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Type(s) of Cancer
Leukemia/Lymphoma
Study Phase
Phase 3
Study Completion Date
2016-07
NCT00651261Uploaded 04-28-2020
Access via NCI by Request
PDS UID: nci-data-409
A Phase III Randomized, Double-Blind Study of Induction (Daunorubicin/Cytarabine) and Consolidation (High-Dose Cytarabine) Chemotherapy + Midostaurin (PKC412) (IND #101261) or Placebo in Newly Diagnosed Patients < 60 Years of Age With FLT3 Mutated Acute Myeloid Leukemia (AML)
Provider Information
Provider Data DescriptionDataset NCT00651261-D1-Dataset.csv (baseline) is one of 5 datasets associated with PubMed ID 28644114. This dataset contains information that will allow you to reproduce the baseline characteristics table.
SponsorAlliance for Clinical Trials in Oncology
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThe purpose of this study is to compare the effects, good and/or bad, of a standard chemotherapy regimen for AML that includes the drugs daunorubicin and cytarabine combined with or without midostaurin (also known as PKC412), to find out which is better. This research is being done because it is unknown whether the addition of midostaurin to chemotherapy treatment is better than chemotherapy treatment alone. Midostaurin has been tested in over 400 patients and is being studied in a number of illnesses, including AML, colon cancer, and lung cancer. Midostaurin blocks an enzyme, produced by a gene known as FLT3, that may have a role in the survival and growth of AML cells. Not all leukemia cells will have the abnormal FLT3 gene. This study will focus only on patients with leukemia cells with the abnormal FLT3 gene.
ConditionsLeukemia
Intervention TypeDrug: cytarabine
Drug: daunorubicin
Drug: midostaurin
Other: placebo
Drug: dexamethasone acetate
Drug(s)Drug: cytarabine
Drug: daunorubicin
Drug: midostaurin
Drug: dexamethasone acetate
Total Enrolled717
RandomizationRandomized
Blinding MethodDouble
Arms InterventionInduction and consolidation chemotherapy plus midostaurin - Experimental
Induction and consolidation chemotherapy plus placebo - Active Comparator
Secondary IDCALGB-10603
PubMed (PMID)33049054
31375516
31171508
30382485
28644114
22627678
Collaborator(s)National Cancer Institute (NCI)
Novartis Pharmaceuticals
Region(s)United States
Canada
Age Range18 Years to 59 Years (ADULT)
Files: NCT00651261-D1
Data DictionaryNCT00651261-D1-Data-Dictionary_1.pdf
DATANCT00651261-D1-Dataset_1.csv
OTHERREADME.pdf
Files: NCT00651261-D2
Data DictionaryNCT00651261-D2-Data-Dictionary_1.pdf
DATANCT00651261-D2-Dataset_2.csv
OTHERREADME.pdf
Files: NCT00651261-D3
Data DictionaryNCT00651261-D3-Data-Dictionary_2.pdf
DATANCT00651261-D3-Dataset_1.csv
OTHERREADME.pdf
Files: NCT00651261-D4
Data DictionaryNCT00651261-D4-Data-Dictionary_3.pdf
DATANCT00651261-D4-Dataset_1.csv
OTHERREADME.pdf
Files: NCT00651261-D5
Data DictionaryNCT00651261-D5-Data-Dictionary_2.pdf
DATANCT00651261-D5-Dataset_1.csv
OTHERREADME.pdf
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