Phase I/II Study of the Combination of Mitoxantrone, Etoposide and Gemtuzumab Ozogamicin for Patients With Acute Myeloid Leukemia Refractory to Initial Standard Induction Therapy (UPCI 07-154)
The combination of mitoxantrone and etoposide is an active regimen in refractory/relapsed
AML patients. In order to improve the efficacy of mitoxantrone and etoposide as second line
therapy in patients with AML we proposed to conduct a phase I/II clinical trial combining
gemtuzumab ozogamicin with mitoxantrone and etoposide. The phase I portion of the trial will
determine the maximum tolerated dose of gemtuzumab ozogamicin combined with mitoxantrone and
etoposide and the phase II portion of the trial will determine the efficacy and safety of
the combined regimen in patients with AML.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To evaluate the toxicity and response rate of the combination therapy of mitoxantrone, etoposide and gemtuzumab ozogamicin as second line therapy in patients with acute myeloid leukemia (AML).
Bone marrow biopsy and aspiration 14 days after gemtuzumab ozogamicin administration, to evaluate response to the study drug regimen.
Michael Boyiadzis, MD
University of Pittsburgh
United States: Institutional Review Board
|University of Pittsburgh Cancer Institute / Hillman Cancer Center||Pittsburgh, Pennsylvania 15232|