Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2011 Apr 1;1(4):509-517.
doi: 10.4155/cli.11.24.

New considerations in the design of clinical trials for the treatment of acute leukemia

Christopher S Hourigan  1 , Judith E Karp
Affiliations

New considerations in the design of clinical trials for the treatment of acute leukemia

Christopher S Hourigan et al. Clin Investig (Lond). .

Abstract

There is great need for improved therapy for patients with acute leukemia. The current systems of clinical drug development and delivery of leukemia care are imperfectly adapted to the optimal identification and testing of future regimens. Novel clinical trial design with increased enrolment and appropriate end point selection would facilitate more efficient validation of candidate therapies. Clinical outcomes registries and biological sample storage would allow patient and leukemic factor substratification for the development of the next generation of targeted personalized therapy. We believe that the standard of care for patients in the USA diagnosed with acute leukemia, if treated with curative intent, is referral to a specialized center where an appropriate clinical trial can be offered.

Keywords: ALL; AML; acute lymphoblastic leukemia; acute myeloid leukemia; end point; leukemia; personalized therapy.

PubMed Disclaimer

Conflict of interest statement

Financial & competing interests disclosure

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties. No writing assistance was utilized in the production of this manuscript

Similar articles

See all similar articles

Cited by

References

Bibliography

    1. Horner MJ, Ries LAG, Krapcho M, et al. SEER Cancer Statistics Review, 1975–2006. Bethesda, MD: National Cancer Institute; 2009.

    1. Simone JV. History of the treatment of childhood ALL: a paradigm for cancer cure. Best Pract. Res. Clin. Haematol. 2006;19(2):353–359. ▪ An interesting eye-witness historical account of the development of effective therapy for childhood acute lymphoblastic leukemia (ALL)

    1. Aur RJ, Simone J, Hustu HO, et al. Central nervous system therapy and combination chemotherapy of childhood lymphocytic leukemia. Blood. 1971;37(3):272–281. - PubMed
    1. Vaughan WP, Karp JE. The long road to a cure for acute myelocytic leukemia: from intensity to specificity. J. Clin. Oncol. 2008;26(21):3475–3477. - PubMed
    1. Petrie K, Zelent A, Waxman S. Differentiation therapy of acute myeloid leukemia: past, present and future. Curr. Opin. Hematol. 2009;16(2):84–91. - PubMed

Websites

    1. US FDA. Pfizer voluntarily withdraws cancer treatment Mylotarg® from US market. [June 22nd 2010]; Press Release www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm216448.htm.
    1. President’s Cancer Panel 2004–2005 Annual Report. Translating research into cancer care: delivering on the promise. http://deainfo.nci.nih.gov/advisory/pcp/annualReports/pcp04–05rpt/Report....
    1. Christian MC. Delivering more innovative and effective treatments to make cancer a more treatable disease. 2004 May 13; Testimony to the Committee on Government Reform of the US House of Representatives www.hhs.gov/asl/testify/t040513b.html.
    1. NCCN Clinical Practice Guidelines in Oncology. [11 February 2010];Acute myeloid leukemia. Version 2.2011. Published www.nccn.org/professionals/physician_gls/PDF/aml.pdf.

LinkOut - more resources