At a glance
ClinicalIndex Comparison Record- ✓Newly diagnosed CD-22 positive B-cell acute lymphoblastic leukemia
- ✓WHO criteria B-cell ALL diagnosis
- ✓Limited prior therapy allowed: <7 days corticosteroids or hydroxyurea, single dose intrathecal cytarabine
- ✓Emergency therapy allowed for specific complications
- ✕Burkitt type ALL
- ✕BCR-ABL fusion transcript positive or t(9;22) cytogenetics
- ✕Down syndrome
- ✕M3 or M4 marrow (>25% lymphoblasts) at randomization
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Allopurinol, Cytarabine, and 13 other interventions for B Acute Lymphoblastic Leukemia. Currently recruiting, targeting 310 participants across 460 sites in 2 countries.
Detailed 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.
Study Details
Timeline
Interventions
Given PO
Given IT, IV, SC
Given IV
Given IV
Given PO or IV
Given IV
Given IT, IV, PO
Undergo bone marrow aspiration and biopsy
Given IV
Given PO
Given IV
Given IV
Given PO
Given IV
Correlative studies