Phase II Trial of the Combination of Subcutaneous (SQ) Bortezomib and Pegylated Liposomal Doxorubicin (PLD or Doxil or LipoDox) for the Treatment of Patients With Relapsed/Refractory Acute Myelogenous Leukemia (AML)
Acute myeloid leukemia (AML) remains largely incurable despite advances that have been made
in recent years into increasing the complete response (CR) rates. In elderly patients (over
the age of 60), CR rates are lower, 40 to 50%, and long term disease-free and overall
survival is less than 10%. The therapeutic options for relapsed/refractory AML are
significantly limited. Bortezomib has shown promising activity in patients with advanced
hematologic malignancies, including those with leukemia and non-Hodgkin's lymphoma.
Given the available data suggesting efficacy of bortezomib in combination with doxil in
patients with relapsed multiple myeloma (MM), chronic lymphocytic leukemia (CLL), and Non
Hodgkin's lymphoma (NHL) as well as the known sensitivity of AML to anthracyclines and in
vitro data demonstrating the sensitivity of multiply resistant AML cells to bortezomib, we
are proposing the use of this combination in patients with relapsed/refractory AML or
elderly patients who are not candidates for standard induction therapy.
Using the subcutaneous formulation of bortezomib would provide patients with reduced
neurotoxicity and easier schedule due to decreased time in the infusion room and it would
decrease overall cost of care.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression Free Survival
The time from first day of treatment to the first observation of disease progression or death due to any cause. If a patient has not progressed or died, progression-free survival is censored at the time of last follow-up.
Up to 2 years
No
Joseph Tuscano, MD
Principal Investigator
University of California, Davis
United States: Institutional Review Board
UCDCC#230
NCT01736943
December 2012
March 2017
Name | Location |
---|---|
University of California Comprehensive Cancer Center | Sacramento, California 95817 |