Spots Global Cancer Trial Database for EPOCH Chemotherapy and Bortezomib for Associated T-Cell Leukemia Lymphoma

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Trial Identification

Brief Title: EPOCH Chemotherapy and Bortezomib for Associated T-Cell Leukemia Lymphoma

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

Study ID: NCT01000285

Conditions

Leukemia-Lymphoma, Adult T-Cell

Interventions

Study Description

Brief 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.

Detailed Description: 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.