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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
University of Miami Hospital/Sylvester
Miami, Florida, United States
Johns Hopkins University
Baltimore, Maryland, United States
Washington University School of Medicine
St Louis, Missouri, United States
Columbia University, College of Physicians and Surgeons
New York, New York, United States
Tolerability of Treatment as Measured by Number of Participants With Grade 3 or Higher Adverse Events
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for all toxicity reporting.
Time frame: Up to 30 days after completion of treatment
Efficacy of Treatment as Measured by Best Overall Response
-The response definitions used for this study are the 2007 Cheson criteria.
Time frame: Up to 4 years following completion of therapy
Time to Progression
-The progression definitions used for this study are from the 2007 Cheson criteria.
Time frame: Up to 4 years following completion of therapy
Effects of on HTLV-1 DNA After Treatment as Measured by Proviral Loads
Time frame: 6 months
Relation of NFκB Gene Expression Profile on Response
Standard error represents the standard error of the fold expression of protein coding transcripts for each gene indicated.
Time frame: 6 months
Effects of HTLV-1 RNA Load After Treatment as Measured by Hbz Messenger RNA
Time frame: 6 months
Effects of HTLV-1 Integrase Gene Sequence After Treatment as Measured by Nucleotide Divergence
Time frame: 6 months
Effects of HTLV-1 Integration Sites After Treatment
Time frame: 6 months
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Memorial Sloan Kettering Cancer Center
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States