At a glance
ClinicalIndex Comparison Record- ✓Previously untreated AML or high-risk MDS (≥10% blasts or IPSS ≥intermediate-2)
- ✓Age ≥60 years (Cohort 1)
- ✓Age ≥18 years unsuitable for standard induction therapy (Cohort 2)
- ✓At least one of: creatinine ≥2 mg/dL, bilirubin ≥2 mg/dL, ECOG 3-4, ineligible for higher priority protocol (Cohort 2)
- ✕Pregnancy
- ✕Breastfeeding
- ✕Uncontrolled intercurrent illness including infection, heart failure, angina, arrhythmia, or psychiatric illness
- ✕Documented hypersensitivity to chemotherapy components
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 2 clinical trial evaluating Cladribine, Cytarabine, and 1 other intervention for Leukemia. Currently recruiting, targeting 160 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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.
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.
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.