF Neupogen r-metHuG-CSF Recombinant Methionyl Human Granulocyte Colony Stimulating Factor rG-CSF Tbo-filgrastim Tevagrastim Other: Laboratory Biomarker Analysis Correlative studies Drug: Mitoxantrone Hydrochloride Given IV Other Names: CL 232315 DHAD DHAQ Dihydroxyanthracenedione Dihydrochloride Mitoxantrone Dihydrochloride Mitoxantroni Hydrochloridum Mitozantrone Hydrochloride Mitroxone Neotalem Novantrone Onkotrone Pralifan Other: Quality-of-Life Assessment Ancillary studies Other Name: Quality of Life Assessment Drug: Sorafenib Tosylate Given PO Other Names: BAY 43-9006 Tosylate BAY 54-9085 Nexavar sorafenib