Conditions: Leukemia-Lymphoma, Adult T-Cell
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 18
Healthy volunteers: no

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.

Arms:
arm 1: Bortezomib 1.0 mg/m2 intravenous (IV) Days 1-4

Etoposide 50 mg/m2/d 96 hour continuous intravenous infusion (CIVI) on Days 1-4

Vincristine 0.4 mg/m2/d 96 hour CIVI on Days 1-4

Doxorubicin 10 mg/m2/d 96 hour CIVI on Days 1-4

Prednisone 60 mg/m2/d PO on Days 1-5

Cyclophosphamide 375 mg/m2 IV on Day 5

Raltegravir 400 mg PO twice per day (BID) every day starting with cycle 2 therapy for the entire duration of the cycle.

Cycles will be repeated every 21-28 days for 2 cycles beyond best response, or a maximum of 6 cycles.

Interventions: intervention 1: Bortezomib intervention 2: Etoposide intervention 3: Vincristine intervention 4: Doxorubicin intervention 5: Prednisone intervention 6: Cyclophosphamide intervention 7: Raltegravir
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None intervention 6: None intervention 7: None

Protocol document: