Tretinoin and Arsenic Trioxide With or Without Gemtuzumab Ozogamicin in Treating Patients With Previously Untreated Acute Promyelocytic Leukemia

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 ozoga

Trial Details

NCT ID
NCT01409161
Phase
PHASE2
Sponsor
M.D. Anderson Cancer Center
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • Arsenic Trioxide
  • Gemtuzumab Ozogamicin
  • Laboratory Biomarker Analysis
  • Tretinoin
Locations (sample)
  • Houston, Texas, United States|29.76328,-95.36327
  • Houston, Texas, United States|29.76328,-95.36327
  • Nassau Bay, Texas, United States|29.54468,-95.09104
  • Sugar Land, Texas, United States|29.61968,-95.63495
  • The Woodlands, Texas, United States|30.15799,-95.48938

Key Eligibility Criteria

  • A diagnosis of APL based on the presence of the PML-RAR-alpha fusion gene by cytogenetics, polymerase chain reaction (PCR), or POD test
  • Ability to understand and the willingness to sign a written informed consent document indicating that they are aware of the investigational nature …
  • Patients in whom therapy for APL was initiated on an emergent basis are eligible (patients may have already started treatment with ATRA, ATO, and/o…
  • Women of child-bearing potential must have a negative serum pregnancy test at screening; in addition to having a negative pregnancy test confirmed …

For full eligibility, visit ClinicalTrials.gov.

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