Phase 2
Completed N=282
Clofarabine, Idarubicin, and Cytarabine (CIA) Versus Fludarabine, Idarubicin, and Cytarabine (FLAI) in Acute Myelogenous Leukemia (AML) and High-Risk Myelodysplastic Syndrome
Source: ClinicalTrials.gov NCT01289457 ↗Enrolled (actual)
282
Serious AEs
79.8%
Results posted
Feb 2020
Primary outcomePrimary: Maximum Tolerated Dose (MTD) of Clofarabine, Idarubicin, and Cytarabine — 15 mg/m^2
Summary
The goal of this clinical research study is to learn if the combination of clofarabine, idarubicin, and cytarabine, or the combination of fludarabine, idarubicin, and cytarabine can help control Acute myeloid leukemia (AML) and Myelodysplastic syndromes (MDS). The safety of these study drug combinations will also be studied.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Tolerated Dose (MTD) of Clofarabine, Idarubicin, and Cytarabine |
15 | — |
| SECONDARY Response Rates of Clofarabine, Idarubicin, and Cytarabine (CIA) Versus Fludarabine, Idarubicin, and Cytarabine (FLAI) |
107; 76 | — |
| SECONDARY Event-Free Survival (EFS) at 2 Years |
7.1; 8.4 | — |
| SECONDARY Overall Survival |
14.5; 15.1 | — |
Eligibility Criteria
Inclusion Criteria
- Sign an Institutional Review Board (IRB)-approved informed consent document.
- Age 18 to 60. Patients above the age of 60 only with principal investigator (PI) approval
- Diagnosis of newly diagnosed AML [other than acute promyelocytic leukemia (APL)] or high-risk (intermediate-2 or high by International Prostate Symptom Score (IPSS) or > 10% blasts, including CMML) MDS. Prior therapy with hydrea and the use of a single or a two day dose of cytarabine (up to 3 g/m2) for emergency use up to 24 hours prior to start of study therapy is allowed. Prior therapy for MDS or other AHD is not allowed.
- Eastern Cooperative Oncology Group (ECOG) performance status of /= 40% (by either cardiac echo or multiple gated acquisition scan (MUGA) scan). Documentation of recent (</= 6 months from screening) outside reports is acceptable.
Exclusion Criteria
- Breast feeding females
- Patients with uncontrolled active infections (viral, bacterial, and fungal are not eligible).
- Patients with active secondary malignancy will not be eligible.
Data sourced from ClinicalTrials.gov (NCT01289457). 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.