Phase 2
Completed N=58
2 Arm Study of Clofarabine IV in MDS Patients
Source: ClinicalTrials.gov NCT00422032 ↗Enrolled (actual)
58
Serious AEs
25.9%
Results posted
Jul 2012
Primary outcomePrimary: Number of Participants With Response for Two Dose Schedules of Clofarabine — 10; 5; 5; 1 Participants
Summary
The goal of this clinical research study is to compare the effectiveness of 2 different doses of the drug clofarabine that can be given on a weekly schedule for the treatment of Myelodysplastic Syndrome (MDS). The safety of these two doses will also be compared.
Primary Objective: Compare the response rates of two dose schedules of clofarabine in MDS.
Secondary Objective: Compare response durations, survivals and side effects of the two schedules.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Response for Two Dose Schedules of Clofarabine |
10; 5; 5; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with MDS and >/= 5% blasts or International Prognostic Scoring System (IPSS) risk intermediate or high; patients with Chronic Myelomonocytic Leukemia (CMML).
- No prior intensive chemotherapy or high-dose ara-C (> 1g/m2).
- Prior biologic therapies, targeted therapies, or single agent chemotherapy allowed.
- Patients must have been off chemotherapy for 2 weeks prior to entering this study and recovered from the toxic effects of that therapy, unless there is evidence of rapidly progressive disease.
- Hydroxyurea is permitted for control of counts prior to treatment.
- Procrit, GCSF are allowed before therapy.
- Performance 0-2 (Eastern Cooperative Oncology Group (ECOG)). Adequate organ function including the following: Adequate liver function (bilirubin of < 2mg/dl), and renal function (creatinine < 2mg/dl), and SGPT (ALT) < 3 * upper limit of normal (ULN). Adequate cardiac functions (New York Heart Association (NYHA) cardiac III-IV excluded).
- Signed informed consent.
Exclusion Criteria
- Nursing and pregnant females. Patients of childbearing potential should practice effective methods of contraception. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- Active and uncontrolled infections.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements.
- Prior clofarabine treatment.
Data sourced from ClinicalTrials.gov (NCT00422032). 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.