Clinical trial · Interventional
Azacitidine and Arsenic Trioxide in Treating Patients With Myelodysplastic Syndromes or Chronic Myelomonocytic Leukemia
A Phase II Study of Arsenic Trioxide in Combination With 5-Azacitidine in Myelodysplastic Syndromes
NCT00118196CI-TRIAL-00032874terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Due to limited resources available to conduct study
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy, such as azacitidine and arsenic trioxide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving azacitidine together with arsenic trioxide works in treating patients with myelodysplastic syndromes or chronic myelomonocytic leukemia.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| arsenic trioxide | Drug | Arsenic Trioxide | ALIAS |
| azacitidine | Drug | Azacitidine | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Response rate (overall and confirmed) as measured by International Working Group (IWG) standardized criteria for MDS at day 113 and then every 4 weeks until completion of study treatment
Secondary outcomes (3)
- measure
- Time to treatment failure as assessed by the Kaplan-Meier method at completion of study treatment
- measure
- Progression-free survival as assessed by the Kaplan-Meier method at completion of study treatment
- measure
- Toxicity as assessed by the Kaplan-Meier method and NCI-CTCAE version 3.0 during treatment until 30 days after completion of study treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Diagnosis of myelodysplastic syndrome or chronic myelomonocytic leukemia
* International Prognostic Scoring System (IPSS) score ≥ intermediate-1
* Low IPSS score allowed provided patient meets ≥ 1 of the following criteria:
* Platelet count ≤ 50,000/mm\^3
* Required platelet or packed red cell transfusions within the past 4 weeks
* Neutropenic (i.e., absolute neutrophil count \< 1,000/mm\^3) AND has infections requiring antibiotic treatment
* No prior leukemia or refractory anemia with excess blasts in transformation
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-2
Life expectancy
* More than 12 weeks
Hematopoietic
* See Disease Characteristics
Hepatic
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* AST and ALT ≤ 2.5 times ULN
Renal
* Creatinine ≤ 1.5 times ULN
Cardiovascular
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia
* Baseline QTc \< 500 msec
* QTc interval \< 460 msec with potassium \> 4.0 mEq/L and magnesium \> 1.8 mg/L
Immunologic
* No history of allergic reaction attributed to compounds of similar chemical or biologic composition to study drugs
* No ongoing or active infection
* HIV negative
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 6 months after study participation
* No psychiatric illness or social situation that would preclude study compliance
* No other uncontrolled illness
* No other malignancy within the past 12 months
PRIOR CONCURRENT THERAPY:
Biologic therapy
* More than 4 weeks since prior administration of any of the following:
* Interferon
* Filgrastim (G-CSF), sargramostim (GM-CSF), epoetin alfa, or other hematopoietic cytokines
* Thalidomide or thalidomide analogs
* No concurrent epoetin alfa
Chemotherapy
* More than 4 weeks since prior chemotherapy
* No prior arsenic trioxide or azacitidine
* No other concurrent chemotherapy
Endocrine therapy
* More than 4 weeks since prior steroids
* No concurrent androgenic steroids
* Concurrent steroids for adrenal failure or as prophylaxis for nausea allowed
Radiotherapy
* Not specified
Surgery
* Not specified
Other
* More than 4 weeks since prior retinoids
* No other concurrent investigational agents
* No other concurrent anticancer therapyReferences
Publications (0)
Data not yet available
No reference posted for this study.