CLINICAL TRIAL SUMMARY

MDACC Study No:S1203 (clinicaltrials.gov NCT No: NCT01802333)
Title:A Randomized Phase III Study of Standard Cytarabine plus Daunorubicin (7+3) Therapy or Idarubicin with High Dose Cytarabine (IA) versus IA with Vorinostat (IA+V) in Younger Patients with Previously Untreated Acute Myeloid Leukemia (AML)
Principal Investigator:Guillermo Garcia-Manero
Treatment Agent:Cytarabine; Daunorubicin; Idarubicin; Vorinostat
Study Status:Open
Study Description:The purpose of this study is to compare the effects, good and/or bad of three
drug combinations. The first combination is the standard treatment of
daunorubicin plus AraC. This is called “7+3” treatment. The second
combination is another standard treatment of idarubicin plus AraC. This is
called “IA” treatment. Both of these treatments have been approved for your
cancer. The third combination will add the drug vorinostat to the standard IA
therapy. Vorinostat is approved for other types of cancer, but has not been
approved for your type of cancer, so it is considered investigational for this
study. We want to compare the effects of these three treatments on your type
of cancer.

We want to see if the study treatments will get rid of leukemia cells and keep
them from coming back for patients who may benefit from stem cell transplant.
We also want to see if we can find stem cell transplant donors for patients who
might benefit from a transplant according to standard practice, beginning at
the time you register for the study.

Hide details for General InformationGeneral Information

Disease Group:Leukemia
Phase of Study:Phase III
Treatment Agents:Cytarabine
Daunorubicin
Idarubicin
Vorinostat
Treatment Location:Both at MDACC & and Other Sites
Estimated Length of Stay in Houston:
Supported By:NCI Cancer Trials Support Unit (CTSU)
SWOG
Return Visit:
Home Care:


Hide details for Study Contact InformationStudy Contact Information

Physician Name:Guillermo Garcia-Manero
Dept:Leukemia
For Clinical Trial Enrollment:713-745-3428
For General Questions about Clinical Trials:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)


Show details for Study Objectives / OutcomesStudy Objectives / Outcomes
Show details for Study Status InformationStudy Status Information
Show details for Enrollment EligibilityEnrollment Eligibility
Show details for Resources and LinksResources and Links
Show details for ResultsResults