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Bortezomib-based GVHD Prophylaxis After Allogeneic Transplant for Patients Without Matched Related Donors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
John Koreth, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT01323920
First received: March 24, 2011
Last updated: February 14, 2014
Last verified: February 2014
Results First Received: February 14, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Leukemia
Lymphoma
Myelodysplastic Syndrome
Intervention: Drug: Bortezomib, Tacrolimus, Methotrexate

  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
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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
Velcade/Tac/MTX

Drug: Bortezomib, Tacrolimus, Methotrexate

Other Names:

Velcade

Bortezomib 1.3 mg/m^2 IV Tacrolimus 0.05 mg/kg PO bid Methotrexate 15 mg/m^2 IV


Participant Flow:   Overall Study
    Velcade/Tac/MTX  
STARTED     34  
COMPLETED     29  
NOT COMPLETED     5  
Death                 5  



  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.
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Reporting Groups
  Description
Velcade/Tac/MTX

Drug: Bortezomib, Tacrolimus, Methotrexate

Other Names:

Velcade

Bortezomib 1.3 mg/m^2 IV Tacrolimus 0.05 mg/kg PO bid Methotrexate 15 mg/m^2 IV


Baseline Measures
    Velcade/Tac/MTX  
Number of Participants  
[units: participants]
  34  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     34  
>=65 years     0  
Gender  
[units: participants]
 
Female     14  
Male     20  
Region of Enrollment  
[units: participants]
 
United States     34  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Cumulative Incidence of Grade II-IV Acute GVHD by Day 100 After Stem Cell Infusion   [ Time Frame: 2 years ]

2.  Secondary:   To Assess Percentage Donor Engraftment by Day 30 Post Stem Cell Infusion   [ Time Frame: 2 years ]

3.  Secondary:   To Assess Non-relapse Mortality, Progression-free and Overall Survival by 1 Year After Stem Cell Infusion   [ Time Frame: 2 years ]

4.  Secondary:   To Determine the Cumulative Incidence of Chronic GVHD Requiring Systemic Immune Suppression by 1 Year After Stem Cell Infusion   [ Time Frame: 2 years ]


  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
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  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


No publications provided


Responsible Party: John Koreth, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT01323920     History of Changes
Other Study ID Numbers: 11-007
Study First Received: March 24, 2011
Results First Received: February 14, 2014
Last Updated: February 14, 2014
Health Authority: United States: Food and Drug Administration