Mark R. Litzow, MD, discusses the methods and design used in the ECOG-ACRIN E1910 trial.
Mark R. Litzow, MD, professor of medicine in the Division of Hematology at the Mayo Clinic, discusses the methods and design from the ECOG-ACRIN E1910 trial (NCT02003222).
In the study, experts evaluated blinatumomab (Blincyto) when added to chemotherapy vs chemotherapy alone for the treatment of patients with B-cell precursor acute lymphoblastic leukemia (ALL).
Transcription:
0:09 | In my presentation, I presented a study that I had the privilege of leading. It is called the E1910 trial through the ECOG-ACRIN Cooperative Group. This was a National Clinical Trials Network intergroup trial in the United States. We took patients between the ages of 30 and 70 with B-cell precursor ALL, and we enrolled 488 of these patients. These patients were Philadelphia chromosome-negative, and we gave them 2 months of induction chemotherapy. If patients achieved a conventional morphologic complete remission, they stayed on study. If they did not, they went off the study.
0:55 | We had an 81% complete remission rate. They then got an intensification cycle of chemotherapy for [central nervous system] prophylaxis, and then we assessed their measurable residual disease, or MRD status, by flow cytometry. If they were MRD-negative, we randomized them to get the control arm of 4 cycles of conventional consolidation chemotherapy followed by maintenance therapy, or we gave them the same 4 cycles of consolidation chemotherapy, but added 4 cycles of the blinatumomab, which is given by a continuous [intravenous] infusion for 4 weeks.
1:35 | So, those patients got 2 cycles of blinatumomab when they were randomized, then 3 cycles of chemotherapy, then another cycle of blinatumomab, another cycle of chemotherapy, and then the fourth cycle of the blinatumomab. They then went on to maintenance therapy, and again, either group of patients could go onto an allogeneic transplant if their physician felt that was indicated. About 20% of the patients did go for a transplant.
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