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
Alliance for Clinical Trials in Oncology
Summary
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.
Description
PRIMARY OBJECTIVES: I. To confirm tolerability of the combination regimen with the addition of inotuzumab ozogamicin to the pediatric-inspired regimen of cancer and leukemia group B (CALGB) 10403. II. To determine whether the addition of inotuzumab ozogamicin significantly improves the event-free survival (EFS) in patients who achieve an induction response achieved with the pediatric-inspired regimen of CALGB 10403, without censoring for transplant. (Phase III) SECONDARY OBJECTIVES: I. To determine the impact of inotuzumab ozogamicin on disease-free (DFS) and overall survival (OS) in patie…
Eligibility
- Age range
- 18–39 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: REGISTRATION ELIGIBILITY CRITERIA (STEP 1) * Newly diagnosed patients with CD-22 positive B-cell acute lymphoblastic leukemia (WHO criteria) are eligible. Patients with Burkitt type ALL are NOT eligible * Patients who 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 are not eligible and should be considered for enrollment on studies that incorporate imatinib during induction; please note: flow cytometry is to be performed at the local reference lab and…
Interventions
- DrugAllopurinol
Given PO
- DrugCytarabine
Given IT, IV, SC
- DrugDaunorubicin Hydrochloride
Given IV
- DrugVincristine Sulfate
Given IV
- DrugDexamethasone
Given PO or IV
- DrugPegylated L-Asparaginase
Given IV
- DrugMethotrexate
Given IT, IV, PO
Locations (460)
- University of Alabama at Birmingham Cancer CenterBirmingham, Alabama
- Anchorage Associates in Radiation MedicineAnchorage, Alaska
- Anchorage Radiation Therapy CenterAnchorage, Alaska
- Alaska Breast Care and Surgery LLCAnchorage, Alaska
- Alaska Oncology and Hematology LLCAnchorage, Alaska
- Alaska Women's Cancer CareAnchorage, Alaska