Clinical Trial SWOG 1203
- 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
- Jessica Altman
- Status: CLOSED
- Study Type: Therapeutic, Treatment
- Protocol No:.SWOG 1203
- The purpose of this study is to compare the effects, good and/or bad of three drug combinations on patients and their cancer. The combinations are: 1) daunorubicin plus AraC (called “7+3” treatment), 2) idarubicin plus AraC (called “IA” treatment), and 3) vorinostat added to IA therapy.
- This study is for patients who have acute myeloid leukemia (AML). In this study three different drug combinations will be compared. The first two combinations are standard treatment for AML. These are daunorubicin plus AraC (“7+3”) and idarubicin plus AraC (“IA”). Both of these treatments have been approved for AML. 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 AML, so it is considered investigational for this study. For patients who may benefit from a stem cell transplant, the study doctor also want to see if we can find stem cell transplant donors for patients.
Some of the eligibility criteria include:
- Participants must be newly diagnosed AML.
- Participants may have not received prior chemotherapy for their AML.
- Participants must be 18-60 years of age.
- Description of Treatment
- Study participants will be assigned to one of three treatment groups. In all three groups participants will have three phases of treatment: induction, consolidation and transplant. Participants in Group 1 will get 7+3 induction, then consolidation with AraC alone. Participants in Group two will get IA for both induction and consolidation. Participants in Group 3 will get IA + vorinostat for induction and consolidation. No matter what group participants are in for induction and consolidation, they will get a stem cell transplant if they have high-risk disease and have a donor available.
- Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
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- A Phase I, Open, Cohort Dose Escalation Trial with BI 836858 in Patients with Refractory or Relapsed Acute Myeloid Leukemia
- A Phase 1, Multicenter, Open-Label, Dose-Escalation, Safety, Pharmacokinetic, Pharmacodynamic, and Clinical Activity Study of Orally Administered AG-120 in Subjects with Advanced Hematologic Malignancies with an IDH1 Mutation
- A Phase 1, Multicenter, Open-Label, Dose-Escalation, Safety, Pharmacokinetic, Pharmacodynamic, and Clinical Activity Study of Orally Administered AG-221 in Subjects with Advanced Hematologic Malignancies with an IDH2 Mutation
- A Phase 1, Multicenter, Open-Label, Dose-Escalation and Expansion, Safety, Pharmacokinetic, Pharmacodynamic, and Clinical Activity Study of Orally Administered AG-881 in Patients with Advanced Hematologic Malignancies with an IDH1 and/or IDH2 Mutation
- A Phase I Study of Metformin and Cytarabine for the Treatment of Relapsed/Refractory Acute Myeloid Leukemia
- A Phase II Study of the BRAF Inhibitor, Vemurafenib, in Patients with Relapsed or Refractory Hairy Cell Leukemia
last updated: 01-Dec-15 07:31 PM
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