Guadecitabine With or Without Idarubicin or Cladribine in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia

• Status: Completed
• Trial end date: 2020-11-24
• Target enrollment: 0
• Participant gender: All

Summary

This randomized phase II trial studies how well guadecitabine with or without idarubicin or cladribine works in treating older patients with previously untreated acute myeloid leukemia. Guadecitabine may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as idarubicin and cladribine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether guadecitabine with or without idarubicin or cladribine is more effective in treating older patients with previously untreated acute myeloid leukemia.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborators: Astex Pharmaceuticals; National Cancer Institute (NCI)
• Treatments: 2-chloro-3'-deoxyadenosine; Azacitidine; Cladribine; Guadecitabine; Idarubicin

Criteria

Inclusion Criteria:

• 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

• Eastern Cooperative Oncology Group (ECOG) performance status =< 2

• Sign a written informed consent form

• Total bilirubin =< 2 mg/dL

• Serum glutamate pyruvate transaminase (SGPT) or serum glutamic oxaloacetic transaminase (SGOT) =< 4 x upper limit of normal (ULN)

• Creatinine clearance of >= 50 mL/min (estimated by the Cockcroft-Gault [C-G] formula)

• Male patients must use an effective contraceptive method during the study and for a minimum of 8 weeks after study treatment

• Baseline left ventricular ejection fraction (LVEF) >= 40%

Exclusion Criteria:

• Patients with >= New York Heart Association (NYHA) grade 3 heart disease as assessed by history and/or physical examination

• Patients who received more than one full course of prior hypomethylating agents azacitidine or decitabine

• 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

• 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)

• Pregnant or lactating patients

• 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

• Any concurrent malignancy with the exception of the following: 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