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Brief Title: A Phase 3 Study to Evaluate Marqibo® in the Treatment of Subjects ≥ 60 Years Old With Newly Diagnosed ALL
Official Title: 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)
Study ID: NCT01439347
Brief Summary: A phase 3 study in the treatment of subjects \>or= 60 years old with newly diagnosed acute lymphoblastic leukemia (ALL).
Detailed Description: 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).
Minimum Age: 60 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
UC San Diego Moores Cancer Center, La Jolla, California, United States
UCLA, Los Angeles, California, United States
Emory University, Winship Cancer Institute, Atlanta, Georgia, United States
Northwestern University Fienberg School of Medicine, Chicago, Illinois, United States
University of Chicago, Chicago, Illinois, United States
Karmanos Cancer Institute, Detroit, Michigan, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Nebraska Medical Center, Omaha, Nebraska, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Cornell, New York, New York, United States
Duke University Medical Center, Durham, North Carolina, United States
Cleveland Clinic, Cleveland, Ohio, United States
The University of Texas, M.D. Anderson Cancer Center, Houston, Texas, United States
Seattle Cancer Care Alliance, Seattle, Washington, United States
Name: Susan M O'Brien, MD
Affiliation: MD Anderson
Role: PRINCIPAL_INVESTIGATOR