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Improved leukemia-free survival after postconsolidation immunotherapy with histamine dihydrochloride and interleukin-2 in acute myeloid leukemia: results of a randomized phase 3 trial

Journal article
Authors Mats Brune
Sylvie Castaigne
John Catalano
Kurt Gehlsen
Anthony D Ho
Wolf-Karsten Hofmann
Donna E Hogge
Bo Nilsson
Reuven Or
Ana Romero
Jacob M Rowe
Bengt Simonsson
Ruth Spearing
Edward A Stadtmauer
Jeff Szer
Elisabeth Wallhult
Kristoffer Hellstrand
Published in Blood
Volume 108
Issue 1
Pages 88-96
ISSN 0006-4971 (Print)
Publication year 2006
Published at Institute of Biomedicine, Department of Infectious Medicine
Pages 88-96
Language en
Keywords Acute Disease, Adolescent, Adult, Aged, Aged, 80 and over, Disease-Free Survival, Female, Histamine/adverse effects/ therapeutic use, Humans, Immunotherapy, Interleukin-2/adverse effects/ therapeutic use, Leukemia, Myeloid/ therapy, Male, Middle Aged, Proportional Hazards Models, Recurrence, Remission Induction, Survival Rate, Treatment Outcome
Subject categories Medical and Health Sciences


The primary objective of this phase 3 study was to determine whether postconsolidation immunotherapy with interleukin-2 (IL-2) and histamine dihydrochloride (HDC) improved the leukemia-free survival (LFS) of adult patients with acute myeloid leukemia (AML) in complete remission (CR). Three hundred twenty patients with AML (median age, 57 years; range, 18-84 years) were stratified by CR1 or subsequent CR (CR > 1) and randomly assigned to treatment with HDC/IL-2 or no treatment (control). Treatment comprised 10 21-day cycles with IL-2 (16 400 U/kg) plus HDC (0.5 mg); both compounds were administered by subcutaneous injection twice daily. Study arms were balanced for age, sex, previous treatment, leukemic karyotypes, time from CR to inclusion, and frequency of secondary leukemia. Three years after enrollment of the last patient, treatment with HDC/IL-2 was found to improve LFS over control in the study population (CR1 + CR > 1, n = 320; P < .01, log-rank test). For patients in CR1 (n = 261), treatment significantly improved LFS (P = .01) with 3-year LFS estimates of 40% (HDC/IL-2) compared with 26% (control). Side effects were typically mild to moderate. These results indicate that HDC/IL-2 treatment offers an efficacious and tolerable treatment for patients with AML in remission.

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