Clinical Trial

Young Adults with Acute Lymphoblastic Leukemia

Study Description

Inotuzumab Ozogamicin and Frontline Chemotherapy in Treating Young Adults With Newly Diagnosed B Acute Lymphoblastic Leukemia

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.

Location

Locations Selected Location

Methods

Pharmaceutical medication involved Pharmaceutical medication involved
Recruiting patients only Recruiting patients only

Drug - Allopurinol

Given PO

Drug - Cytarabine

Given IT, IV, SC

Drug - Daunorubicin Hydrochloride

Given IV

Drug - Vincristine Sulfate

Given IV

Drug - Dexamethasone

Given PO or IV

Drug - Pegylated L-Asparaginase

Given IV

Drug - Methotrexate

Given IT, IV, PO

Procedure - Bone Marrow Aspiration and Biopsy

Undergo bone marrow aspiration and biopsy

Drug - Cyclophosphamide

Given IV

Drug - Mercaptopurine

Given PO

Biological - Rituximab

Given IV

Drug - Doxorubicin

Given IV

Drug - Thioguanine

Given PO

Biological - Inotuzumab Ozogamicin

Given IV

Laboratory Biomarker Analysis

Correlative studies

Additional Information

Official Study Title

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

Clinical Trial ID

NCT03150693

ParticipAid ID

xe7qjb