A Randomized Study Of The Safety And Efficacy Of Two Dose Schedules Of Gemcituzumab Ozogamicin In Patients With Intermediate-2 Or High-Risk Myelodysplastic Syndromes
OBJECTIVES: I. Determine the total survival of patients with intermediate-2 or high-risk
myelodysplastic syndrome treated with gemtuzumab ozogamicin. II. Assess the quality of life
of patients treated with this drug. III. Compare two different dose schedules of this drug
in these patients. IV. Determine the safety of this drug in these patients. V. Determine the
number of patients treated with this drug that achieve complete remission, partial
remission, stable disease, major and minor hematologic improvements, or major and minor
cytogenetic responses. VI. Determine the progression-free survival, relapse-free survival,
and time to progression to acute myeloid leukemia in patients treated with this drug. VII.
Determine the number of transfusions, number of days on IV antibiotics, and the number of
days hospitalized in patients treated with this drug. VIII. Determine the possible
predictors of response in patients treated with this drug, including age, karyotype, and
multi-drug resistance efflux. IX. Determine the pharmacokinetics of this drug in these
patients. X. Correlate the results of pharmacogenomic studies to gene activation and
response to therapy in patients treated with this drug.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified
according to age (60 and under vs over 60) and IPSS score (1.5-2.0 vs 2.5 and greater).
Patients are randomized to one of two treatment arms. Arm I: Patients receive gemtuzumab
ozogamicin IV over 2 hours on day 1. Arm II: Patients receive gemtuzumab ozogamicin IV over
2 hours on days 1 and 15. After completion of induction therapy, patients in both arms with
stable or responding disease may receive post-remission therapy comprising up to 3
additional doses of gemtuzumab ozogamicin approximately 28-42 days apart. Quality of life is
assessed at baseline, on day 29 for arm I, on day 43 for arm II, on day 127 for patients
that receive additional doses of study drug, and at 8 months for all patients. Patients who
do not respond to induction therapy are followed monthly for 8 months and then every 3
months thereafter. Patients who receive post-remission therapy are followed every 3 months.
PROJECTED ACCRUAL: Approximately 128 patients (64 per treatment arm) will be accrued for
this study within 12 months.
Primary Purpose: Treatment
Gary J. Schiller, MD
Jonsson Comprehensive Cancer Center
United States: Federal Government
|Jonsson Comprehensive Cancer Center, UCLA||Los Angeles, California 90095-1781|