Alert icon

To align with industry best practices for security and data integrity, Project Data Sphere is requiring users to upgrade their browsers to one that supports encryption protocol TLS 1.2 by December 15, 2017. On that date, Project Data Sphere will disable support of browsers that permit SSL 3.0/TLS 1.0. To prevent any disruption to your access to Project Data Sphere, you must take action.
This browser was not recognized and may not be compatible with TLS 1.2 or higher. Please check with the browser's developer to confirm.
To view information about this, please visit the FAQ. If you have any further questions, please contact us.

Back to the List
Type(s) of Cancer
Leukemia/Lymphoma
Study Phase
Phase 3
Study Completion Date
2007-06
NCT00085124Uploaded 05-25-2024
Access via NCI by Request
PDS UID: nci-data-544
A Phase III Study of Daunorubicin and Cytarabine +/- G3139 (Genasense, Oblimersen Sodium, NSC #683428, IND #58842), a BCL2 Antisense Oligodeoxynucleotide, in Previously Untreated Patients With Acute Myeloid Leukemia (AML) > / = 60 Years
Provider Information
Provider Data DescriptionThis dataset contains patient characteristics and outcome data presented in the publication. NCT00085124-D2 contains adverse event information.
SponsorNational Cancer Institute (NCI)
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis randomized phase III trial is studying daunorubicin, cytarabine, and oblimersen to see how well they work compared to daunorubicin and cytarabine in treating older patients with previously untreated acute myeloid leukemia. Drugs used in chemotherapy, such as daunorubicin and cytarabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Oblimersen may increase the effectiveness of daunorubicin and cytarabine by making cancer cells more sensitive to the drugs. It is not yet known whether daunorubicin and cytarabine are more effective with or without oblimersen in treating acute myeloid leukemia.
ConditionsAdult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)
Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
Secondary Acute Myeloid Leukemia
Untreated Adult Acute Myeloid Leukemia
Intervention TypeBiological: oblimersen sodium
Drug: cytarabine
Drug: daunorubicin hydrochloride
Other: laboratory biomarker analysis
Drug(s)Drug: cytarabine
Drug: daunorubicin hydrochloride
Total Enrolled500
RandomizationRandomized
Blinding MethodNone
Arms InterventionArm I - Experimental
Arm II - Experimental
Secondary IDCALGB-10201
PubMed (PMID)34251414
31375516
31171508
Collaborator(s)N/A
Region(s)United States
Age Range60 Years and older (ADULT, OLDER_ADULT)
Files: NCT00085124-D1
Data DictionaryNCT00085124-D1-Data-Dictionary_1.pdf
DATANCT00085124-D1-Dataset_1.csv
OTHERREADME.pdf
Files: NCT00085124-D2
Data DictionaryNCT00085124-D2-Data-Dictionary_1.pdf
DATANCT00085124-D2-Dataset_1.csv
OTHERREADME.pdf
© 2024 Project Data Sphere
All rights reserved
Privacy PolicyTerms of Use