Phase 3 Study of Study to Evaluate Marqibo® in the Combination Chemotherapy in the Treatment of Subjects >or=60 Years Old With Newly Diagnosed Acute Lymphoblastic Leukemia (ALL)
A phase 3, multicenter, randomized study to evaluate the substitution of Marqibo®
(Vincristine Sulfate Liposomes Injection, VSLI) for standard Vincristine Sulfate Injection
(VSI) in the induction, intensification, and maintenance phases of combination chemotherapy
in the treatment of subjects >or= 60 years old with newly diagnosed acute lymphoblastic
leukemia (ALL).
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary Efficacy Criterion
Overall Survival will be measured for all subjects from the date of randomization until death from any cause.
24 months of Sequential Induction
Yes
Susan M O'Brien, MD
Principal Investigator
MD Anderson
United States: Food and Drug Administration
TTX404
NCT01439347
March 2012
August 2017
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |
Washington University School of Medicine | Saint Louis, Missouri 63110 |
Western Pennsylvania Hospital | Pittsburgh, Pennsylvania 15224 |
Hackensack University Medical Center | Hackensack, New Jersey 07601 |
Seattle Cancer Care Alliance | Seattle, Washington 98109 |
Duke University Medical Center | Durham, North Carolina 27710 |
Cleveland Clinic | Cleveland, Ohio 44195 |
University of Chicago | Chicago, Illinois 60637 |
UCLA | Los Angeles, California 90095 |
Karmanos Cancer Institute | Detroit, Michigan 48201 |
Nebraska Medical Center | Omaha, Nebraska 68198 |
The University of Texas, M.D. Anderson Cancer Center | Houston, Texas 77030 |
Emory University, Winship Cancer Institute | Atlanta, Georgia 30322 |
Cornell | New York, New York |
UC San Diego Moores Cancer Center | La Jolla, California 92093 |
Northwestern University Fienberg School of Medicine | Chicago, Illinois 60611 |