title: Randomized study of the combination of hydroxyurea and interferon alpha versus hydroxyurea monotherapy during the chronic phase of chronic myelogenous leukemia (CML Study II). The German CML Study Group.
abstract: It is the long-term goal of the German CML Study Group and of the Süddeutsche Hämoblastosegruppe (SHG) to improve survival of patients with chronic myelogenous leukemia (CML). In a first randomized study (CML Study I) monotherapies with hydroxyurea or interferon alpha (IFN-alpha) were compared with a standard busulfan regimen with regard to duration of the chronic phase and survival. The main results of this study were published, 1-3 and a long-term follow up is planned. In a second randomized study the effect of the combination of IFN-alpha and hydroxyurea versus hydroxyurea monotherapy on survival is being investigated. This paper provides a first preliminary report on the study concept, patient recruitment, state of documentation and initial patients' characteristics 9 months after closure of the study.
authors.affiliation: Klinikum Mannheim der Universität Heidelberg, Mannheim, Germany.
authors.forename: R
authors.initials: R
authors.lastname: Hehlmann
authors.forename: H
authors.initials: H
authors.lastname: Heimpel
authors.forename: D K
authors.initials: DK
authors.lastname: Hossfeld
authors.forename: J
authors.initials: J
authors.lastname: Hasford
authors.forename: H J
authors.initials: HJ
authors.lastname: Kolb
authors.forename: H
authors.initials: H
authors.lastname: Löffler
authors.forename: H
authors.initials: H
authors.lastname: Pralle
authors.forename: W
authors.initials: W
authors.lastname: Queisser
authors.forename: A
authors.initials: A
authors.lastname: Hochhaus
authors.forename: A
authors.initials: A
authors.lastname: Tichelli
authors.forename: W
authors.initials: W
authors.lastname: Fett
authors.forename: N
authors.initials: N
authors.lastname: Schmitz
authors.forename: A
authors.initials: A
authors.lastname: Reiter
authors.forename: M
authors.initials: M
authors.lastname: Griesshammer
authors.forename: W
authors.initials: W
authors.lastname: Pfeifer
authors.forename: M
authors.initials: M
authors.lastname: Bümler
authors.forename: T
authors.initials: T
authors.lastname: Kamp
authors.forename: A
authors.initials: A
authors.lastname: Tobler
authors.forename: H
authors.initials: H
authors.lastname: Eimermacher
authors.forename: R
authors.initials: R
authors.lastname: Kuse
authors.forename: U
authors.initials: U
authors.lastname: Berger
authors.forename: H
authors.initials: H
authors.lastname: Ansari
mesh_terms: D000328:Adult; D000970:Antineoplastic Agents / Q000008:administration & dosage*; D002985:Clinical Protocols; D003131:Combined Modality Therapy; D005260:Female; D005858:Germany; D006801:Humans; D006918:Hydroxyurea / Q000008:administration & dosage*; D016898:Interferon-alpha / Q000008:administration & dosage*; D015466:Leukemia, Myeloid, Chronic-Phase / Q000188:drug therapy* / Q000628:therapy*; D008297:Male; D008875:Middle Aged
chemical_list: D000970:Antineoplastic Agents; D016898:Interferon-alpha; D006918:Hydroxyurea