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Acute Promyelocytic Leukemia With PML-RARAChildren's healthDrugPhase 2

What this study is

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.

What's being tested

  • Arsenic Trioxide

    Intervention · DRUG

  • Gemtuzumab Ozogamicin

    Intervention · DRUG

  • Laboratory Biomarker Analysis

    Intervention · OTHER

    Correlative studies

  • Tretinoin

    Intervention · DRUG

    Given PO

Both Arsenic Trioxide and Gemtuzumab Ozogamicin

Given IV

Study details

Official title
Phase II Study of Treatment of Acute Promyelocytic Leukemia (APL) With ATRA, Arsenic Trioxide and Gemtuzumab Ozogamicin (GO)
Sponsor
M.D. Anderson Cancer Center
Conditions
Acute Promyelocytic Leukemia With PML-RARA
Enrolling
151 people
Starts
2011-10-05
Est. completion
2027-12-18
Design
Open-label, single group, Phase 2
Record
View on ClinicalTrials.gov ↗