Failure of three novel regimens to improve outcome for patients with relapsed or refractory acute myeloid leukaemia: a report from the Eastern Cooperative Oncology Group
Year: 2009
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
Abstract: The treatment of relapsed acute myeloid leukaemia (AML) remains unsatisfactory. We conducted a phase II randomized trial where patients received intermediate-dose cytarabine for 4 d followed by gemtuzumab ozogamicin on day 5 (Arm A), or combined with liposomal daunorubicin for 3 d (Arm B), or cytarabine given for 5 d combined with cyclophosphamide for 3 d and topotecan by continuous infusion for 5 d (Arm C). Eligible patients had primary refractory AML, a first relapse after a remission of <1 year, or a second or greater relapse. The primary objective of this trial was attainment of a conventional complete remission (CR) or a CR without platelet recovery (CRp) in at least 40% of patients. The CR/CRp rates for the 82 eligible patients were 3/26 (12%) in Arm A, 2/29 (7%) in Arm B, and 1/27 (4%) in Arm C. No patients who had relapsed within 6 months of initial CR or who had suffered multiple relapses responded. More than 95% of patients subsequently died of AML. No unexpected toxicities were encountered. We conclude that none of these three regimens were effective enough in the treatment of high-risk relapsed or refractory AML to warrant further study. This trial was registered at http://www.clinicaltrials.gov as #NCT00005962.
Source: British Journal of Haematology
Institutions: Mayo Clinic, Dana-Farber Cancer Institute, Johns Hopkins University, Sidney Kimmel Comprehensive Cancer Center, University Hospitals Cleveland Medical Center, University Hospitals Seidman Cancer Center, University of Rochester Medicine, University of Rochester, Lady of Mercy Medical Center, Rambam Health Care Campus, Northwestern University, Robert H. Lurie Comprehensive Cancer Center of Northwestern University
Language: English
Subfield: Hematology
Field: Medicine
Domain: Health Sciences
Open Access status: green
Awards: G1011812605, G1257575315, Eastern Cooperative Oncology Group, ECOG Statistical Office Data Management Grant, G1422427855, G2017411191, EASTERN COOPERATIVE ONCOLOGY GROUP, G286468852, Eastern Cooperative Oncology Group, ECOG Clinical Trials, G4412485521, Southwest Oncology Group, Eastern Cooperative Oncology Group Studies, G5765316850, G631691829, Eastern Cooperative Oncology Group, ECOG Specimen Banking, ECOG Statistical Office, Eastern Cooperative Oncology Group Operations Office, G92717670, G964706321
OpenAlex ID: W2010655738