Phase 2
Completed N=95
Clofarabine vs Clofarabine in Plus With Low-Dose Ara-C in Previously Untreated Patients With Acute Myeloid Leukemia (AML) and High-Risk Myelodysplastic Syndromes (MDS).
Source: ClinicalTrials.gov NCT00088218 ↗Enrolled (actual)
95
Serious AEs
53.7%
Results posted
May 2011
Primary outcomePrimary: Number of Participants With Response — 5; 49; 0; 4 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Response |
5; 49; 0; 4; 11; 26 | — |
Eligibility Criteria
Inclusion Criteria
- Previously untreated AML and high-risk MDS ( > 10% blasts, or International Prognostic Scoring System (IPSS) intermediate-2). Prior therapy with hydroxyurea, single agent chemotherapy (e.g. decitabine), hematopoietic growth factors, biological or "targeted" therapies are allowed.
- Age > 60 years.
- Eastern Cooperative Oncology Group (ECOG) performance status = New York Heart Association (NYHA) grade 3 heart disease as assessed by history and/or physical examination.
Data sourced from ClinicalTrials.gov (NCT00088218). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.