Clinical trial · Interventional
Arsenic Trioxide in Combination With Cytarabine in Patients With High-risk MDS and Poor-prognosis AML
Phase I/II Study of Arsenic Trioxide in Combination With Cytosine Arabinoside in Patients With High-risk Myelodysplastic Syndrome and Poor-prognosis Acute Myelogenous Leukemia
NCT00195104CI-TRIAL-00026264completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to find out the effectiveness and side effects of arsenic trioxide in combination with low-dose ara-C.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Myelodysplastic Syndrome | Myelodysplastic Syndrome | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Arsenic Trioxide (Tricenox) | Drug | Arsenic Trioxide | ALIAS |
| Cytarabine | Drug | Cytarabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- All Patients
- description
- Arsenic trioxide \[TrisenoxTM Injection\], 0.25mg/kg/dose administered intravenously over 1 to 4 hours
- interventionNames
- Drug: Arsenic Trioxide (Tricenox)
- Drug: Cytarabine
Primary outcomes (2)
- measure
- To determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of cytosine arabinoside in combination with ATO 0.25mg/kg/day IV for 10 days on therapy followed by 14 days off therapy in patients with high-risk MDS and poor-prognosis AML.
- timeFrame
- 10 days on therapy followed by 14 days off therapy in patients with high-risk MDS and poor-prognosis AML
- measure
- To characterize the safety and tolerability of the combination of ATO and low-dose ara-C, including acute and chronic toxicities.
- timeFrame
- 4 weeks after the last study treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologic diagnosis of high-risk MDS (IPSS int-2). * No prior cytotoxic therapy for MDS or AML (patients may have received prior therapy with hematopoietic growth factors, immunomodulatory agents or 5-azacitidine). Exclusion Criteria: * Pregnant or lactating women. * Absolute QT interval \>460 msec in the presence of serum potassium and magnesium values within the normal range. * Concurrent treatment with maintenance therapy, cytotoxic chemotherapy, radiation, or investigational agents. * Uncontrolled or severe cardiovascular or pulmonary disease.
References
Publications (0)
Data not yet available
No reference posted for this study.