OncoMatch/Clinical Trials/NCT01409161
Tretinoin and Arsenic Trioxide With or Without Gemtuzumab Ozogamicin in Treating Patients With Previously Untreated Acute Promyelocytic Leukemia
Is NCT01409161 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Arsenic Trioxide and Gemtuzumab Ozogamicin for acute promyelocytic leukemia with pml-rara.
Treatment: Arsenic Trioxide · Gemtuzumab Ozogamicin · Tretinoin — This phase II trial studies how well tretinoin and arsenic trioxide with or without gemtuzumab ozogamicin works in treating patients with previously untreated acute promyelocytic leukemia. Drugs used in chemotherapy, such as tretinoin and arsenic trioxide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotoxins, such as gemtuzumab ozogamicin, may find certain cancer cells and kill them without harming normal cells. Giving tretinoin and arsenic trioxide together with gemtuzumab ozogamicin may kill more cancer cells.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Biomarker criteria
Required: PML PML-RARA fusion
A diagnosis of APL based on the presence of the PML-RAR-alpha fusion gene by cytogenetics, polymerase chain reaction (PCR), or POD test
Required: RARA PML-RARA fusion
A diagnosis of APL based on the presence of the PML-RAR-alpha fusion gene by cytogenetics, polymerase chain reaction (PCR), or POD test
Lab requirements
Kidney function
Patients with creatinine > 2.5 times upper limit of normal unless felt to be related the underlying leukemia by the treating physician or hemolysis or Gilbert's disease
Liver function
Patients with total bilirubin >= 2.0 times upper limit of normal unless felt to be related the underlying leukemia by the treating physician or hemolysis or Gilbert's disease; ALT/AST > 3 times upper limit of normal unless felt to be related the underlying leukemia by the treating physician or hemolysis or Gilbert's disease
Cardiac function
Fridericia corrected QT (QTcF) interval on the electrocardiogram (EKG) greater than 480 milliseconds
Fridericia corrected QT (QTcF) interval on the electrocardiogram (EKG) greater than 480 milliseconds; Patients with creatinine > 2.5 times upper limit of normal unless felt to be related the underlying leukemia by the treating physician or hemolysis or Gilbert's disease; Patients with total bilirubin >= 2.0 times upper limit of normal unless felt to be related the underlying leukemia by the treating physician or hemolysis or Gilbert's disease; Patients with alanine aminotransferase (ALT)/aspartate aminotransferase (AST) > 3 times upper limit of normal unless felt to be related the underlying leukemia by the treating physician or hemolysis or Gilbert's disease
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- M D Anderson Cancer Center · Houston, Texas
- MD Anderson Regional Care Center-Katy · Houston, Texas
- MD Anderson Regional Care Center-Bay Area · Nassau Bay, Texas
- MD Anderson Regional Care Center-Sugar Land · Sugar Land, Texas
- MD Anderson Regional Care Center-The Woodlands · The Woodlands, Texas
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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