Chronic myelogenous leukemia - historical

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The purpose of this page is to provide references to regimens that are obsolete, outdated, or of historical interest only. As a general rule, this includes the inferior arm(s) of a randomized study, unless said regimens continue to be recommended by trustworthy sources such as the NCCN Guidelines. Is there a regimen missing from this list? See the main CML page for current regimens.

5 regimens on this page
5 variants on this page


Chronic phase, first-line therapy

Hydroxyurea & Interferon alfa-2a

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Regimen

Study Years of enrollment Evidence Comparator Comparative Efficacy
Hehlmann et al. 2003 (CML-Study II) 1991-1994 Phase 3 (E-esc) Hydroxyurea Superior OS
Hehlmann et al. 2007 (CML-Study III) 1995-2001 Phase 3 (E-de-esc) Allo HSCT (no specific conditioning regimen) Seems to have superior OS
Gratwohl et al. 2015 (CML-Study IIIA) 1997-2004 Phase 3 (C) Allo HSCT (no specific conditioning regimen) Did not meet primary endpoint of OS

One of the few regimens compared in large RCTs against allogeneic HSCT.

Chemotherapy

Immunotherapy

References

  1. CML-Study II: Hehlmann R, Berger U, Pfirrmann M, Hochhaus A, Metzgeroth G, Maywald O, Hasford J, Reiter A, Hossfeld DK, Kolb HJ, Löffler H, Pralle H, Queisser W, Griesshammer M, Nerl C, Kuse R, Tobler A, Eimermacher H, Tichelli A, Aul C, Wilhelm M, Fischer JT, Perker M, Scheid C, Schenk M, Weiss J, Meier CR, Kremers S, Labedzki L, Schmeiser T, Lohrmann HP, Heimpel H; German CML Study Group. Randomized comparison of interferon alpha and hydroxyurea with hydroxyurea monotherapy in chronic myeloid leukemia (CML-study II): prolongation of survival by the combination of interferon alpha and hydroxyurea. Leukemia. 2003 Aug;17(8):1529-37. link to original article PubMed
  2. CML-Study III: Hehlmann R, Berger U, Pfirrmann M, Heimpel H, Hochhaus A, Hasford J, Kolb HJ, Lahaye T, Maywald O, Reiter A, Hossfeld DK, Huber C, Löffler H, Pralle H, Queisser W, Tobler A, Nerl C, Solenthaler M, Goebeler ME, Griesshammer M, Fischer T, Kremers S, Eimermacher H, Pfreundschuh M, Hirschmann WD, Lechner K, Wassmann B, Falge C, Kirchner HH, Gratwohl A. Drug treatment is superior to allografting as first-line therapy in chronic myeloid leukemia. Blood. 2007 Jun 1;109(11):4686-92. Epub 2007 Feb 22. link to original article does not contain protocol PubMed NCT00002771
  3. CML-Study IIIA: Gratwohl A, Pfirrmann M, Zander A, Kröger N, Beelen D, Novotny J, Nerl C, Scheid C, Spiekermann K, Mayer J, Sayer HG, Falge C, Bunjes D, Döhner H, Ganser A, Schmidt-Wolf I, Schwerdtfeger R, Baurmann H, Kuse R, Schmitz N, Wehmeier A, Fischer JT, Ho AD, Wilhelm M, Goebeler ME, Lindemann HW, Bormann M, Hertenstein B, Schlimok G, Baerlocher GM, Aul C, Pfreundschuh M, Fabian M, Staib P, Edinger M, Schatz M, Fauser A, Arnold R, Kindler T, Wulf G, Rosselet A, Hellmann A, Schäfer E, Prümmer O, Schenk M, Hasford J, Heimpel H, Hossfeld DK, Kolb HJ, Büsche G, Haferlach C, Schnittger S, Müller MC, Reiter A, Berger U, Saußele S, Hochhaus A, Hehlmann R; SAKK; German CML Study Group. Long-term outcome of patients with newly diagnosed chronic myeloid leukemia: a randomized comparison of stem cell transplantation with drug treatment. Leukemia. 2016 Mar;30(3):562-9. Epub 2015 Oct 14. link to original article does not contain protocol PubMed NCT00025402

Interferon alfa monotherapy

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Regimen

Study Years of enrollment Evidence Comparator Comparative Efficacy
Hehlmann et al. 1994 1983-1991 Phase 3 (E-switch-ooc) 1. Busulfan Superior OS
2. Hydrea Did not meet primary endpoint of OS

This article does not specify the exact type of interferon alfa.

Immunotherapy

Continued indefinitely

References

  1. Hehlmann R, Heimpel H, Hasford J, Kolb HJ, Pralle H, Hossfeld DK, Queisser W, Löffler H, Hochhaus A, Heinze B, Georgii A, Bartram CR, Griesshammer M, Bergmann L, Essers U, Falge C, Queisser U, Meyer P, Schmitz N, Eimermacher H, Walther F, Fett W, Kleeberg UR, Kabisch A, Nerl C, Zimmermann R, Meuret G, Tichelli A, Kanz L, Tigges FJ, Schmid L, Brockhaus W, Tobler A, Reiter A, Perker M, Emmerich B, Verpoort K, Zankovich R, Wussow PV, Prummer O, Thiele J, Buhr T, Carbonell F, Ansari H; German CML Study Group. Randomized comparison of interferon-alpha with busulfan and hydroxyurea in chronic myelogenous leukemia. Blood. 1994 Dec 15;84(12):4064-77. link to original article PubMed

Chronic phase, relapsed or refractory

Interferon alfa-2b & DLI

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DLI: Donor Lymphocyte Infusion

Regimen

Study Years of enrollment Evidence
Porter et al. 1994 NR Non-randomized, <20 pts

Patients had relapsed after allogeneic HSCT

Immunotherapy

References

  1. Porter DL, Roth MS, McGarigle C, Ferrara JL, Antin JH. Induction of graft-versus-host disease as immunotherapy for relapsed chronic myeloid leukemia. N Engl J Med. 1994 Jan 13;330(2):100-6. link to original article PubMed

Blast crisis

Hydroxyurea & Plicamycin

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Regimen

Study Years of enrollment Evidence
Koller & Miller 1986 NR Pilot, <20 pts (RT)

Chemotherapy

References

  1. Koller CA, Miller DM. Preliminary observations on the therapy of the myeloid blast phase of chronic granulocytic leukemia with plicamycin and hydroxyurea. N Engl J Med. 1986 Dec 4;315(23):1433-8. link to original article PubMed

Vincristine & Prednisone

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Regimen

Study Evidence
Marks et al. 1978 Non-randomized

Chemotherapy

Glucocorticoid therapy

References

  1. Marks SM, Baltimore D, McCaffrey R. Terminal transferase as a predictor of initial responsiveness to vincristine and prednisone in blastic chronic myelogenous leukemia: a co-operative study. N Engl J Med. 1978 Apr 13;298(15):812-4. link to original article PubMed