Alliance A041501 (Leukemia) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find out if it is better, the same, or worse adding the study drug Inotuzumab to the usual chemotherapy than getting chemotherapy alone.
What is the Condition Being Studied?
B-Cell Acute Lymphoblastic Leukemia

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

Age Group

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.

Study Details

Full Title
Alliance A041501: A Phase III Trial to Evaluate the Efficacy of the Addition of Inotuzumab Ozogamicin (a Conjugated Anti-CD22 Monoclonal Antibody) to Frontline Therapy in Young Adults (ages 18-39 Years) with Newly Diagnosed Precursor B-Cell ALL
Principal Investigator
Medical Oncologist
Protocol Number
IRB: PRO00084507
NCT: NCT03150693
Phase III
Contact the Duke Recruitment Innovation Center