Acute Lymphoblastic Leukemia and Localized Lymphoblastic Lymphoma Treatment with Blinatumomab as part of Chemotherapy – Phase III

AALL1731: A Study to Compare the Addition of Blinatumomab in Combination with Chemotherapy in Patients Diagnosed with Standard-risk B-cell Acute Lymphoblastic Leukemia, and the Treatment of Patients with Localized B-cell Lymphoblastic Lymphoma

Protocol Description

Through this multi-center Children’s Oncology Group study, researchers are investigating how well blinatumomab works in combination with standard chemotherapy in treating patients with newly diagnosed, standard-risk B-cell acute lymphoblastic leukemia (B-ALL) or localized B-cell lymphoblastic lymphoma (B-LLy). Monoclonal antibodies, such as blinatumomab, may induce changes in the body's immune system and may help to interfere with the ability of cancer cells to grow and spread.

Study Level: III

Eligibility Criteria

Subject to certain exclusion criteria, this study is enrolling pediatric patients who have a newly diagnosed standard-risk B-ALL or localized B-LLy.
Males and Females: Ages 1 through 9 for participants with B-ALL, and ages 1 through 30 for those with B-LLy

Requirements

The first phase of the trial, called the induction phase, lasts 5 weeks and uses a combination of chemotherapy drugs to remove visible signs of leukemia. In the consolidation phase that follows, additional chemotherapy is administered over 56 days for B-ALL participants and 28 for days for B-LLy participants. Following that, participants are either assigned or randomized to subsequent study arms, some of which introduce the study drug blinatumomab as part of chemotherapy that is administered in repeating cycles for up to 2 years and 4 months.
Visits: Number of visits will vary based on disease and treatment arms.
Duration: Approximately 2-1/2 years depending on treatment path and participant response to therapy in most cases.

Status: Enrolling by Invitation

Source(s) of Support

Children’s Oncology Group (AALL1731)
National Cancer Institute

Primary Investigator

Erika Friehling, MD

Contact Information

For more information about the study or enrollment, please contact the UPMC Children’s Hospital of Pittsburgh Hematology-Oncology research team, at:
HOCHPPhaseI-II@upmc.edu.