Phase 2
Completed N=6
Cephalon Decitabine, Arsenic Trioxide and Ascorbic Acid for Myelodysplastic Syndrome
Source: ClinicalTrials.gov NCT00621023 ↗Enrolled (actual)
6
Serious AEs
66.7%
Results posted
Jan 2013
Primary outcomePrimary: Number of Patients With an Overall Response of Complete Response (CR) or Partial Response (PR) — 0 participants
Summary
This will be an open-label, non-randomized trial pilot phase II trial open to patients with myelodysplastic syndrome. The purpose of the study is to find out if the combination of decitabine, arsenic trioxide and ascorbic acid is safe.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With an Overall Response of Complete Response (CR) or Partial Response (PR) |
— | — |
| SECONDARY Duration of a Complete or Partial Response Based on Number of People Who Responded. |
— | — |
| SECONDARY Number of Patients With an Unacceptable Toxicity |
4 | — |
Eligibility Criteria
Inclusion Criteria
- Established diagnosis of MDS (de novo or secondary) fitting either the French American British Cooperative Group (FAB) or World Health Organization (WHO) classification systems as determined by a complete blood count (CBC) and bone marrow biopsy. Patients with >20% bone marrow blasts but 30% bone marrow blasts.
- Any malignant disease within the past 2 years, except cervical carcinoma, basal cell carcinoma of the skin, and squamous cell carcinoma of the skin..
- Off all prior treatment for MDS for at least 4 weeks from entry.
- Off any investigational agents for at least 4 weeks from entry.
- Uncontrolled cardiac disease or congestive heart failure as defined by New York Heart Association criteria of Class III or greater.
- Uncontrolled pulmonary disease.
- Uncontrolled or active viral or bacterial infection. All infections must have been fully treated with antibiotics.
- HIV +
- Lab values as specified in the protocol
Data sourced from ClinicalTrials.gov (NCT00621023). 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.