Response-Based Chemotherapy in Treating Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome in Younger Patients With Down Syndrome | Aplastic Anemia and MDS International Foundation

Clinical Trial: NCT02521493

Response-Based Chemotherapy in Treating Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome in Younger Patients With Down Syndrome
For more details on this clinical trial, including contact information, please see this trial’s listing on

This phase III trial studies response-based chemotherapy in treating newly diagnosed acute myeloid leukemia or myelodysplastic syndrome in younger patients with Down syndrome. Drugs used in chemotherapy 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. Response-based chemotherapy separates patients into different risk groups and treats them according to how they respond to the first course of treatment (Induction I). Response-based treatment may be effective in treating acute myeloid leukemia ormyelodysplastic syndrome in younger patients with Down syndrome while reducing the side effects.

Study Date: 
Sun, 11/01/2015 to Sun, 12/01/2019
Bone Marrow Disease(s): 
myelodysplastic syndromes (MDS)
Drug: Asparaginase Given IM or IV Other Names: ASP-1 Asparaginase II Asparaginase-E.Coli Colaspase Elspar Kidrolase L-Asnase L-ASP L-Asparaginase L-Asparagine Amidohydrolase Laspar Lcf-ASP Leucogen Leunase MK-965 Paronal Re-82-TAD-15 Serasa Drug: Asparaginase Erwinia chrysanthemi Given IM or IV Other Names: Crisantaspasum Cristantaspase Erwinase Erwinaze L-asparginase (Erwinia ) Drug: Cytarabine Given IT and 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 Drug: Daunorubicin Hydrochloride Given IV Other Names: Cerubidin Cerubidine Cloridrato de Daunorubicina Daunoblastin Daunoblastina Daunoblastine Daunomycin Hydrochloride Daunomycin, hydrochloride Daunorubicin.HCl Daunorubicini Hydrochloridum FI-6339 Ondena RP-13057 Rubidomycin Hydrochloride Rubilem Drug: Etoposide Given IV Other Names: Demethyl Epipodophyllotoxin Ethylidine Glucoside EPEG Lastet Toposar Vepesid VP 16-213 VP-16 VP-16-213 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 Drug: Thioguanine Given PO Other Names: 2-Amino 6MP 2-Amino-1,7-dihydro-6H-purine-6-thione 2-Amino-6-mercaptopurine 2-Amino-6-purinethiol 2-Aminopurin-6-thiol 2-Aminopurine-6(1H)-thione 2-Aminopurine-6-thiol 2-Mercapto-6-aminopurine 6-Amino-2-mercaptopurine 6-Mercapto-2-aminopurine 6-Mercaptoguanine 6-TG 6H-Purine-6-thione, 2-amino-1,7-dihydro- (9CI) BW 5071 Lanvis Tabloid Tioguanin Tioguanine Wellcome U3B WR-1141 X 27