Phase II Study of Cladribine Plus Low Dose Cytarabine (LDAC) Induction Followed By Consolidation With Cladribine Plus LDAC Alternating With Decitabine in Patients With Untreated Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndrome (MDS)
M.D. Anderson Cancer Center
Summary
The goal of this clinical research study is to learn if cladribine given in combination with low-dose cytarabine (LDAC) and decitabine can help control the disease in patients with AML or MDS. The safety of this drug combination will also be studied. Cladribine is designed to interfere with the cell's ability to process DNA (the genetic material of cells). It can also insert itself into the DNA of cancer cells to stop them from growing and repairing themselves. Cytarabine is designed to insert itself into DNA of cancer cells to stop them from growing and repairing themselves. Decitabine is designed to damage the DNA of cells, which may cause cancer cells to die. This is an investigational study. Cladribine is FDA approved and commercially available for use in patients with hairy cell leukemia. Its use in patients with AML is investigational. Cytarabine is FDA approved and commercially available for use in patients with AML. Decitabine is FDA approved and commercially available for use in patients with MDS. Its use for patients with AML is investigational. Up to 160 patients will take part in this study. All will be enrolled at MD Anderson.
Description
Study Drug Administration: If you are eligible to take part in this study, you will receive 1 or 2 cycles of induction therapy followed by up to 17 cycles of consolidation therapy. Each study cycle is 4 weeks. Induction Cycles: On Days 1-5, you will receive cladribine by vein over 1-2 hours. On Days 1-10, you will give yourself the cytarabine by injection twice a day about 12 hours apart. You will receive instructions on how give yourself the injections. You may receive up to 2 cycles at this dose and schedule. Consolidation Cycles: Consolidation cycles will begin on Cycle 2 regardless…
Eligibility
- Age range
- 60+ years
- Sex
- All
- Healthy volunteers
- No
Cohort 1 Inclusion Criteria: 1. Patients with previously untreated AML or high risk MDS (\>/= 10 % blasts or IPSS \>/= intermediate-2). Prior therapy with hydroxyurea, hematopoietic growth factors, azacytidine, ATRA, or total dose of cytarabine up to 2g is allowed. Patients with history of MDS transformed to AML are eligible regardless of their prior therapy for MDS provided this will be their first induction therapy for AML. 2. Age \>/= 60 years. Patients aged \< 60 years who are unsuitable for standard induction therapy may be eligible after discussion with PI 3. Adequate organ function as…
Interventions
- DrugCladribine
Induction cycle: 5 mg/m2 by vein on days 1 - 5 for up to 2, 28 day cycles. Consolidation cycle: 5 mg/m2 by vein on days 1 - 3 of cycles 2, 5, 6, 9, 10, 13, 14, 17, and 18.
- DrugCytarabine
Induction cycle: 20 mg subcutaneously twice daily on days 1-10 for up to 2, 28 day cycles. Consolidation cycle: 20 mg subcutaneously twice daily on days 1 - 10 of cycles 2, 5, 6, 9, 10, 13, 14, 17, and 18.
- DrugDecitabine
Consolidation cycle: 20 mg/m2 by vein over 1 to 2 hours on days 1-5 of cycles 3, 4, 7, 8, 11, 12, 15, and 16.
Location
- University of Texas MD Anderson Cancer CenterHouston, Texas