EPOCH Chemotherapy and Bortezomib for Associated T-Cell Leukemia Lymphoma (ATLL)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01000285|
Recruitment Status : Completed
First Posted : October 23, 2009
Results First Posted : December 13, 2016
Last Update Posted : March 28, 2017
|Condition or disease||Intervention/treatment||Phase|
|Leukemia-Lymphoma, Adult T-Cell||Drug: Bortezomib Drug: Etoposide Drug: Vincristine Drug: Doxorubicin Drug: Prednisone Drug: Cyclophosphamide Drug: Raltegravir||Phase 1 Phase 2|
- 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).
- 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 (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||September 2010|
|Actual Primary Completion Date :||May 2014|
|Actual Study Completion Date :||April 2016|
Experimental: 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.
Other Name: Velcade®Drug: Etoposide
Other Name: Toposar®, VePesid®, Etopophos®Drug: Vincristine
Other Name: Oncovin ®, Vincasar Pfs ®Drug: Doxorubicin
Other Name: Adriamycin ®, Rubex ®Drug: Prednisone
Other Name: Deltasone®, Liquid Pred®, Meticorten®, Orasone®Drug: Cyclophosphamide
Other Name: Cytoxan ®, Neosar ®Drug: Raltegravir
Other Name: Isentress®
- Tolerability of Treatment as Measured by Number of Participants With Grade 3 or Higher Adverse Events [ Time Frame: Up to 30 days after completion of treatment ]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.
- Efficacy of Treatment as Measured by Best Overall Response [ Time Frame: Up to 4 years following completion of therapy ]-The response definitions used for this study are the 2007 Cheson criteria.
- Time to Progression [ Time Frame: Up to 4 years following completion of therapy ]-The progression definitions used for this study are from the 2007 Cheson criteria.
- 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 [ Time Frame: 6 months ]Standard error represents the standard error of the fold expression of protein coding transcripts for each gene indicated.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01000285
|United States, Florida|
|University of Miami Hospital/Sylvester|
|Miami, Florida, United States, 33136|
|United States, Maryland|
|Johns Hopkins University|
|Baltimore, Maryland, United States, 21231|
|United States, Missouri|
|Washington University School of Medicine|
|St. Louis, Missouri, United States, 63110|
|United States, New York|
|Montefiore Medical Center|
|Bronx, New York, United States, 10467|
|Columbia University, College of Physicians and Surgeons|
|New York, New York, United States, 10032|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Lee Ratner, M.D., Ph.D.||Washington University School of Medicine|