Clinical Development of Oblimersen for Acute Myeloid Leukemia
المؤلف:
Hoffman, R., Benz, E. J., Silberstein, L. E., Heslop, H., Weitz, J., & Salama, M. E.
المصدر:
Hematology : Basic Principles and Practice
الجزء والصفحة:
8th E , P196-197
2025-11-15
7
The safety and efficacy of oblimersen was initially investigated in combination with FLAG (fludarabine, cytarabine, and granulocyte colony-stimulating factor) in a phase I study including 17 patients with refractory or relapsed AML. Seven patients had a response, and no dose-limiting toxicity was observed, leading to a subsequent phase I trial of the combination of oblimersen, cytarabine, and dau norubicin in 29 patients with previously untreated AML. Fourteen patients experienced remission, 7 of whom later had disease relapse, and no significant toxicity was observed. Of interest, after a 72-hour infusion of this combination, BCL2 mRNA copies were significantly decreased from baseline in patients who went on to have remission. A phase II study further explored the efficacy of oblimersen in combination with gemtuzumab ozogamicin in older patients with AML at time of first relapse. This study showed a remission rate of 25% and durable responses. Despite its clinical activity and limited toxicity, the clinical development of oblimersen has not moved forward, mainly because it requires weekly continuous infusions.
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