Bortezomib and Doxil for the Treatment of Patients With Acute Myelogenous Leukemia
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|ClinicalTrials.gov Identifier: NCT01736943|
Recruitment Status : Active, not recruiting
First Posted : November 29, 2012
Last Update Posted : January 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Acute Myelogenous Leukemia||Drug: Bortezomib Drug: Doxil||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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)|
|Study Start Date :||December 2012|
|Estimated Primary Completion Date :||July 2019|
|Estimated Study Completion Date :||December 2019|
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: Velcade
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
- Progression Free Survival [ Time Frame: Up to 2 years ]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 ]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 information recorded will include the type, severity, time of onset, time of resolution, and the probable association with the study regimen. [ Time Frame: Up to two years ]Toxicity will be evaluated based on the standard NCI Common Toxicity Criteria for Adverse Effects CTCAE) V.4.0 grading criteria.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01736943
|United States, California|
|University of California Comprehensive Cancer Center|
|Sacramento, California, United States, 95817|
|Principal Investigator:||Joseph Tuscano, MD||University of California, Davis|