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EPOCH Chemotherapy and Bortezomib for Associated T-Cell Leukemia Lymphoma (ATLL)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01000285
First Posted: October 23, 2009
Last Update Posted: March 28, 2017
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.
Information provided by (Responsible Party):
Washington University School of Medicine
Results First Submitted: October 19, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Leukemia-Lymphoma, Adult T-Cell
Interventions: Drug: Bortezomib
Drug: Etoposide
Drug: Vincristine
Drug: Doxorubicin
Drug: Prednisone
Drug: Cyclophosphamide
Drug: Raltegravir

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study opened to participant enrollment on 12/22/2010 and closed to participant enrollment on 05/29/2014.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
EPOCH Chemotherapy & Bortezomib

Bortezomib 1.0 mg/m2 IV Days 1-4

Etoposide 50 mg/m2/d 96 hour 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 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.


Participant Flow:   Overall Study
    EPOCH Chemotherapy & Bortezomib
STARTED   18 
COMPLETED   18 
NOT COMPLETED   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Acute ATLL

Bortezomib 1.0 mg/m2 IV Days 1-4

Etoposide 50 mg/m2/d 96 hour 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 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.

Lymphoma ATLL

Bortezomib 1.0 mg/m2 IV Days 1-4

Etoposide 50 mg/m2/d 96 hour 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 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.

Total Total of all reporting groups

Baseline Measures
   Acute ATLL   Lymphoma ATLL   Total 
Overall Participants Analyzed 
[Units: Participants]
 6   12   18 
Age 
[Units: Years]
Median (Full Range)
 51.5 
 (38 to 70) 
 56 
 (36 to 76) 
 52 
 (36 to 76) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      4  66.7%      10  83.3%      14  77.8% 
Male      2  33.3%      2  16.7%      4  22.2% 
Region of Enrollment 
[Units: Participants]
     
United States   6   12   18 
Birthplace 
[Units: Participants]
     
Antigua   0   1   1 
Dominican Republic   1   0   1 
Haiti   0   3   3 
Jamaica   3   5   8 
USA   1   2   3 
Virgin Islands   0   1   1 
Bahamas   1   0   1 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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 ]

2.  Primary:   Efficacy of Treatment as Measured by Best Overall Response   [ Time Frame: Up to 4 years following completion of therapy ]

3.  Secondary:   Time to Progression   [ Time Frame: Up to 4 years following completion of therapy ]

4.  Secondary:   Effects of on HTLV-1 DNA After Treatment as Measured by Proviral Loads   [ Time Frame: 6 months ]

5.  Secondary:   Relation of NFκB Gene Expression Profile on Response   [ Time Frame: 6 months ]

6.  Secondary:   Effects of HTLV-1 RNA Load After Treatment as Measured by Hbz Messenger RNA   [ Time Frame: 6 months ]

7.  Secondary:   Effects of HTLV-1 Integrase Gene Sequence After Treatment as Measured by Nucleotide Divergence   [ Time Frame: 6 months ]

8.  Secondary:   Effects of HTLV-1 Integration Sites After Treatment   [ Time Frame: 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Lee Ratner, M.D., Ph.D.
Organization: Washington University School of Medicine
phone: 314-362-8836
e-mail: lratner@dom.wustl.edu


Publications:

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01000285     History of Changes
Other Study ID Numbers: 09-1758 / 201108212
First Submitted: October 19, 2009
First Posted: October 23, 2009
Results First Submitted: October 19, 2016
Results First Posted: December 13, 2016
Last Update Posted: March 28, 2017