This phase 3 trial aims to determine the effect of blinatumomab compared to standard chemotherapy in treating patients with B-cell acute lymphoblastic leukemia after a relapse (return of cancer after a period of improvement). The outcome to be measured is the survival rate over 10 years.
Acute lymphoblastic leukemia is a type of cancer where the bone marrow makes too many immature white blood cells. In B-cell leukemia, too many B cells are made. In a relapse, standard treatment may include a combination of chemotherapy or chemotherapy with a stem cell transplant. Blinatumomab is a drug used for the treatment of relapsed acute lymphoblastic leukemia that does not have the Philadelphia chromosome.
The current trial will examine whether blinatumomab is more effective than standard chemotherapy in treating relapsed B-cell acute lymphoblastic leukemia. The main outcome will be measured as the time spent disease free, as well as overall survival.
Who are they looking for?
This study is recruiting 598 participants with a first relapse of acute B-cell lymphoblastic leukemia. Participants should have Philadelphia chromosome negative leukemia. Participants should have recovered from any treatment they received to treat the first incidence of leukemia.
Participants should not have received treatment for the relapse. Participants should not have previously received stem cell transplant. Participants should not have significant kidney disease nor heart disease. Participants should not have Down’s syndrome or any other genetic cause of bone marrow failure. Participants should not have uncontrolled seizures.
How will it work
All patients will receive a combination of drugs including chemotherapy drugs over the initial 4 weeks of the study. They will then be grouped into high, intermediate or low risk groups. Both high and intermediate risk patients will be randomly assigned to 1 of 2 treatment groups. Patients in the first treatment group will receive a combination of chemotherapy over 8 weeks, and then undergo stem cell transplantation. Patients in the second treatment group will receive blinatumomab over 10 weeks before undergoing stem cell transplantation.
Low risk patients will be randomly assigned to 1 of 2 treatment groups. Low risk patients in the first treatment group will receive a combination of chemotherapy drugs for 24 weeks. Low risk patients in the second treatment group will receive treatment alternating between combination of chemotherapy and blinatumomab over 35 weeks.
For all patients, laboratory analysis will be done at the 12th week of the study. Patients will be followed-up every year for 10 years to look at overall survival rate and the occurrence of any relapse.