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Standard of Care vs. Bortezomib in Graft-Versus Host Disease After Hematopoietic Stem Cell Transplant

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01754389
First Posted: December 21, 2012
Last Update Posted: July 18, 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):
John Koreth, MD, Dana-Farber Cancer Institute
Results First Submitted: May 22, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Graft Versus Host Disease
Interventions: Drug: Tacrolimus
Drug: Methotrexate
Drug: Bortezomib
Drug: Sirolimus

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

Excluded (n= 4)

  • Not meeting inclusion criteria (n=3;active infection (2*), disease relapse (2*))
  • Declined to participate (n=1; interacting medication per provider preference (1))

Reporting Groups
  Description
Arm A (Standard of Care)

Drug: Tacrolimus, Methotrexate

Tacrolimus intravenously and orally, Day -3 through 3-6 months post-transplant Methotrexate intravenously on days 1, 3, 6 and 11 post-transplant

Arm B (Experimental)

Drug: Bortezomib, Tacrolimus, Methotrexate Other Names: Velcade

Bortezomib intravenously 1, 4 and 7 days post-transplant Tacrolimus intravenously and orally, Day -3 through 3-6 months post-transplant Methotrexate intravenously 1,3,6 and 11 days post-transplant

Arm C (Experimental)

Drug: Bortezomib, Sirolimus, Tacrolimus Other Names: Velcade

Bortezomib intravenously 1,4 and 7 days post-transplant Sirolimus, intravenously and orally, Day -3 through 3-6 months post-transplant Tacrolimus, intravenously and orally, Day -3 through 3-6 months post-transplant


Participant Flow:   Overall Study
    Arm A (Standard of Care)   Arm B (Experimental)   Arm C (Experimental)
STARTED   46   45   47 
COMPLETED   46   45   47 
NOT COMPLETED   0   0   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
Arm A (Standard of Care)

Drug: Tacrolimus, Methotrexate

Tacrolimus intravenously and orally, Day -3 through 3-6 months post-transplant Methotrexate intravenously on days 1, 3, 6 and 11 post-transplant

Arm B (Experimental)

Drug: Bortezomib, Tacrolimus, Methotrexate Other Names: Velcade

Bortezomib intravenously 1, 4 and 7 days post-transplant Tacrolimus intravenously and orally, Day -3 through 3-6 months post-transplant Methotrexate intravenously 1,3,6 and 11 days post-transplant

Bortezomib

Arm C (Experimental)

Drug: Bortezomib, Sirolimus, Tacrolimus Other Names: Velcade

Bortezomib intravenously 1,4 and 7 days post-transplant Sirolimus, intravenously and orally, Day -3 through 3-6 months post-transplant Tacrolimus, intravenously and orally, Day -3 through 3-6 months post-transplant

Sirolimus

Total Total of all reporting groups

Baseline Measures
   Arm A (Standard of Care)   Arm B (Experimental)   Arm C (Experimental)   Total 
Overall Participants Analyzed 
[Units: Participants]
 46   45   47   138 
Age 
[Units: Participants]
Count of Participants
       
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      19  41.3%      22  48.9%      29  61.7%      70  50.7% 
>=65 years      27  58.7%      23  51.1%      18  38.3%      68  49.3% 
Age 
[Units: Years]
Median (Full Range)
 65 
 (29 to 74) 
 65 
 (30 to 75) 
 62 
 (24 to 73) 
 64 
 (24 to 75) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      18  39.1%      13  28.9%      23  48.9%      54  39.1% 
Male      28  60.9%      32  71.1%      24  51.1%      84  60.9% 
Region of Enrollment 
[Units: Participants]
       
United States   46   45   47   138 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants With Incidence of Grade II-IV GVHD   [ Time Frame: 6 months ]

2.  Secondary:   Percentage of Participants With Non-relapse Mortality   [ Time Frame: 1 year ]

3.  Secondary:   Percentage of Participants With Relapse   [ Time Frame: 1 year ]

4.  Secondary:   Percentage of Participants With Progression-free and Overall Survival   [ Time Frame: 1 year ]

5.  Secondary:   Percentage of Participants With Chronic Graft Versus Host Disease   [ Time Frame: 1 year ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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: Dr. John Koreth
Organization: Dana Farber Cancer Institute
phone: 617-632-2949
e-mail: John_Koreth@dfci.harvard.edu



Responsible Party: John Koreth, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT01754389     History of Changes
Other Study ID Numbers: 12-404
First Submitted: December 13, 2012
First Posted: December 21, 2012
Results First Submitted: May 22, 2017
Results First Posted: July 18, 2017
Last Update Posted: July 18, 2017