|MDACC Study No:||2011-1071 (clinicaltrials.gov NCT No: NCT01439347)|
|Title:||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 >/= 60 YEARS OLD WITH NEWLY DIAGNOSED ACUTE LYMPHOBLASTIC LEUKEMIA (ALL)|
|Principal Investigator:||Susan O'Brien|
|Treatment Agent:||6-mercaptopurine; 6-Thioguanine; Asparaginase; Cyclophosphamide; Cytarabine; Daunorubicin; Dexamethasone; Doxorubicin; Marqibo; Methotrexate; Prednisone; Vincristine Sulfate|
|Study Description:||The goal of this clinical research study is to compare if and how long Marqibo |
(liposomal vincristine) may be able to help control ALL compared to
vincristine. Participants will also receive standard chemotherapy. The safety
of the combinations will also be studied.
Marqibo is a form of vincristine. Vincristine is designed to interfere with
the multiplication of cancer cells, which may slow or stop their growing and
spreading throughout the body. This may cause the cancer cells to die.
Marqibo is formed when vincristine is placed inside of oil droplets called
liposomes. Marqibo stays in your blood for a longer time than vincristine,
which means it has more time to affect the cancer cells.
Cytarabine is designed to insert itself into DNA (the genetic material of
cells) and stop the DNA from repairing itself.
Cyclophosphamide is designed to interfere with the multiplication of cancer
cells, which may slow or stop their growth and spread throughout the body.
This may cause the cancer cells to die.
Dexamethasone, doxorubicin, methotrexate, daunorubicin, and prednisone are each
designed to stop or slow the growth of cancer cells, which may cause the cells
Asparaginase is designed to deprive the leukemia of a protein needed for cell
Mercaptopurine and thioguanine are each designed to stop cells from dividing.