Bortezomib and Doxil for the Treatment of Patients With Acute Myelogenous Leukemia
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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)|
- Progression Free Survival [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]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.
- Overall Survival [ Time Frame: Up to two years ] [ Designated as safety issue: No ]Overall survival wil be measured as the time from start of treatment to the Date of death or the last date the patient was known to be alive
- Toxicity [ Time Frame: Up to two years ] [ Designated as safety issue: Yes ]Toxicity will be evaluated based on the standard NCI Common Toxicity Criteria for Adverse Effects CTCAE) V.4.0 grading criteria.
|Study Start Date:||December 2012|
|Estimated Study Completion Date:||March 2017|
|Estimated Primary Completion Date:||January 2016 (Final data collection date for primary outcome measure)|
Experimental: Bortezomib + Doxil
Bortezomib will be given subcutaneously at 1.5mg/m2 on days 1, 4, 8 and 11 of a 3 week cycle. Doxil will be administered once every three weeks as a single intravenous infusion at a dose of 40 mg/m2 (day 4 of each cycle).
Bortezomib will be given twice a week subcutaneously (under the skin) for two weeks in every 3 week cycle.
Other Name: VelcadeDrug: Doxil
Doxil or LipoDox will also be given through a venous catheter (inside your vein). Doxil or LipoDox will be given over 60 to 90 minutes on Day 4 of every 21-day cycle.
Other Name: LipoDox; pegylated liposomal doxorubicin
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01736943
|Contact: Corinne Turrell||916-734-3089|
|United States, California|
|University of California Comprehensive Cancer Center||Recruiting|
|Sacramento, California, United States, 95817|
|Contact: Clinical Trials Navigator 916-734-3089|
|Principal Investigator: Joseph Tuscano, MD|
|Principal Investigator:||Joseph Tuscano, MD||University of California, Davis|