A randomized controlled trial comparing peginterferon-α-2a versus observation after stopping tyrosine kinase inhibitor in chronic myeloid leukemia patients with deep molecular response for at least two years

Abstract

BackgroundInterferon (IFN) is a logical possibility to increase treatment free remission (TFR) rate in chronic myeloid leukemia (CML). We conducted the first randomized controlled trial comparing the use of pegIFN versus observation in CML patients attempting TFR.MethodsAdult CML patients with stable deep molecular response for ≥ 2 years with ≥ 2 readings of MR4.5 were randomized into two arms -- subcutaneous pegIFN-α-2a starting at 180 µg weekly for a year, followed by observation, or observation.ResultsA total of 30 patients were recruited (pegIFN n = 15, observation n = 15). Median follow-up was 38.1 months (range 15.9–49.4) and 23.8 (1.5–51.0) in pegIFN and observation arm, respectively. A total of 11 patients relapsed (pegIFN n = 4, observation n = 7). The median time of relapse was 13.1 months (range 9.2 to 25.5) and 4.4 (1.2 to 13.6) in pegIFN and observation arm, respectively. Only 8 out of 15 (53%) patients completed 52 doses of pegIFN with mean dose of 43 out of 52 doses (range 20 to 52). Dose of tolerable pegIFN was age dependent.ConclusionPegIFN is a potential consolidative therapy to increase TFR.Trial registration:(1) Malaysia National Medical Research Register (NMRR): NMRR-13-1186-15491. Approved 23rd September 2014, https://www.nmrr.gov.my/fwbLoginPage.jsp(2) ClinicalTrials.gov: NCT02381379. Registered on 24th Feb 2015, https://clinicaltrials.gov/ct2/results?cond=&term=NCT02381379&cntry=&state=&city=&dist=