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This dataset is available to Authorized Users of the Project Data Sphere Cancer Research Platform through an initiative with the National Cancer Institute (NCI) of the U.S. National Institutes of Health (NIH). To gain access to this dataset, you must complete the following steps:

  1. Add the dataset to your request by clicking 'Add to Request' button below. You may add dataset(s) with up to 5 clinical trials in a single request.
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  3. Once your request is approved, you will receive notice that you have access to the dataset(s) in SAS® Life Sciences Analytic Framework within the Project Data Sphere Cancer Research Platform and that you may download the dataset(s) onto a personal machine.

To be able to request access to this data and the other analytic tools click here.

Leukemia

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)

Unique Dataset IDnci-data-409ClinicalTrial.gov IDNCT00651261
DownloadableNo
SponsorAlliance for Clinical Trials in OncologyData ProviderNational Cancer InstituteTotal Study Enrolled Patients717RandomizationYesPubMed (PMID)28644114.0
Study PhaseClinical Study Phase IIIBlinding MethodDouble-BlindedType(s) of dataN/AIntervention TypePlacebo, DrugDataset TypeOther

Clinical Trial Title

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)

Trial Summary and Conditions

The 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.

Data Summary

See Data Dictionary.

Study Objectives

PRIMARY OBJECTIVES: 1. To determine if the addition of midostaurin to daunorubicin/cytarabine induction, high-dose cytarabine consolidation, and continuation therapy improves overall survival (OS) in both the mutant FLT3-ITD and FLT3-TKD AML patients. SECONDARY OBJECTIVES: 1. To compare the overall survival (OS) in the two groups using an analysis in which patients who receive a stem cell transplant are censored at the time of transplant; 2.To compare the complete response (CR) rate between the two treatment groups; 3. To compare the event-free survival (EFS) between the two treatment groups; 4. To compare the disease free survival (DFS) of the two treatment groups; 5. To compare the disease free survival rate one year after completion of the continuation phase of the two groups; 6. To assess the toxicity of the experimental combination; 7. To describe the interaction between treatment outcome and pretreatment characteristics such as age, performance status, white blood cell (WBC) count, morphology, cytogenetics, and molecular and pharmacodynamic features; 8. To assess the population pharmacokinetics (popPK) of midostaurin and its two major metabolites (CGP52421 and CGP62221). The potential association(s) between PK exposure and FLT3 status, OS, EFS and clinical response will be explored.

Outcome Measures

PRIMARY OUTCOME MEASURES: 1. Overall Survival (OS). SECONDARY OUTCOME MEASURES: 1. Event- Free Survival; 2. Overall Survival, Censoring Participants Who Receive a Stem Cell Transplant at the Time of the Transplant; 3. Complete Response Rate; 4. Disease-free Survival (DFS); 5. DFS Rate One Year After Completing the Planned Continuation Phase.

ClinicalTrial.gov

Below are the clinical trial(s) associated with this dataset (all links are to ClinicalTrials.Gov):

NCI Description

Dataset 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.

Available Downloads: NCT00651261-D1

To gain access to the data and analytic tools click here.

Data Dictionary: NCT00651261-D1-Data-Dictionary_1.pdf

DATA: NCT00651261-D1-Dataset_1.csv

OTHER: README.pdf

Available Downloads: NCT00651261-D2

To gain access to the data and analytic tools click here.

Data Dictionary: NCT00651261-D2-Data-Dictionary_1.pdf

DATA: NCT00651261-D2-Dataset_2.csv

OTHER: README.pdf

Available Downloads: NCT00651261-D3

To gain access to the data and analytic tools click here.

Data Dictionary: NCT00651261-D3-Data-Dictionary_2.pdf

DATA: NCT00651261-D3-Dataset_1.csv

OTHER: README.pdf

Available Downloads: NCT00651261-D4

To gain access to the data and analytic tools click here.

Data Dictionary: NCT00651261-D4-Data-Dictionary_3.pdf

DATA: NCT00651261-D4-Dataset_1.csv

OTHER: README.pdf

Available Downloads: NCT00651261-D5

To gain access to the data and analytic tools click here.

Data Dictionary: NCT00651261-D5-Data-Dictionary_2.pdf

DATA: NCT00651261-D5-Dataset_1.csv

OTHER: README.pdf