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, Volume 56, Issue 2, pp 87–91 | Cite as

Randomized study on the treatment of chronic myeloid leukemia (CML) in chronic phase with busulfan versus hydroxyurea versus interferon-alpha

  • R. Hehlmann
  • B. Anger
  • D. Messerer
  • R. Zankovich
  • L. Bergmann
  • H. J. Kolb
  • P. Meyer
  • U. Essers
  • U. Queißer
  • H. Vaupel
  • F. Walther
  • D. K. Hossfeld
  • R. Zimmermann
  • F. Heiss
  • S. Mende
  • F. J. Tigges
  • U. R. Kleeberg
  • H. Pralle
  • W. Kayser
  • A. Tichelli
  • J. D. Faulhaber
  • U. Räth
  • H. Schubert
  • K. Bross
  • R. Schlag
  • L. Schmid
  • I. Weißenfels
  • B. Heinze
  • A. Georgii
  • W. Queißer
  • H. Heimpel
Ongoing Clinical Trial

Summary

For palliative therapy during the chronic phase of CML busulfan has proved to be the drug of choice. During the past years hydroxyurea and also interferon-alpha have gained increasing significance since they might prolong the duration of the chronic phase. In a multicenter study it is being determined, whether the use of hydroxyurea or of interferon-alpha instead of busulfan prolongs the duration of the chronic phase of Philadelphia positive CML. Additional goals are the examination of whether the types of disease evolution and the terminal phases differ between the treatment groups, and the prospective recognition of prognostic criteria for the duration of the chronic phase of CML. By December 31, 1987, 326 CML-patients had been randomized, 150 for busulfan, 150 for hydroxyurea and 26 for interferon-alpha. The average age is 50 years. 59 patients reached the end of the chronic phase, 55 died. The mean observation time of all patients is 1.34 years. At present no significant difference in survival is recognizable between the busulfan and hydroxyurea groups. Fewer adverse effects have been observed in the hydroxyurea group. Philadelphia chromosome negative patients show a higher average age and tend to have lower white blood cell and platelet counts. The number of patients having received interferon-alpha is still too small to allow evaluation. This report intends to document organization and progress of this study which to our knowledge is, at present, the largest ongoing prospective multicenter study on the therapy of CML.

Key words

CML Busulfan Hydroxyurea Interferon-alpha Duration of chronic phase Prospective study 

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Copyright information

© Springer-Verlag 1988

Authors and Affiliations

  • R. Hehlmann
    • 1
  • B. Anger
    • 2
  • D. Messerer
    • 3
  • R. Zankovich
    • 4
  • L. Bergmann
    • 5
  • H. J. Kolb
    • 6
  • P. Meyer
    • 7
  • U. Essers
    • 8
  • U. Queißer
    • 9
  • H. Vaupel
    • 10
  • F. Walther
    • 11
  • D. K. Hossfeld
    • 12
  • R. Zimmermann
    • 13
    • 20
  • F. Heiss
    • 14
  • S. Mende
    • 15
  • F. J. Tigges
    • 16
  • U. R. Kleeberg
    • 17
  • H. Pralle
    • 18
  • W. Kayser
    • 19
  • A. Tichelli
    • 21
  • J. D. Faulhaber
    • 22
  • U. Räth
    • 23
  • H. Schubert
    • 24
  • K. Bross
    • 25
  • R. Schlag
    • 26
  • L. Schmid
    • 27
  • I. Weißenfels
    • 28
  • B. Heinze
    • 29
  • A. Georgii
    • 30
  • W. Queißer
    • 9
  • H. Heimpel
    • 2
  1. 1.Medizinische Poliklinik der Universität MünchenMünchen 2Federal Republic of Germany
  2. 2.Zentrum Innere Medizin UlmUlmFederal Republic of Germany
  3. 3.Biometrisches Zentrum für TherapiestudienMünchen 2Federal Republic of Germany
  4. 4.I. Medizinische Klinik der Universität KölnKöln 41Federal Republic of Germany
  5. 5.Abteilung für Hämatologie und OnkologieZentrum der Inneren Medizin Frankfurt/MainFrankfurt/MainFederal Republic of Germany
  6. 6.3. Medizinische Klinik, Klinikum München-GroßhadernMünchen 70Federal Republic of Germany
  7. 7.Medizinische Poliklinik der UniversitätWürzburgFederal Republic of Germany
  8. 8.Hämatologisch-onkologische Praxis AachenAachenFederal Republic of Germany
  9. 9.Onkologisches Zentrum, Klinikum der Stadt MannheimMannheimFederal Republic of Germany
  10. 10.Medizinische Klinik II, St.-Johannes-HospitalDuisburgFederal Republic of Germany
  11. 11.Onkologische GemeinschaftspraxisFrankfurt/MainFederal Republic of Germany
  12. 12.Medizinische Universitäts-KlinikHamburg-Eppendorf 20Federal Republic of Germany
  13. 13.Abteilung Innere Medizin und PoliklinikUniversitätsklinikum Berlin-CharlottenburgBerlin 19Germany
  14. 14.I. Medizinische AbteilungStädtisches KrankenhausMünchen-Schwabing 40Federal Republic of Germany
  15. 15.Medizinische Klinik, St.-Elisabethen-KrankenhausRavensburgFederal Republic of Germany
  16. 16.Münchner Onkologische Praxis, PrielmayerstrasseMünchen 2Federal Republic of Germany
  17. 17.Hämatologisch-onkologische Praxis AltonaHamburg 50Federal Republic of Germany
  18. 18.Medizinische Klinik IV mit Hämatologie und OnkologieGiessenFederal Republic of Germany
  19. 19.Medizinische Klinik IIUniversität KielKielFederal Republic of Germany
  20. 20.Stadtkrankenhaus KemptenKemptenFederal Republic of Germany
  21. 21.Abteilung für OnkologieKantonsspital BaselBaselSwitzerland
  22. 22.Kreiskrankenhaus AalenAalenFederal Republic of Germany
  23. 23.Medizinische UniversitätsklinikHeidelbergFederal Republic of Germany
  24. 24.Medizinische Klinik, St.-Joseph-HospitalBremerhavenFederal Republic of Germany
  25. 25.Medizinische Universitäts-KlinikFreiburg i. Br.Federal Republic of Germany
  26. 26.Medizinische Klinik Innenstadt, ZiemssenstrasseMünchen 2Federal Republic of Germany
  27. 27.Kantonsspital St. GallenSt. GallenSwitzerland
  28. 28.Onkologisch-hämatologische SchwerpunktpraxisBerlin 21Germany
  29. 29.Abteilung für Klinische Physiologie und Arbeitsmedizin der Universität UlmUlmFederal Republic of Germany
  30. 30.Pathologisches Institut der MHH HannoverHannoverFederal Republic of Germany

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