Bone marrow transplantation
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Bone Marrow Transplant. · May 1996
Multicenter Study Comparative Study Clinical TrialComparative analysis of two consecutive phase II studies with IFN-alpha and IFN-alpha + ara-C in untreated chronic-phase CML patients. Austrian CML Study Group.
Two consecutive phase II studies with IFN-alpha (n = 55) and with IFN-alpha/ara-C (n = 84) are compared in a retrospective analysis of untreated chronic-phase CML patients. Hematological responses (CHR and PHR) were seen in 76% of patients after IFN-alpha and in 77% after IFN-alpha/ara-C treatment with a higher CHR rate in the latter group (45% versus 54%). Moreover, cytogenetic responses were observed more frequently in the IFN-alpha/ara-C study (44% versus 34%), including a higher rate of complete cytogenetic responses (13% versus 9%). The combined treatment modality induced higher rates of hematotoxicity (e.g. thrombocytopenia: 44% versus 25%) and gastrointestinal side effects (38% versus 15%) as compared to the monotherapy study.
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Bone Marrow Transplant. · May 1996
Randomized Controlled Trial Multicenter Study Comparative Study Clinical TrialLow-dose interferon-alpha 2b combined with hydroxyurea versus hydroxyurea alone for chronic myelogenous leukemia.
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Bone Marrow Transplant. · May 1996
Randomized Controlled Trial Multicenter Study Comparative Study Clinical TrialRandomized 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.
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. ⋯ 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.