At a glance
ClinicalIndex Comparison Record- ✓Previously untreated AML or high-risk MDS (>10% blasts or IPSS intermediate-2)
- ✓Age >60 years
- ✓ECOG performance status ≤2
- ✓Adequate liver function: total bilirubin <2 mg/dL, SGPT or SGOT <4× ULN
- ✕NYHA grade ≥3 heart disease
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized Phase II Study of Clofarabine Alone Versus Clofarabine in Combination With Low-Dose Cytarabine in Previously Untreated Patients >= 60 Years With AML and High-Risk MDS
In Brief
A Phase 2 clinical trial evaluating Clofarabine and Ara-C for Acute Myeloid Leukemia and Myelodysplastic Syndrome. Completed, enrolled 95 participants across 1 site.
Detailed Summary
The goal of this clinical research study is to study how effective treatments with clofarabine alone and clofarabine given in combination with ara-C are in the treatment of leukemia and high-risk myelodysplastic syndrome (MDS) in patients who are 60 years or older. The safety of these treatments will also be compared.
Study Details
Timeline
Interventions
1-hour IV infusion 30 mg/m\^2 daily times 5 days (Days 1-5)
20 mg/m\^2 subcutaneously daily times 14 days (Days 1-14). On Days 1 to 5 of each course, clofarabine will precede injection of ara-C by approximately 4 hours (+/- 1 hour).