HEALTH PROFESSIONAL · SOURCE READING
Blinatumomab followed by allogeneic BMT
Source: Acute Lymphoblastic Leukemia Treatment (PDQ®)–Health Professional Version, National Cancer Institute.
Source updated: March 17, 2025 · Captured 2026-09-09.
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Context: Treatment of Recurrent ALL / Treatment Options for Recurrent ALL
Blinatumomab is a bispecific antibody targeting CD19 and CD3. The U.S. Food and Drug Administration (FDA) has approved blinatumomab for use in patients with relapsed or refractory B-cell ALL.
Evidence (blinatumomab):
A randomized phase III study of blinatumomab versus one of four standard reinduction regimens was conducted in patients with primary refractory disease, which was refractory to salvage, with a first relapse lasting fewer than 12 months, a second or greater relapse, or any relapse after allogeneic transplant.[9] The four regimens included the following: fludarabine, high-dose cytosine arabinoside, and granulocyte colony-stimulating factor with or without anthracycline; a high-dose cytosine arabinoside–based regimen; a high-dose methotrexate-based regimen; or a clofarabine-based regimen.
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A randomized phase III study of blinatumomab versus one of four standard reinduction regimens was conducted in patients with primary refractory disease, which was refractory to salvage, with a first relapse lasting fewer than 12 months, a second or greater relapse, or any relapse after allogeneic transplant.[9] The four regimens included the following: fludarabine, high-dose cytosine arabinoside, and granulocyte colony-stimulating factor with or without anthracycline; a high-dose cytosine arabinoside–based regimen; a high-dose methotrexate-based regimen; or a clofarabine-based regimen.
Remission rates were 43.9% for the blinatumomab-treated group versus 24.6% in the standard-treatment group (odds ratio, 2.40; 95% confidence interval [CI], 1.51–3.80).
A randomized phase III study of blinatumomab versus one of four standard reinduction regimens was conducted in patients with primary refractory disease, which was refractory to salvage, with a first relapse lasting fewer than 12 months, a second or greater relapse, or any relapse after allogeneic transplant.[9] The four regimens included the following: fludarabine, high-dose cytosine arabinoside, and granulocyte colony-stimulating factor with or without anthracycline; a high-dose cytosine arabinoside–based regimen; a high-dose methotrexate-based regimen; or a clofarabine-based regimen.
Overall survival (OS) was superior in the blinatumomab-treated group (7.7 months vs. 4.0 months in the standard-treatment group), with a hazard ratio (HR) of .71 (95% CI, 0.55–0.93), favoring blinatumomab.
A randomized phase III study of blinatumomab versus one of four standard reinduction regimens was conducted in patients with primary refractory disease, which was refractory to salvage, with a first relapse lasting fewer than 12 months, a second or greater relapse, or any relapse after allogeneic transplant.[9] The four regimens included the following: fludarabine, high-dose cytosine arabinoside, and granulocyte colony-stimulating factor with or without anthracycline; a high-dose cytosine arabinoside–based regimen; a high-dose methotrexate-based regimen; or a clofarabine-based regimen.
Adverse events occurred at similar rates in both groups, and the only unique side effect of blinatumomab was cytokine-release syndrome, which was seen in 4.9% of patients.
Blinatumomab should be considered as an option for reinduction therapy for patients with primary refractory disease, which is refractory to salvage, with a first relapse lasting fewer than 12 months, a second or greater relapse, or any relapse after allogeneic transplant.[9][Level of evidence A1]
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