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
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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Probability of achieving CR or CRi with induction therapy (Good-risk group)
After completion of induction therapy
No
Roland Walter
Principal Investigator
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Institutional Review Board
2200.00
NCT00673153
March 2008
Name | Location |
---|---|
Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
Stanford University | Stanford, California 94305 |
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle, Washington 98109 |
Wake Forest University Health Sciences | Winston-Salem, North Carolina 27157 |