Alliance A041501 (Leukemia) - Clinical Trial
What is the Purpose of this Study?
Who Can Participate in the Study?
Adults with newly diagnosed B-cell acute lymphoblastic leukemia who:
- Are 18 or less than 40 years of age
- Have had no prior treatment for acute lymphoblastic leukemia except for limited treatment of less than 7 days
- Do not have Down Syndrome
- Are not pregnant or nursing
What is Involved?
If you choose to join this study, you will:
- Be randomized (put into one of two groups by chance like the flip of a coin) and get either:
-- Group 1: The usual series of leukemia treatments divided into five courses of different combinations of chemotherapy drugs. Depending on the type of ALL, radiation may also be given.
-- Group 2: The usual chemotherapy drugs for this type of cancer plus the study drug inotuzumab. Inotuzumab will be given through a vein in 3 doses over a 28-day period called a cycle for a total of 2 cycles. Depending on the type of ALL, radiation may also be given.
- Be involved in the five courses of chemotherapy for about 3 years, 3 months for males and about 2 years and 3 months for females.
- Get a bone marrow aspirate and biopsy prior to beginning the study and at the end of the chemotherapy courses 1, 2, 4, and 5 to monitor your disease, and if your disease progresses.
- Be followed for up to 10 years after completion of treatment.