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The primary report of Study 0201: adding histamine dihydrochloride to low-dose interleukin-2 after consolidation improved leukaemia-free survival in acute myeloid leukaemia, with 40 percent against 26 percent leukaemia-free at three years in first remission.
Phase 3 trial whose primary objective was to determine whether postconsolidation immunotherapy with interleukin-2 and histamine dihydrochloride improved leukaemia-free survival of adults with acute myeloid leukaemia in complete remission. Three hundred and twenty patients (median age 57 years, range 18 to 84) were stratified by first or subsequent complete remission and randomly assigned to histamine dihydrochloride plus interleukin-2 or no treatment. Treatment comprised ten 21-day cycles of interleukin-2 (16,400 units per kilogram) plus histamine dihydrochloride (0.5 mg), both by subcutaneous injection twice daily. Arms were balanced for age, sex, previous treatment, karyotype, time from remission to inclusion and secondary leukaemia.
Three years after enrolment of the last patient, treatment improved leukaemia-free survival over control in the study population (n = 320; P < .01, log-rank). For patients in first complete remission (n = 261), treatment significantly improved leukaemia-free survival (P = .01) with 3-year estimates of 40 percent versus 26 percent. Side effects were typically mild to moderate.
This is the trial behind the 2008 European authorisation of Ceplene, one of very few maintenance immunotherapies ever approved in acute myeloid leukaemia. The abstract reports no overall survival benefit and the drug is little used today, with oral azacitidine and targeted maintenance filling the space.
Shares Histamine dihydrochloride, Aldesleukin (high-dose IL-2).
Shares Blood, Acute myeloid leukaemia.
Shares Blood, Acute myeloid leukaemia.
Shares Blood, Acute myeloid leukaemia.
Shares Blood, Acute myeloid leukaemia.
Shares Study 0201, Histamine dihydrochloride, Aldesleukin (high-dose IL-2).