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Bortezomib Plus Tacrolimus and Methotrexate to Prevent Graft Versus Host Disease (GVHD) After Mismatched Allogeneic Non-Myeloablative Blood Stem Cell Transplantation

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ClinicalTrials.gov Identifier: NCT00369226
Recruitment Status : Completed
First Posted : August 29, 2006
Results First Posted : July 25, 2013
Last Update Posted : July 25, 2013
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition: Hematologic Malignancies
Interventions: Drug: Bortezomib (Velcade)
Drug: Tacrolimus
Drug: Methotrexate
Procedure: blood stem cell transplantation

  Participant Flow

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
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Reporting Groups
  Description
Phase I (45 Days) Bortezomib plus tacrolimus and methotrexate after mismatched allogeneic non-myeloablative hematopoietic stem cell transplantation (HSCT).
Phase II (45 Days) No text entered.

Participant Flow for 2 periods

Period 1:   Phase I (45 Days)
    Phase I (45 Days)   Phase II (45 Days)
STARTED   13   0 
COMPLETED   13 [1]   0 
NOT COMPLETED   0   0 
[1] Once MTD established, additional 10 patients were accrued at MTD to better estimate toxicity.

Period 2:   Phase II (45 Days)
    Phase I (45 Days)   Phase II (45 Days)
STARTED   0   32 
COMPLETED   0   32 [1] 
NOT COMPLETED   0   0 
[1] This includes 10 patients treated at candidate MTD in Phase I.



  Baseline Characteristics

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.
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Reporting Groups
  Description
Phase I No text entered.
Phase II No text entered.
Total Total of all reporting groups

Baseline Measures
   Phase I   Phase II   Total 
Overall Participants Analyzed 
[Units: Participants]
 13   32   45 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   13   25   38 
>=65 years   0   7   7 
Gender 
[Units: Participants]
     
Female   7   14   21 
Male   6   18   24 
Region of Enrollment 
[Units: Participants]
     
United States   13   32   45 


  Outcome Measures

1.  Primary:   The Maximally Tolerated Dose (MTD) of Bortezomib (Velcade) That Can be Administered With Tacrolimus and Methotrexate After Mismatched Allogeneic Non-myeloablative Peripheral Blood Stem Cell (PBSC) Transplantation   [ Time Frame: by day 45 post PBSC infusion ]

2.  Primary:   Successful Initial Engraftment by Day 45 Post Peripheral Blood Stem Cell (PBSC) Infusion and Administration of Bortezomib (Velcade), Tacrolimus and Methotrexate   [ Time Frame: by day 45 post PBSC infusion ]

3.  Primary:   Incidence of Grade II-IV Acute Graft Versus Host Disease (GVHD) by Day 100.   [ Time Frame: by day 100 after peripheral blood stem cell (PBSC) infusion ]

4.  Secondary:   Sustained Engraftment Following Transplant.   [ Time Frame: by day 100 post transplant ]

5.  Secondary:   Incidence of Chronic Graft Versus Host Disease (Chronic GVHD).   [ Time Frame: by 1 year after PBSC infusion ]

6.  Secondary:   Overall Survival and Progression-free Survival.   [ Time Frame: by 1 year after PBSC infusion ]


  Serious Adverse Events


  Other Adverse Events


  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
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  More Information

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


Results Point of Contact:  
Name/Title: John Koreth, MBBS, D.Phil
Organization: Dana-Farber Cancer Institute
phone: (617) 632-2949
e-mail: jkoreth@partners.org


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: John Koreth, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00369226     History of Changes
Other Study ID Numbers: 06-065
X05175
First Submitted: August 24, 2006
First Posted: August 29, 2006
Results First Submitted: August 8, 2012
Results First Posted: July 25, 2013
Last Update Posted: July 25, 2013