CLINICAL TRIAL SUMMARY

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 Status:Open
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
to die.

Asparaginase is designed to deprive the leukemia of a protein needed for cell
growth.

Mercaptopurine and thioguanine are each designed to stop cells from dividing.

Hide details for General InformationGeneral Information

Disease Group:Leukemia
Phase of Study:Phase III
Treatment Agents:6-mercaptopurine
6-Thioguanine
Asparaginase
Cyclophosphamide
Cytarabine
Daunorubicin
Dexamethasone
Doxorubicin
Marqibo
Methotrexate
Prednisone
Vincristine Sulfate
Treatment Location:Both at MDACC & and Other Sites
Estimated Length of Stay in Houston:
Supported By:Talon Therapeutics
Return Visit:
Home Care:


Hide details for Study Contact InformationStudy Contact Information

Physician Name:Susan O'Brien
Dept:Leukemia
For Clinical Trial Enrollment:713-792-7543
For General Questions about Clinical Trials:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)


Show details for Study Objectives / OutcomesStudy Objectives / Outcomes
Show details for Study Status InformationStudy Status Information
Show details for Enrollment EligibilityEnrollment Eligibility
Show details for Resources and LinksResources and Links
Show details for ResultsResults