Current Clinical Trials

Note: Some citations in the text of this section are followed by a level of evidence. The PDQ editorial boards use a formal ranking system to help the reader judge the strength of evidence linked to the reported results of a therapeutic strategy. (Refer to the PDQ summary on Levels of Evidence for more information.)

Standard treatment options:

1. Imatinib mesylate has demonstrated marked activity in patients with myeloid blast crisis and in patients with lymphoid blast crisis or Philadelphia chromosome-positive acute lymphoblastic leukemia. In a phase I trial, 4 of 38 patients with myeloid blast crisis had a complete hematologic remission, and 17 patients had a decrease in blasts in the marrow to 15% or less.[1] Of the 20 patients in the lymphoid cohort, 4 patients had a complete hematologic response, and 10 patients had a decrease in blasts in the marrow to 15% or less. These kinds of responses have not been durable. Of 21 responding patients with myeloid blast crisis, 9 relapsed between 42 and 194 days; of the 14 responding patients with lymphoid disease, 12 relapsed with a median duration of time to relapse of 58 days. Seven of the 21 responding patients with myeloid blast crisis continue in remission with longest follow-up of 349 days. These response data are the highest single agent responses in this disease.[1]

   Two larger trials involving a total of 304 patients in blastic-phase chronic myelogenous leukemia (CML) confirm a hematologic response rate of 52% to 55% and a major cytogenetic response rate of 16%, but the estimated 1-year survival is under 35%.[2,3][Level of evidence: 3iiiA] Clinical trials will explore combining imatinib mesylate with other drugs to improve the prognosis of patients with blastic-phase CML.[4]

2. Vincristine and prednisone with or without an anthracycline (for the approximately 25% of patients with terminal deoxynucleotidyl transferase-positive cells and lymphoblastic transformation).[5,6]
3. Allogeneic bone marrow transplantation (BMT) is successful in less than 10% of patients because of complications of transplantation and recurrent leukemia.[7] If available, this represents the only potentially curative approach in such patients. Allogeneic BMT is more effective in patients induced into a second chronic phase, with long-term disease-free survival approximating 20%.[8]
4. Hydroxyurea as palliative therapy.
5. High-dose cytarabine.[9]

Check for U.S. clinical trials from NCI's PDQ Cancer Clinical Trials Registry that are now accepting patients with blastic phase chronic myelogenous leukemia. The list of clinical trials can be further narrowed by location, drug, intervention, and other criteria.

General information about clinical trials is also available from the NCI Web site.

References

1. 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 344 (14): 1038-42, 2001.  [PUBMED Abstract]
   
   
2. Kantarjian HM, Cortes J, O'Brien S, et al.: Imatinib mesylate (STI571) therapy for Philadelphia chromosome-positive chronic myelogenous leukemia in blast phase. Blood 99 (10): 3547-53, 2002.  [PUBMED Abstract]
   
   
3. Sawyers CL, Hochhaus A, Feldman E, et al.: Imatinib induces hematologic and cytogenetic responses in patients with chronic myelogenous leukemia in myeloid blast crisis: results of a phase II study. Blood 99 (10): 3530-9, 2002.  [PUBMED Abstract]
   
   
4. Fruehauf S, Topaly J, Buss EC, et al.: Imatinib combined with mitoxantrone/etoposide and cytarabine is an effective induction therapy for patients with chronic myeloid leukemia in myeloid blast crisis. Cancer 109 (8): 1543-9, 2007.  [PUBMED Abstract]
   
   
5. Preti HA, O'Brien S, Giralt S, et al.: Philadelphia-chromosome-positive adult acute lymphocytic leukemia: characteristics, treatment results, and prognosis in 41 patients. Am J Med 97 (1): 60-5, 1994.  [PUBMED Abstract]
   
   
6. Walters RS, Kantarjian HM, Keating MJ, et al.: Therapy of lymphoid and undifferentiated chronic myelogenous leukemia in blast crisis with continuous vincristine and adriamycin infusions plus high-dose decadron. Cancer 60 (8): 1708-12, 1987.  [PUBMED Abstract]
   
   
7. Copelan EA, Grever MR, Kapoor N, et al.: Marrow transplantation following busulfan and cyclophosphamide for chronic myelogenous leukaemia in accelerated or blastic phase. Br J Haematol 71 (4): 487-91, 1989.  [PUBMED Abstract]
   
   
8. Gratwohl A, Hermans J, Niederwieser D, et al.: Bone marrow transplantation for chronic myeloid leukemia: long-term results. Chronic Leukemia Working Party of the European Group for Bone Marrow Transplantation. Bone Marrow Transplant 12 (5): 509-16, 1993.  [PUBMED Abstract]
   
   
9. Kantarjian HM, Talpaz M, Kontoyiannis D, et al.: Treatment of chronic myelogenous leukemia in accelerated and blastic phases with daunorubicin, high-dose cytarabine, and granulocyte-macrophage colony-stimulating factor. J Clin Oncol 10 (3): 398-405, 1992.  [PUBMED Abstract]
   
   

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