drugset / Trial / NCT01000285
EPOCH Chemotherapy and Bortezomib for Associated T-Cell Leukemia Lymphoma
NaSingle-groupOpen-labelTreatment
Summary
The rationale of the current study is to explore the use of combination chemotherapy together with antiretroviral agents in order to determine the efficacy and toxicity of this approach, while also examining markers of virus replication and expression, and tumor cell proliferation to gain understanding of the biological basis of this malignancy and to identify predictors of response.
Timeline
- Start
- 2010-09
- Primary completion
- 2014-05
- Completion
- 2016-04
Publications
- Background Ratner L, Harrington W, Feng X, Grant C, Jacobson S, Noy A, Sparano J, Lee J, Ambinder R, Campbell N, Lairmore M; AIDS Malignancy Consortium. Human T cell leukemia virus reactivation with progression of adult T-cell leukemia-lymphoma. PLoS One. 2009;4(2):e4420. doi: 10.1371/journal.pone.0004420. Epub 2009 Feb 10.
- Background Satou Y, Nosaka K, Koya Y, Yasunaga JI, Toyokuni S, Matsuoka M. Proteasome inhibitor, bortezomib, potently inhibits the growth of adult T-cell leukemia cells both in vivo and in vitro. Leukemia. 2004 Aug;18(8):1357-63. doi: 10.1038/sj.leu.2403400.
- Background Mitra-Kaushik S, Harding JC, Hess JL, Ratner L. Effects of the proteasome inhibitor PS-341 on tumor growth in HTLV-1 Tax transgenic mice and Tax tumor transplants. Blood. 2004 Aug 1;104(3):802-9. doi: 10.1182/blood-2003-11-3967. Epub 2004 Apr 15.
- Background Tsukasaki K, Hermine O, Bazarbachi A, Ratner L, Ramos JC, Harrington W Jr, O'Mahony D, Janik JE, Bittencourt AL, Taylor GP, Yamaguchi K, Utsunomiya A, Tobinai K, Watanabe T. Definition, prognostic factors, treatment, and response criteria of adult T-cell leukemia-lymphoma: a proposal from an international consensus meeting. J Clin Oncol. 2009 Jan 20;27(3):453-9. doi: 10.1200/JCO.2008.18.2428. Epub 2008 Dec 8.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bortezomib | Small molecule | 1 mg/m2 | Intravenous |
| Subject | Cyclophosphamide | Other / unclassified | 375 mg/m2 | Intravenous |
| Subject | Doxorubicin | Other / unclassified | 10 mg/m2 | Intravenous |
| Subject | Etoposide | Small molecule | 50 mg/m2 | Intravenous |
| Subject | Prednisone | Other / unclassified | 60 mg/m2 | Oral |
| Subject | Raltegravir | Other / unclassified | 400 mg | Oral |
| Subject | Vincristine | Small molecule | 0.4 mg/m2 | Intravenous |