A Phase II Study of CLAG Regimen Combined With Imatinib Mesylate for Relapsed or Refractory Acute Myeloid Leukemia |
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| Institution: | 1. Department of Internal Medicine, University of South Florida, Tampa, FL;2. Department of Malignant Hematology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL;3. H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL;1. Department of Oncology, The First Affiliated Hospital of Anhui Medical University, Anhui, China;2. Department of Oncology, Huangshan City People’s Hospital, Huangshan, Anhui, China;3. Department of Respiratory Medicine, Huangshan City People’s Hospital, Huangshan, Anhui, China;1. Department of Molecular Pathology, The Affiliated Cancer Hospital of Zhengzhou University, 450000 Zhengzhou, China;2. Henan Cancer Institute, 450000 Zhengzhou, China;1. Department of Molecular Pathology, The Affiliated Cancer Hospital of Zhengzhou University, 450000 Zhengzhou, China;2. Henan Cancer Institute, 450000 Zhengzhou, China;1. Department of Molecular Pathology, The Affiliated Cancer Hospital of Zhengzhou University, 450000 Zhengzhou, China;2. Henan Cancer Institute, 450000 Zhengzhou, China;1. Department of Epidemiology, College of Public Health, University of Iowa, Iowa City, IA;2. Holden Comprehensive Cancer Center, University of Iowa, Iowa City, IA;3. Department of Internal Medicine, Mayo Clinic, Rochester, MN;4. Department of Internal Medicine, Carver College of Medicine, University of Iowa, Iowa City, IA;1. Sunnybrook Odette Cancer Center, Toronto, ON M4N 3M5, Canada |
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| Abstract: | IntroductionNo standard salvage chemotherapy regimen is available for relapsed or refractory (RR) acute myeloid leukemia (AML). Preclinical data have suggested synergy in vitro between cytarabine and imatinib mesylate (IM) on AML cell growth inhibition. After demonstrating the safety and feasibility in a phase I study, we conducted a phase II clinical study of CLAG (cladribine, cytarabine, granulocyte colony-stimulating factor) regimen combined with IM for patients with RR-AML.Patients and MethodsWe performed a single-institution 2-stage phase II study. The primary endpoint was the remission rate measured using the standard AML response criteria. The secondary endpoints included overall survival (OS) and progression-free survival (PFS).ResultsFrom August 2009 to April 2011, 38 patients were treated at the Moffitt Cancer Center. Their median age was 62 years (range, 26-79 years). Of the 38 patients, 7 (18%) had refractory AML, 19 (50%) had early relapse, and 12 (32%) had late relapse. At the original diagnosis, only 2 patients had favorable risk factors, 18 had intermediate risk, and 16 had poor risk; for 2 patients, the karyotype was missing. The overall response rate for all 38 evaluable patients was 37%. The median OS was 11.1 months (95% CI, 4.8-13.4 months), the median PFS was 4.9 months (95% CI, 1.6-11.7 months). Among the responders, 8 of 14 patients subsequently underwent allogeneic hematopoietic cell transplantation.ConclusionCLAG plus IM was well tolerated, with encouraging signs of activity in patients with poor-risk AML. |
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| Keywords: | C-kit Imatinib Refractory leukemia Relapsed leukemia Salvage therapy |
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