Clinical Trial TitleA 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.
Clinical Trial Protocol Description:
This partially randomized phase III trial studies the side effects of inotuzumab ozogamicin and how well it works when given with frontline chemotherapy in treating patients with newly diagnosed B acute lymphoblastic leukemia. Monoclonal antibodies, such as inotuzumab ozogamicin, may block cancer growth in different ways by targeting certain cells. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving inotuzumab ozogamicin with chemotherapy may work better in treating young adults with B acute lymphoblastic leukemia.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Have newly diagnosed CD-22 positive B-cell acute lymphoblastic leukemia (WHO criteria).
- Have no prior therapy except for limited treatment (< 7 days) with corticosteroids or hydroxyurea and a single dose of intrathecal cytarabine.
- Have prior therapy for acute leukemia except emergency therapy (corticosteroids or hydroxyurea) for blast cell crisis, superior vena cava syndrome, or renal failure due to leukemic infiltration of the kidneys; when indicated, leukapheresis or exchange transfusion is recommended to reduce the WBC.
- Have completion of remission induction therapy.
You will be excluded from the study if any of the following criteria apply to you:
- Have BCR-ABL fusion transcript determined by fluorescence in situ hybridization (FISH) or real time-polymerase chain reaction (RT-PCR) or t(9;22)(q34;q11) by cytogenetics.
- Have Burkitt type ALL.
- Have down syndrome.
- Are pregnant or nursing.
This is a partial list of inclusion and exclusion criteria.