Four-Arm Randomized Phase II Study of SGI-110: 5 days, versus 10 days, versus 5 days + idarubicin, versus 5 days + cladribine, in Previously Untreated Patients >/= 70 Years with Acute Myeloid Leukemia
The goal of this clinical research study is to compare different treatment schedules using the drug SGI-110 alone or in combination with other drugs. Researchers want to learn more about how these different treatment schedules may help to control AML. The safety of these treatments will also be studied.
Disease Group: Leukemia
Treatment Agent: Idarubicin,SGI-110
Treatment Location: Only at MDACC
To determine the complete remission (CR) rate, remission duration, leukemia-free survival, and survival in patients >/= 70 years with previously untreated AML with 4 different SGI-110 single agent and SGI-110 based combination regimens. To determine the safety profile and tolerability of the 4 SGI-110 single agent and SGI-110 based combination regimens in patients >/= 70 years of age with previously untreated AML.
IRB Review and Approval Date: 04/04/2014
Recruitment Status: Open
Projected Accrual: N/A
1) Previously untreated AML patients, except those who have received
prior therapy with hydroxyurea, single agent chemotherapy (e.g.
decitabine), hematopoietic growth factors, biological or targeted
therapies are allowed.
2) Age >/= 70 years
3) ECOG performance status </= 2.
4) Sign a written informed consent form.
5) Adequate liver function (total bilirubin </= 2mg/dL, SGPT or SGOT </= x 4 ULN) and renal function creatinine clearance of >/= 50 mL/min (estimated by the Cockroft-Gault [C-G] formula).
6) Male patients must use an effective contraceptive method during the study and for a minimum of 8 weeks after study treatment.
7) Baseline LVEF >/= 40%.
1) Patients with >/= NYHA grade 3 heart disease as assessed by
history and/or physical examination.
2) Patients who received more than one full course of prior hypomethylating agents azacitidine or decitabine
3) Have any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver, or other organ system that may place the patient at undue risk to undergo treatment.
4) Patients with a systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).
5) Pregnant or lactating patients.
6) Any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results
7) Any concurrent malignancy (with the exception of exclusion # 8)
8) Exceptions to # 7: a) Patients with treated non-melanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia, regardless of the disease-free duration, are eligible for this study if definitive treatment for the condition has been completed; b) Patients with organ-confined prostate cancer with no evidence of recurrent or progressive disease based on prostate-specific antigen (PSA) values are also eligible for this study if hormonal therapy has been initiated or a radical prostatectomy has been performed
Information and next steps
For general questions about clinical trials: