Clinical Trial DRUG CYC682-06
- A Randomized Phase II Study of Oral Sapacitabine in Elderly Patients with Acute Myeloid Leukemia Previously Untreated or in First Relapse
- Principal Investigator
- Jessica Altman
- Status: CLOSED
- Study Type: Therapeutic, Treatment
- Protocol No:.DRUG CYC682-06
- The purpose of this study is to learn that among the 3 different sapacitabine treatments, which one is more likely to keep the cancer in check for at least one year in in adults 70 years old and older who have either not been treated or have disease that has returned after one treatment. Three doses of the study drug sapacitabine will be evaluated for its effectiveness as a treatment for AML. The study will also evaluate the side effects of the three different sapacitabine treatments.
- Sapacitabine works by pausing or stopping the cancer cell from growing at a unique point in the growth process. It causes the production of the DNA in cells to become interrupted or to be terminated.
Some of the eligibility criteria include:
- Participants must be 70 yrs old or older.
- Participants must have AML that has either not been treated or is in the first relapse (the AML has returned) after having achieved a complete remission.
- Participants cannot have had more than one prior induction therapy. All prior therapy should be discussed with the study doctor.
- Participants cannot be HIV positive.
- Description of Treatment
- Participants will be randomly assigned by a computer to take one of the three treatments. The length of time in this study may vary. The length of time will be measured in cycles with each cycle being equivalent to 3 weeks or 21 days. The first treatment is a 7-day low dose treatment. Participants will take a lower dose of the study drug for 7 days in a row followed by 2 weeks of no study drug. The second treatment is a 7-day high dose treatment. Participants will take this medium dose of study drug for 7 days in a row followed by 2 weeks of no study drug. The final treatment is 3 days of the high dose treatment. Participants will receive this highest dose of study drug for 3 days in a row per week for 2 weeks followed by 1 week of no study drug.
- 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 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
- 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)
last updated: 07-Oct-15 10:42 AM
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