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

This 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. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a chemotherapy drug called ozogamicin. Inotuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as CD22 receptors, and delivers ozogamicin to kill them. Chemotherapy drugs, such as \[intervention\], work in different ways to stop the growth

Trial Details

NCT ID

NCT03150693

Phase

PHASE3

Sponsor

Alliance for Clinical Trials in Oncology

Status

RECRUITING

Cancer Type

Leukemia

Interventions

Allopurinol
Cytarabine
Daunorubicin Hydrochloride
Vincristine Sulfate
Dexamethasone
Pegylated L-Asparaginase

Locations (sample)

Birmingham, Alabama, United States|33.52066,-86.80249
Anchorage, Alaska, United States|61.21806,-149.90028
Anchorage, Alaska, United States|61.21806,-149.90028
Anchorage, Alaska, United States|61.21806,-149.90028
Anchorage, Alaska, United States|61.21806,-149.90028

Key Eligibility 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 NO…
REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Single-dose intrathecal cytarabine is allowed prior to registration or prior to initiation of systemati…
REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Age \>= 18 years and \< 40 years

For full eligibility, visit ClinicalTrials.gov.

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