Phase 2
Completed N=30
Arsenic Trioxide and Gemtuzumab Ozogamicin in Treating Patients With Advanced Myelodysplastic Syndromes
Source: ClinicalTrials.gov NCT00274781 ↗Enrolled (actual)
30
Serious AEs
63.3%
Results posted
Jul 2015
Primary outcomePrimary: Complete and Partial Remission Per the International Working Group (IWG) Criteria for Myelodysplastic Syndromes (MDS) or Acute Myeloid Leukemia (AML) — 30; 25; 10 percentage of patients
Summary
RATIONALE: Drugs used in chemotherapy, such as arsenic trioxide and gemtuzumab ozogamicin, 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 arsenic trioxide together with gemtuzumab ozogamicin works in treating patients with advanced myelodysplastic syndromes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Complete and Partial Remission Per the International Working Group (IWG) Criteria for Myelodysplastic Syndromes (MDS) or Acute Myeloid Leukemia (AML) |
30; 25; 10 | — |
| SECONDARY Overall Survival |
9.7; 28.6; 7.6 | — |
| SECONDARY Tolerability |
17; 7; 5; 5; 3; 8 | — |
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of one of the following hematologic malignancies:
- Myelodysplastic syndromes (MDS) of one of the following French-American-British (FAB) classifications:
- Refractory anemia with excess blasts (RAEB) (WHO RAEB-1)
- RAEB in transformation (RAEB-t) (RAEB-2)
- Chronic myelomonocytic leukemia (CMML) with > 5% myeloblasts (WHO CMML-2)
- International Prognostic Scoring System (IPSS) score of intermediate-2 or higher in the setting of > 5% myeloblasts
- Acute myeloid leukemia that has evolved from MDS
- Must not be a candidate for bone marrow transplantation as first-line therapy or must have declined bone marrow transplantation
PATIENT CHARACTERISTICS:
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Life expectancy of at least 4 months
- Serum potassium ≥ 4.0 milliequivalent (mEq/dL) and serum magnesium ≥ 1.8 mg/dL (supplemental electrolytes allowed)
- Absolute corrected QT interval (QTc) interval 2.5 mg/dL
- serum glutamate oxaloacetate transaminase (SGOT) or serum glutamate pyruvate transaminase (SGPT) > 1.5 times upper limit of normal
- Bilirubin > 2.0 mg/dL
- No history of malignancy within the past 3 years other than MDS except basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast
- Arsenic trioxide is contraindicated in patients who are hypersensitive to arsenic
PRIOR CONCURRENT THERAPY:
- No prior bone marrow transplantation
- Must not receive another investigational or approved therapy for MDS within 4 weeks of study enrollment, including growth factors (within 1 week of study enrollment)
- No prior arsenic trioxide or gemtuzumab ozogamicin
- No other concurrent cytotoxic drugs or investigational agents
Data sourced from ClinicalTrials.gov (NCT00274781). 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.