Top

Published in:

01-11-2003 | Ongoing Clinical Studies

A randomized multicenter open label phase II study to determine the safety and efficacy of induction therapy with imatinib (Glivec, formerly STI571) in comparison with standard induction chemotherapy in elderly (>55 years) patients with Philadelphia chromosome-positive (Ph⁺/BCR-ABL⁺) acute lymphoblastic leukemia (ALL) (CSTI571ADE 10)

Authors: B. Wassmann, N. Gökbuget, U. J. Scheuring, A. Binckebanck, R. Reutzel, H. Gschaidmeier, D. Hoelzer, O. G. Ottmann, GMALL Study Group

Published in: Annals of Hematology | Issue 11/2003

Excerpt

Newly diagnosed Philadelphia chromosome-positive (Ph⁺)/BCR-ABL⁺ acute lymphoblastic leukemia (ALL) or chronic myeloid leukemia (CML) in lymphoid or bilineage blast crisis (BC) in patients older than 55 years (biological age). …

Gleißner B, Gökbuget N, Bartram CR, Janssen B, Rieder H, Janssen JW, Fonatsch C, Heyll A, Voliotis D, Beck J, Lipp T, Munzert G, Maurer J, Hoelzer D, Thiel E (2002) Leading prognostic relevance of the BCR-ABL translocation in adult acute B-lineage lymphoblastic leukemia: a prospective study of the German Multicenter Trial Group and confirmed polymerase chain reaction analysis. Blood 99:1536–1543CrossRefPubMed

Gökbuget N, Hoelzer D (2001) Acute lymphoblastic leukemia in adults. In: Henderson, Lister TA, Greaves MF (eds) Leukemia. W.B. Saunders, Philadelphia

Wassmann B, Pfeifer H, Scheuring UJ, Binckebanck A, Atta J, Brück P, Rieder H, Schoch C, Leimer L, Schwerdtfeger R, Ehninger G, Lipp T, Perz J, Stelljes M, Gschaidmeier H, Hoelzer D, Ottmann OG (2002) Imatinib mesylate (Glivec, STI571) in patients with relapsed or refractory Philadelphia Chromosome positive acute lymphoblastic leukemia (Ph+ALL): extended follow-up and analysis of prognostic factors. Blood 100:87a

Gökbuget N, Hoelzer D, Arnold R (2000) Treatment of adult ALL according to the protocols of the German Multicenter Study Group for Adult ALL (GMALL). Hematol Oncol Clin North Am 14:1307–1325PubMed

Hussein KK, Dahlberg S, Head D, Waddell CC, Dabich L, Weick JK, Morrison F, Saiki JH, Metz E, Rivkin SE (1989) Treatment of acute lymphoblastic leukemia in adults with intensive induction, consolidation, and maintenance chemotherapy. Blood 73:57–63PubMed

Thomas X, Olteanu N, Charrin C, Lheritier V, Magaud JP, Fiere D (2001) Acute lymphoblastic leukemia in the elderly: the Edouard Herriot Hospital experience. Am J Hematol 67:73–83CrossRefPubMed

Kantarjian HM, O'Brien S, Smith TL (2000) Results of treatment with hyper-CVAD, a dose-intensive regimen, in adult acute lymphocytic leukemia. J Clin Oncol 18:547–561PubMed

Thomas X, Thiebaut A, Olteanu N, Danaila C, Charrin C, Archimbaud E, Fiere D (1998) Philadelphia chromosome positive adult acute lymphoblastic leukemia: characteristics, prognostic factors and treatment outcome. Hematol Cell Ther 40:119–128PubMed

Gökbuget N, de Wit M, Gerhardt A, Lipp T, Schwartz S, Sommer S, Voliotis D, Thiel E, Hoelzer D (2000) Results of a shortened, dose reduced treatment protocol in elderly patients with acute lymphoblastic leukemia. Blood 96 [Suppl 1]:3104a

10.

Cornelissen JJ, Carston M, Kollman C, King R, Dekker AW, Lowenberg B, Anasetti C (2001) Unrelated marrow transplantation for adult patients with poor-risk acute lymphoblastic leukemia: strong graft-versus-leukemia effect and risk factors determining outcome. Blood 97:1572–1577CrossRefPubMed

11.

Dunlop LC, Powles R, Singhal S, Treleaven JG, Swansbury GJ, Meller S, Pinkerton CR, Horton C, Mehta J (1996) Bone marrow transplantation for Philadelphia chromosome-positive acute lymphoblastic leukemia. Bone Marrow Transplant 17:365–369PubMed

12.

Snyder DS, Nademanee AP, O'Donnell MR, Parker PM, Stein AS, Margolin K, Somlo G, Molina A, Spielberger R, Kashyap A, Fung H, Slovak ML, Dagis A, Negrin RS, Amylon MD, Blume KG, Forman SJ (1999) Long-term follow-up of 23 patients with Philadelphia chromosome-positive acute lymphoblastic leukemia treated with allogeneic bone marrow transplant in first complete remission. Leukemia 13:2053–2058CrossRefPubMed

13.

Martin TG, Gajewski JL (2001) Allogeneic stem cell transplantation for acute lymphocytic leukemia in adults. Hematol Oncol Clin North Am 15:97–120PubMed

14.

Druker BJ, Sawyers CL, Kantarjian H, Resta DJ, Reese SF, Ford JM, Capdeville R, Talpaz M (2001) Activity of a specific inhibitor of the BCR-ABL tyrosine kinase in the blast crisis of chronic myeloid leukemia and acute lymphoblastic leukemia with the Philadelphia chromosome. N Engl J Med 344:1038–1042PubMed

15.

Ottmann OG, Druker BJ, Sawyers CL, Goldman JM, Reiffers J, Silver RT, Tura S, Fischer T, Deininger MW, Schiffer CA, Baccarani M, Gratwohl A, Hochhaus A, Hoelzer D, Fernandes-Reese S, Gathmann I, Capdeville R, O'Brien SG (2002) A phase 2 study of imatinib in patients with relapsed or refractory Philadelphia chromosome-positive acute lymphoid leukemias. Blood 100:1965–1971CrossRefPubMed

16.

Garcia-Manero G, Thomas DA (2001) Salvage therapy for refractory or relapsed acute lymphocytic leukemia. Hematol Oncol Clin North Am 15:163–205PubMed

17.

Hofmann WK, Jones LC, Lemp NA, de Vos S, Gschaidmeier H, Hoelzer D, Ottmann OG, Koeffler HP (2002) Ph(+) acute lymphoblastic leukemia resistant to the tyrosine kinase inhibitor STI571 has a unique BCR-ABL gene mutation. Blood 99:1860–1862CrossRefPubMed

18.

von Bubnoff N, Schneller F, Peschel C, Duyster J (2002) BCR-ABL gene mutations in relation to clinical resistance of Philadelphia-chromosome-positive leukaemia to STI571: a prospective study. Lancet 359:487–491CrossRefPubMed

19.

Wassmann B, Pfeifer H, Scheuring U, Binckebanck A, Gökbuget N, Atta J, Brück P, Rieder H, Schoch C, Leimer L, Schwerdtfeger R, Ehninger G, Lipp T, Ho AD, Stelljes M, Gschaidmeier H, Hoelzer D, Ottmann OG (2003) Early prediction of response in patients with relapsed or refractory Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ALL) treated with imatinib mesylate (Glivec) (submitted)

20.

Scheuring UJ, Pfeifer H, Wassmann B, Brück P, Atta J, Petershofen E, Gehrke B, Gschaidmeier H, Hoelzer D, Ottmann OG (2003) Early minimal residual disease (MRD) analysis during treatment of Philadelphia chromosome / Bcr-Abl positive acute lymphoblastic leukemia (Ph+ALL with the ABL-tyrosine kinase inhibitor STI571 (Glivec). Blood 101:85–90CrossRefPubMed

21.

Ottmann OG, Wassmann B, Scheuring UJ, Pfeifer H, Brück P, Goekbuget N, Binckebanck A, Gehrke B, Gschaidmeier H, Hoelzer D (2002) Minimal residual disease (MRD)-triggered imatinib mesylate (Glivec, STI571) in first-line treatment of Philadelphia chromosome (Ph+) acute lymphoid leukemias: reduction of MRD levels but no induction of molecular remissions. Blood 100:85aCrossRef

22.

Kano Y, Akutsu M, Tsunoda S, Mano H, Sato Y, Honma Y, Furukawa Y (2001) In vitro cytotoxic effects of a tyrosine kinase inhibitor STI571 in combination with commonly used antileukemic agents. Blood 97:1999–2007PubMed

23.

Thiesing JT, Ohno-Jones S, Kolibaba KS, Druker BJ (2000) Efficacy of STI571, an abl tyrosine kinase inhibitor, in conjunction with other antileukemic agents against bcr-abl-positive cells. Blood 96:3195–3199PubMed

24.

Thomas DA, Cortes J, Giles FJ, Faderl S, O'Brien S, Rios MB, Issa JP, Garcia-Manero G, Koller C, Capdeville R, Talpaz M, Kantarjian H (2001) Combination of hyper-CVAD with imatinib mesylate (STI571) for Philadelphia (Ph)-positive adult acute lymphoblastic leukemia (ALL) or chronic myelogenous leukemia in lymphoid blast phase (CML-LBP). Blood 98:802a

25.

Leis JF, Stepan DE, Curtin PT, Peng B, Ford JM, Schubach SE, Fleming WH, Druker BJ, Maziarz RT (2001) Low penetration of imatinib (STI571) into the CSF indicates the need for standard CNS prophylaxis in patients with CML lymphoid blast crisis and Philadelphia chromosome positive ALL. Blood 98:140a

26.

Petzer AL, Gunsilius E, Hayes M, Stockhammer G, Duba HC, Schneller F, Grunewald K, Poewe W, Gastl G (2002) Low concentrations of STI571 in the cerebrospinal fluid: a case report. Br J Haematol 117:623–625CrossRefPubMed

27.

Takayama N, Sato N, O'Brien SG, Ikeda Y, Okamoto S (2002) Imatinib mesylate has limited activity against the central nervous system involvement of Philadelphia chromosome-positive acute lymphoblastic leukemia due to poor penetration into cerebrospinal fluid. Br J Haematol 119:106–108CrossRefPubMed

Title: A randomized multicenter open label phase II study to determine the safety and efficacy of induction therapy with imatinib (Glivec, formerly STI571) in comparison with standard induction chemotherapy in elderly (>55 years) patients with Philadelphia chromosome-positive (Ph+/BCR-ABL+) acute lymphoblastic leukemia (ALL) (CSTI571ADE 10)
Authors: B. Wassmann
N. Gökbuget
U. J. Scheuring
A. Binckebanck
R. Reutzel
H. Gschaidmeier
D. Hoelzer
O. G. Ottmann
GMALL Study Group
Publication date: 01-11-2003
Publisher: Springer-Verlag
Published in: Annals of Hematology / Issue 11/2003
Print ISSN: 0939-5555
Electronic ISSN: 1432-0584
DOI: https://doi.org/10.1007/s00277-003-0728-8

ACC 2024 Congress Coverage

Heart Failure Video

Keynote webinar | Spotlight on sleep in brain health

Springer Medicine

Excerpt

ACC 2024 Congress Coverage

Year in Review: Heart failure and cardiomyopathies

Semaglutide benefits people with type 2 diabetes and obesity-related heart failure

Incentivised to exercise

New intervention for STEMI-related cardiogenic shock

» View more highlights on the ACC 2024 congress hub page

Keynote webinar | Spotlight on sleep in brain health

Springer Medicine

Excerpt

Please log in to get access to this content

Other articles of this Issue 11/2003

Severe factor X deficiency treated with heparin-added prothrombin complex concentrate

Thrombopoietin stimulates ex vivo expansion of mature neutrophils in the early stages of differentiation

November 2003

Life-threatening thrombotic thrombocytopenic purpura (TTP) in a patient with sickle cell-hemoglobin C disease

Prior and concurrent administration of recombinant human megakaryocyte growth and development factor in patients receiving consolidation chemotherapy for de novo acute myeloid leukemia—a randomized, placebo-controlled, double-blind safety and efficacy study

Non-Hodgkin's lymphoma in the elderly

ACC 2024 Congress Coverage

Year in Review: Heart failure and cardiomyopathies

Semaglutide benefits people with type 2 diabetes and obesity-related heart failure

Incentivised to exercise

New intervention for STEMI-related cardiogenic shock

» View more highlights on the ACC 2024 congress hub page