Leukemia-Lymphoma, Adult T-Cell Clinical Trial
Official title:
Phase I/II Trial of Dose-Adjusted EPOCH Chemotherapy With Bortezomib Combined With Integrase Inhibitor Therapy for HTLV-1 Associated T-Cell Leukemia Lymphoma
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.
Primary Endpoint:
- To determine the tolerability and efficacy (response rate) of dose adjusted
bortezomib-EPOCH (DA B-EPOCH) chemotherapy combined with Raltegravir in patients with HTLV-1
associated leukemia/lymphoma (ATLL).
Secondary Endpoints:
- To evaluate the effects of DA B-EPOCH chemotherapy combined with Raltegravir on HTLV-1
DNA and RNA load, HTLV-1 integrase gene sequence, and HTLV-1 integration sites. To
determine if relapsed or progressive disease is a result of renewed virus replication.
- To evaluate the relation of NFκB gene expression profile on response to DA B-EPOCH
chemotherapy combined with Raltegravir.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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