Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities Clinical Trial
Official title:
Phase II Trial of Vorinostat (Suberoylanilide Hydroxamic Acid or SAHA; Zolinza™) in Combination With Gemtuzumab Ozogamicin (Mylotarg™) as Induction and Post-Remission Therapy in Older Patients With Previously Untreated Non-M3 Acute Myeloid Leukemia
RATIONALE: Vorinostat may stop the growth of cancer cells by interfering with various
proteins needed for cell growth. Monoclonal antibodies, such as gemtuzumab ozogamicin (GO),
can block cancer growth in different ways. GO finds cancer cells and helps kill them by
carrying a cancer-killing substance to them. Giving vorinostat together with gemtuzumab
ozogamicin may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving vorinostat together with gemtuzumab
ozogamicin works in treating older patients with previously untreated acute myeloid
leukemia.
PRIMARY OBJECTIVES:
I. To determine the CR/CRi rate after treatment with vorinostat plus GO. (Good risk group)
II. To determine the 30-day survival after treatment with vorinostat plus GO. (Poor risk
group)
SECONDARY OBJECTIVES:
I. To estimate the frequency and severity of regimen-associated toxicities, along with
30-day survival after start of treatment with vorinostat plus GO. (Good risk group) II. To
determine the CR/CRi rate after treatment with vorinostat plus GO, and estimate the
frequency and severity of regimen-associated toxicities. (Poor risk group) III. To
investigate the relapse-free survival of patients who achieve CR/CRi and receive maintenance
therapy on this study.
IV. To define cellular factors associated with clinical response to GO/vorinostat and
determine the mechanisms underlying the synergistic effect between GO and vorinostat on
primary AML cells (in vitro correlative and mechanistic studies).
OUTLINE:
REMISSION INDUCTION THERAPY: Patients receive oral vorinostat once daily on days 1-9 and
gemtuzumab ozogamicin IV over 2 hours on day 8. Treatment repeats every 15-22 days for up to
3 courses.
CONSOLIDATION THERAPY: Beginning within 60 days after the completion of remission induction
therapy, patients receive oral vorinostat once daily on days 1-9 and gemtuzumab ozogamicin
IV over 2 hours on day 8.
MAINTENANCE THERAPY: Patients receive oral vorinostat once daily on days 1-14. Treatment
repeats every 28 days for 4 courses.
All treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for up to 3
years.
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