Phase II trial of HyperCVAD and Dasatinib in patients with relapsed Philadelphia chromosome positive acute lymphoblastic leukemia or blast phase chronic myeloid leukemia

American Journal of Hematology

Volumn 89, Issue 3, 2014, Pages 282-287

  Benjamini, Ohad ^a   Dumlao, Theresa Liu ^a   Kantarjian, Hagop ^a   O'Brien, Susan ^a   Garcia Manero, Guillermo ^a   Faderl, Stefan ^a   Jorgensen, Jeffrey ^a   Luthra, Rajyalakshmi ^a   Garris, Rebecca ^a   Thomas, Deborah ^a   Kebriaei, Partow ^a   Champlin, Richard ^a   Jabbour, Elias ^a   Burger, Jan ^a   Cortes, Jorge ^a   Ravandi, Farhad ^a  

^a UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ABELSON KINASE; BREAKPOINT CLUSTER REGION PROTEIN; CYCLOPHOSPHAMIDE; CYTARABINE; DASATINIB; DEXAMETHASONE; DOXORUBICIN; IMATINIB; METHOTREXATE; PHOSPHOTRANSFERASE INHIBITOR; PREDNISONE; RITUXIMAB; VINCRISTINE;

ACUTE KIDNEY FAILURE; ACUTE LYMPHOBLASTIC LEUKEMIA; ADULT; AGED; ALLOGENEIC STEM CELL TRANSPLANTATION; ALLOTRANSPLANTATION; ARTICLE; CANCER COMBINATION CHEMOTHERAPY; CHRONIC MYELOID LEUKEMIA; CLINICAL ARTICLE; CYTOGENETICS; DISEASE COURSE; DONOR LYMPHOCYTE INFUSION; DRUG MEGADOSE; EPISTAXIS; FLOW CYTOMETRY; FOLLOW UP; GASTROINTESTINAL HEMORRHAGE; GENE MUTATION; HUMAN; HYPERBILIRUBINEMIA; HYPOCALCEMIA; HYPOKALEMIA; HYPOPHOSPHATEMIA; INDUCTION CHEMOTHERAPY; LEUKEMIA RELAPSE; LEUKOCYTE COUNT; LIVER FUNCTION TEST; LUNG HEMORRHAGE; MAINTENANCE THERAPY; MIDDLE AGED; MONOTHERAPY; NEUTROPENIA; OVERALL SURVIVAL; PERICARDIAL EFFUSION; PHASE 2 CLINICAL TRIAL; PHILADELPHIA CHROMOSOME POSITIVE CELL; PLEURA EFFUSION; PRIORITY JOURNAL; REMISSION; SIDE EFFECT; SUBDURAL HEMATOMA; TREATMENT DURATION; TREATMENT RESPONSE; YOUNG ADULT;

ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CYCLOPHOSPHAMIDE; DEXAMETHASONE; DOXORUBICIN; HUMANS; LEUKEMIA, MYELOGENOUS, CHRONIC, BCR-ABL POSITIVE; MIDDLE AGED; PHILADELPHIA CHROMOSOME; PRECURSOR CELL LYMPHOBLASTIC LEUKEMIA-LYMPHOMA; PYRIMIDINES; RECURRENCE; THIAZOLES; VINCRISTINE; YOUNG ADULT;

EID: 84896811150     PISSN: 03618609     EISSN: 10968652     Source Type: Journal    
DOI: 10.1002/ajh.23624     Document Type: Article

References (65)

1. Wetzler M, Dodge RK, Mrozek K, et al. Prospective karyotype analysis in adult acute lymphoblastic leukemia: The cancer and leukemia Group B experience. Blood 1999;93:3983-3993.
2. Faderl S, Jeha S, Kantarjian HM. The biology and therapy of adult acute lymphoblastic leukemia. Cancer 2003;98:1337-1354.
3. Burmeister T, Schwartz S, Bartram CR, et al. Patients' age and BCR-ABL frequency in adult B-precursor ALL: A retrospective analysis from the GMALL study group. Blood 2008;112:918-919.
4. Secker-Walker LM, Craig JM, Hawkins JM, et al. Philadelphia positive acute lymphoblastic leukemia in adults: Age distribution, BCR breakpoint and prognostic significance. Leukemia 1991;5:196-199.
5. Pui CH, Evans WE. Treatment of acute lymphoblastic leukemia. N Engl J Med 2006;354:166-178.
6. Gleissner B, Gokbuget N, Bartram CR, et al. 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 2002;99:1536-1543.
7. Vitale A, Guarini A, Chiaretti S, et al. The changing scene of adult acute lymphoblastic leukemia. Curr Opin Oncol 2006;18:652-659.
8. Bloomfield CD, Goldman AI, Alimena G, et al. Chromosomal abnormalities identify high-risk and low-risk patients with acute lymphoblastic leukemia. Blood 1986;67:415-420.
9. Gotz G, Weh HJ, Walter TA, et al. Clinical and prognostic significance of the Philadelphia chromosome in adult patients with acute lymphoblastic leukemia. Ann Hematol 1992;64:97-100.
10. Larson RA, Dodge RK, Burns CP, et al. A five-drug remission induction regimen with intensive consolidation for adults with acute lymphoblastic leukemia: Cancer and leukemia group B study 8811. Blood 1995;85:2025-2037.
11. Cytogenetic abnormalities in adult acute lymphoblastic leukemia: Correlations with hematologic findings outcome. A Collaborative Study of the Group Francais de Cytogenetique Hematologique. Blood 1996;87:3135-3142.
12. Secker-Walker LM, Prentice HG, Durrant J, et al. Cytogenetics adds independent prognostic information in adults with acute lymphoblastic leukaemia on MRC trial UKALL XA. MRC Adult Leukaemia Working Party. Br J Haematol 1997;96:601-610.
13. Faderl S, Kantarjian HM, Thomas DA, et al. Outcome of Philadelphia chromosome-positive adult acute lymphoblastic leukemia. Leuk Lymphoma 2000;36:263-273.
14. Dombret H, Gabert J, Boiron JM, et al. Outcome of treatment in adults with Philadelphia chromosome-positive acute lymphoblastic leukemia-Results of the prospective multicenter LALA-94 trial. Blood 2002;100:2357-2366.
15. Arico M, Valsecchi MG, Camitta B, et al. Outcome of treatment in children with Philadelphia chromosome-positive acute lymphoblastic leukemia. N Engl J Med 2000;342:998-1006.
16. Fielding AK. Current treatment of Philadelphia chromosome-positive acute lymphoblastic leukemia. Haematologica 2010;95:8-12.
17. Fielding AK, Rowe JM, Richards SM, et al. Prospective outcome data on 267 unselected adult patients with Philadelphia chromosome-positive acute lymphoblastic leukemia confirms superiority of allogeneic transplantation over chemotherapy in the pre-imatinib era: Results from the International ALL Trial MRC UKALLXII/ECOG2993. Blood 2009;113:4489-4496.
18. Delannoy A, Delabesse E, Lheritier V, et al. Imatinib and methylprednisolone alternated with chemotherapy improve the outcome of elderly patients with Philadelphia-positive acute lymphoblastic leukemia: Results of the GRAALL AFR09 study. Leukemia 2006;20:1526-1532.
19. 14th Congress of the European Hematology Association, Berlin, Germany, June 4-7, 2009. Haematologica 2009;94:1-694.
20. Yanada M, Takeuchi J, Sugiura I, et al. High complete remission rate and promising outcome by combination of imatinib and chemotherapy for newly diagnosed BCR-ABL-positive acute lymphoblastic leukemia: A phase II study by the Japan Adult Leukemia Study Group. J Clin Oncol 2006;24:460-466.
21. de Labarthe A, Rousselot P, Huguet-Rigal F, et al. Imatinib combined with induction or consolidation chemotherapy in patients with de novo Philadelphia chromosome-positive acute lymphoblastic leukemia: Results of the GRAAPH-2003 study. Blood 2007;109:1408-1413.
22. Ribera JM, Oriol A, Gonzalez M, et al. Concurrent intensive chemotherapy and imatinib before and after stem cell transplantation in newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia. Final results of the CSTIBES02 trial. Haematologica 2010;95:87-95.
23. Bassan R, Rossi G, Pogliani EM, et al. Chemotherapy-phased imatinib pulses improve long-term outcome of adult patients with Philadelphia chromosome-positive acute lymphoblastic leukemia: Northern Italy Leukemia Group protocol 09/00. J Clin Oncol 2010;28:3644-3652.
24. Wassmann B, Pfeifer H, Goekbuget N, et al. Alternating versus concurrent schedules of imatinib and chemotherapy as front-line therapy for Philadelphia-positive acute lymphoblastic leukemia (Ph+ ALL). Blood 2006;108:1469-1477.
25. Pfeifer H, Goekbuget N, Volp C, et al. Long-term outcome of 335 adult patients receiving different schedules of imatinib and chemotherapy as front-line treatment for Philadelphia-Positive Acute Lymphoblastic Leukemia (Ph+ ALL). ASH Annual Meeting Abstracts 2010;116:173.
26. Fielding AK, Buck G, Lazarus HM, et al. Imatinib significantly enhances long-term outcomes In Philadelphia Positive Acute Lymphoblastic Leukaemia; Final Results of the UKALLXII/ECOG2993 Trial. ASH Annual Meeting Abstracts 2010;116:169
27. Thomas DA, Faderl S, Cortes J, et al. Treatment of Philadelphia chromosome-positive acute lymphocytic leukemia with hyper-CVAD and imatinib mesylate. Blood 2004;103:4396-4407.
28. Thomas DA, O'Brien S, Faderl S, et al. Long-term outcome after hyper-CVAD and imatinib (IM) for de novo or minimally treated Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph-ALL). J Clin Oncol 2010;28(15_suppl): 6506.
29. Hughes T, Deininger M, Hochhaus A, et al. Monitoring CML patients responding to treatment with tyrosine kinase inhibitors: Review and recommendations for harmonizing current methodology for detecting BCR-ABL transcripts and kinase domain mutations and for expressing results. Blood 2006;108:28-37.
30. Pfeifer H, Wassmann B, Pavlova A, et al. Kinase domain mutations of BCR-ABL frequently precede imatinib-based therapy and give rise to relapse in patients with de novo Philadelphia-positive acute lymphoblastic leukemia (Ph+ ALL). Blood 2007;110:727-734.
31. Hu Y, Liu Y, Pelletier S, et al. Requirement of Src kinases Lyn, Hck and Fgr for BCR-ABL1-induced B-lymphoblastic leukemia but not chronic myeloid leukemia. Nat Genet 2004;36:453-461.
32. Hu Y, Swerdlow S, Duffy TM, et al. Targeting multiple kinase pathways in leukemic progenitors and stem cells is essential for improved treatment of Ph+ leukemia in mice. Proc Natl Acad Sci USA 2006;103:16870-16875.
33. Lombardo LJ, Lee FY, Chen P, et al. Discovery of N-(2-chloro-6-methyl- phenyl)-2-(6-(4-(2-hydroxyethyl)- piperazin-1-yl)-2-methylpyrimidin-4- ylamino)thiazole-5-carboxamide (BMS-354825), a dual Src/Abl kinase inhibitor with potent antitumor activity in preclinical assays. J Med Chem 2004;47:6658-6661.
34. O'Hare T, Walters DK, Stoffregen EP, et al. In vitro activity of Bcr-Abl inhibitors AMN107 and BMS-354825 against clinically relevant imatinib-resistant Abl kinase domain mutants. Cancer Res 2005;65:4500-4505.
35. Shah NP, Tran C, Lee FY, et al. Overriding imatinib resistance with a novel ABL kinase inhibitor. Science 2004;305:399-401.
36. Talpaz M, Shah NP, Kantarjian H, et al. Dasatinib in imatinib-resistant Philadelphia chromosome-positive leukemias. N Engl J Med 2006;354:2531-2541.
37. Ottmann O, Dombret H, Martinelli G, et al. Dasatinib induces rapid hematologic and cytogenetic responses in adult patients with Philadelphia chromosome positive acute lymphoblastic leukemia with resistance or intolerance to imatinib: interim results of a phase 2 study. Blood 2007;110:2309-2315.
38. Kantarjian H, Thomas D, O'Brien S, et al. Long-term follow-up results of hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone (Hyper-CVAD), a dose-intensive regimen, in adult acute lymphocytic leukemia. Cancer 2004;101:2788-2801.
39. Luthra R, Sanchez-Vega B, Medeiros LJ. TaqMan RT-PCR assay coupled with capillary electrophoresis for quantification and identification of bcr-abl transcript type. Mod Pathol 2004;17:96-103.
40. Jones D, Thomas D, Yin CC, et al. Kinase domain point mutations in Philadelphia chromosome-positive acute lymphoblastic leukemia emerge after therapy with BCR-ABL kinase inhibitors. Cancer 2008;113:985-994.
41. Luthra R, Medeiros LJ. Isothermal multiple displacement amplification: A highly reliable approach for generating unlimited high molecular weight genomic DNA from clinical specimens. J Mol Diagn 2004;6:236-242.
42. Weir EG, Cowan K, LeBeau P, et al. A limited antibody panel can distinguish B-precursor acute lymphoblastic leukemia from normal B precursors with four color flow cytometry: Implications for residual disease detection. Leukemia 1999;13:558-567.
43. Ottmann OG, Pfeifer H. Management of Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). ASH Education Program Book 2009;2009:371-381.
44. Schultz KR, Bowman WP, Aledo A, et al. Improved early event-free survival with imatinib in Philadelphia chromosome-positive acute lymphoblastic leukemia: A children's oncology group study. J Clin Oncol 2009;27:5175-5181.
45. Yanada M, Naoe T, Iida H, et al. Myeloablative allogeneic hematopoietic stem cell transplantation for Philadelphia chromosome-positive acute lymphoblastic leukemia in adults: Significant roles of total body irradiation and chronic graft-versus-host disease. Bone Marrow Transplant 2005;36:867-872.
46. Fielding AK, Richards SM, Chopra R, et al. Outcome of 609 adults after relapse of acute lymphoblastic leukemia (ALL); an MRC UKALL12/ECOG 2993 study. Blood 2007;109:944-950.
47. Ottmann OG, Druker BJ, Sawyers CL, et al. A phase 2 study of imatinib in patients with relapsed or refractory Philadelphia chromosome-positive acute lymphoid leukemias. Blood 2002;100:1965-1971.
48. Wassmann B, Pfeifer H, Scheuring U, et al. Therapy with imatinib mesylate (Glivec) preceding allogeneic stem cell transplantation (SCT) in relapsed or refractory Philadelphia-positive acute lymphoblastic leukemia (Ph+ALL). Leukemia 2002;16:2358-2365.
49. Druker BJ, Sawyers CL, Kantarjian H, et al. 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 2001;344:1038-1042.
50. Soverini S, De Benedittis C, Polakova KM, et al. Dissecting the complexity of Philadelphia-positive mutated populations by ultra-deep sequencing of the Bcr-Abl kinase domain: Biological and clinical implications. ASH Annual Meeting Abstracts 2012;120:692.
51. Muller MC, Cortes JE, Kim DW, et al. Dasatinib treatment of chronic-phase chronic myeloid leukemia: analysis of responses according to preexisting BCR-ABL mutations. Blood 2009;114:4944-4953.
52. Castillo E, Al-Rajabi R, Pandya DM, et al. A pilot study of the combination of Nilotinib and Hyper-CVAD for Philadelphia Chromosome Positive Acute Lymphocytic Leukemia and Lymphoid Blast Crisis Chronic Myelogenous Leukemia. ASH Annual Meeting Abstracts 2010;116:2144.
53. Porkka K, Martinelli G, Ottmann O, et al. Dasatinib efficacy in patients with imatinib-resistant/-intolerant Philadelphia-chromosome-positive acute lymphoblastic leukemia: 24-month data from START-L. Haematologica 2008;93.
54. Lilly MB, Ottmann OG, Shah NP, et al. Dasatinib 140 mg once daily versus 70 mg twice daily in patients with Ph-positive acute lymphoblastic leukemia who failed imatinib: Results from a phase 3 study. Am J Hematol 2010;85:164-170.
55. Foa R, Vitale A, Vignetti M, et al. Dasatinib as first-line treatment for adult patients with Philadelphia chromosome-positive acute lymphoblastic leukemia. Blood 2011;118:6521-6528.
56. Ravandi F, O'Brien S, Thomas D, et al. First report of phase 2 study of dasatinib with hyper-CVAD for the frontline treatment of patients with Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia. Blood 2010;116:2070-2077.
57. Boulos N, Mulder HL, Calabrese CR, et al. Chemotherapeutic agents circumvent emergence of dasatinib-resistant BCR-ABL kinase mutations in a precise mouse model of Philadelphia chromosome-positive acute lymphoblastic leukemia. Blood 2011;117:3585-3595.
58. Leis JF, Stepan DE, Curtin PT, et al. Central nervous system failure in patients with chronic myelogenous leukemia lymphoid blast crisis and Philadelphia chromosome positive acute lymphoblastic leukemia treated with imatinib (STI-571). Leuk Lymphoma 2004;45:695-698.
59. Pfeifer H, Wassmann B, Hofmann WK, et al. Risk and prognosis of central nervous system leukemia in patients with Philadelphia chromosome-positive acute leukemias treated with imatinib mesylate. Clin Cancer Res 2003;9:4674-4681.
60. Takayama N, Sato N, O'Brien SG, et al. Imatinib mesylate has limited activity against the central nervous system involvement of Philadelphia chromosome-positive acute lymphoblastic leukaemia due to poor penetration into cerebrospinal fluid. Br J Haematol 2002;119:106-108.
61. Porkka K, Koskenvesa P, Lundan T, et al. Dasatinib crosses the blood-brain barrier and is an efficient therapy for central nervous system Philadelphia chromosome-positive leukemia. Blood 2008;112:1005-1012.
62. Mortuza FY, Papaioannou M, Moreira IM, et al. Minimal residual disease tests provide an independent predictor of clinical outcome in adult acute lymphoblastic leukemia. J Clin Oncol 2002;20:1094-1104.
63. Ravandi F, Thomas DA, O'Brien S, et al. Detection of minimal residual leukemia predicts the outcome of patients with Philadelphia-chromosome positive acute lymphoblastic leukemia treated with tyrosine kinase inhibitors plus chemotherapy. ASH Annual Meeting Abstracts 2011;118:1453.
64. Lee S, Kim DW, Cho B, et al. Risk factors for adults with Philadelphia-chromosome-positive acute lymphoblastic leukaemia in remission treated with allogeneic bone marrow transplantation: the potential of real-time quantitative reverse-transcription polymerase chain reaction. Br J Haematol 2003;120:145-153.
65. Yanada M, Sugiura I, Takeuchi J, et al. Prospective monitoring of BCR-ABL1 transcript levels in patients with Philadelphia chromosome-positive acute lymphoblastic leukaemia undergoing imatinib-combined chemotherapy. Br J Haematol 2008;143:503-510.