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Phase 3 randomized study to evaluate the substitution of Marqibo for standard vincristine sulfate injection in combination chemotherapy for subjects ≥ 60 yrs old w/ newly diagnosed ALL

Study Status

Open to Enrollment

Study Description

This clinical trial is for men and women with newly diagnosed acute lymphoblastic leukemia (ALL) who are age 60 or older. The purpose of this study is to determine the effectiveness and safety of an experimental drug called Marqibo in treating ALL.

Marqibo is a new anticancer drug. It combines Vincristine sulfate, an FDA-approved anticancer drug, and packages it into a small fat bubble known as a liposome. The goal is to improve the drug’s ability to destroy cancer cells and help reduce the potential side effects of treatment.

The study will compare giving a combination of drugs which will include either Vincristine sulfate (VSI) or Marqbo to treat ALL. Some study participants will receive combination chemotherapy containing Vincristine sulfate (VSI) and others will receive combination chemotherapy containing Marqibo.

Study participants will be randomly assigned to one of two study groups:

• Group 1: combination chemotherapy (cyclophosphamide, daunorubicin) containing standard vincristine sulfate (VSI)
• Group 2: combination chemotherapy (cyclophosphamide, daunorubicin) containing Mariqbo (vincristine sulfate liposomes injection, VSLI)

Participants will receive treatment for up to 24 months or until disease progression. 

Disease Status and/or Stage

Newly Diagnosed ALL, Age 60 and Older

Sponsor

Talon Therapeutics

Key Eligibility

• Age 60 or older
• Newly diagnosed ALL
• No prior systemic chemotherapy for ALL
• No prior treatment with vincristine

Principal Investigator

Gail Roboz, MD

Contact

• Tania Curcio, RN
• (212) 746-2571
• [email protected]