This phase 3 clinical trial will test the effectiveness of blinatumomab (Blincyto) with chemotherapy versus chemotherapy alone in treating patients with newly diagnosed B lineage acute lymphoblastic leukemia (ALL) that is BCR-ABL negative. The primary outcome will be measured by the overall survival.
The details
Blinatumomabis an immunotherapy that uses the body’s own immune system to identify and kill cancerous B-cells. It is an antibody (a protein in the immune system) that binds to a protein found on cancerous B-cells, which allows other parts of the immune system to identify the cells as cancerous and start an attack. It is unclear whether adding blinatumomab to a standard chemotherapy will improve the response rate.
The study will examine the overall survival for 10 years. Negative events, relapse-free survival, and minimal residual disease (few cancer cells remain in the body) will also be considered.
Who are they looking for?
This trial is recruiting 360 patients with BCR-ABL negative (Philadelphia chromosome negative) B-cell lineage ALL. Patients should have adequate organ function and should not have a prior blood disorder. Participants cannot have another malignancy requiring treatment or mature B-Cell ALL. Both men and women must use contraception for up to 3 months following the end of treatment.
Patients should not have any disorder involving the central nervous system, or a recent history of heart attack or heart failure. Patients must not have an active infection.
How will it work
Patients will initially be given an induction combination chemotherapy, containing intravenous (IV, infused directly into a vein), oral, and subcutaneous (injection under the skin) agents, which will be given over the course of 42 days. Four weeks after induction, patients will move onto intensification therapy where high-dose methotrexate (Trexall) will be given on days 1 and 8 by IV, and pegaspargase (Oncaspar) on day 9 of the therapy.
After intensification, patients will be randomized into two groups. One group will receive intravenous blinatumomab (on days 1-28 of a 6 week cycle for 2 cycles) then either undergo an allogeneic stem cell transplant (transplant of donor stem cells) or proceed to a consolidation phase. Consolidation will begin during the second blinatumomab cycle and contain a combination chemotherapy. The group that does not receive blinatumomab with either undergo allogeneic stem cell transplantation or receive the consolidation chemotherapy only. All patients who respond well to treatment will be able to undergo a maintenance therapy for up to 2.5 years.
Following treatment, patients will be followed every 3 months for 2 years, every 6 months for 3 years, and then every 12 months for 5 years.
