NCT01000285

EPOCH Chemotherapy and Bortezomib for Associated T-Cell Leukemia Lymphoma

Phase I/II Trial of Dose-Adjusted EPOCH Chemotherapy With Bortezomib Combined With Integrase Inhibitor Therapy for HTLV-1 Associated T-Cell Leukemia Lymphoma

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Leukemia-Lymphoma, Adult T-Cell

Interventions

Type	Name	Description
DRUG	Bortezomib
DRUG	Etoposide
DRUG	Vincristine
DRUG	Doxorubicin
DRUG	Prednisone
DRUG	Cyclophosphamide
DRUG	Raltegravir

Timeline

• Start date: 2010-09-01
• Primary completion: 2014-05-01
• Completion: 2016-04-01
• First posted: 2009-10-23
• Last updated: 2017-03-28
• Results posted: 2016-12-13

Locations

6 sites across 1 country: United States