Sirolimus, Mycophenolate Mofetil and Bortezomib as Graft-Versus-Host Disease (GVHD) Prophylaxis After Reduced Intensity Conditioning (RIC) Hematopoietic Stem Cell Transplantation

This study has been terminated.
(First two patients enrolled after trial reopened, developed grade III-IV acute GVHD and subsequently passed away.)
Sponsor:
Collaborators:
Wyeth is now a wholly owned subsidiary of Pfizer
PDL BioPharma, Inc.
Information provided by (Responsible Party):
Corey S. Cutler, MD, MPH, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00548717
First received: October 23, 2007
Last updated: October 20, 2014
Last verified: October 2014
Results First Received: September 29, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Graft-vs-Host Disease
Interventions: Drug: Sirolimus
Drug: Mycophenolate mofetil
Drug: Bortezomib

  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
Participants were recruited at Dana Farber Cancer Institute. The first participant was enrolled in November 2007. Enrollment was halted May 2008 due to an unacceptable rate of acute GVHD. The study reopened in November 2012 with addition of bortezomib. The last participant enrolled May 2013. The study was permanently closed to accural August 2013.

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
Siro/MMF

Sirolimus and Mycophenolate Mofetil as GVHD Prophylaxis

Sirolimus (Rapamycin) Mycophenolate Mofetil (MMF)

Siro/MMF/Bort

Sirolimus, Mycophenolate Mofetil, and Bortezomib for GVHD prophylaxis

Sirolimus (Rapamycin) Mycophenolate Mofetil (MMF) Bortezomib (Velcade)

*Bortezomib added when study reopened in November 2012


Participant Flow:   Overall Study
    Siro/MMF     Siro/MMF/Bort  
STARTED     13     2  
COMPLETED     4     0  
NOT COMPLETED     9     2  
Death                 5                 2  
Relapse                 3                 0  
Alternative treatment for GVHD                 1                 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
Siro/MMF

Sirolimus and Mycophenolate Mofetil as GVHD Prophylaxis

Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF);

Siro/MMF/Bort

Sirolimus, Mycophenolate Mofetil, and Bortezomib as GVHD Prophylaxis

Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF); Bortezomib (Velcade) *added with study reopening in 2012

Total Total of all reporting groups

Baseline Measures
    Siro/MMF     Siro/MMF/Bort     Total  
Number of Participants  
[units: participants]
  13     2     15  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     11     0     11  
>=65 years     2     2     4  
Gender  
[units: participants]
     
Female     4     0     4  
Male     9     2     11  
Region of Enrollment  
[units: participants]
     
United States     13     2     15  



  Outcome Measures
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1.  Primary:   To Determine the Rate of Grade II-IV Acute GVHD When Sirolimus and Mycophenolate Mofetil or Sirolimus, Mycophenolate Mofetil and Bortezomib is Used for GVHD Prophylaxis After Allogeneic Stem Cell Transplantation in Patients With Hematologic Malignancies   [ Time Frame: 150 days ]

2.  Secondary:   Donor Stem Cell Engraftment, Including Donor-host Hematopoietic Chimerism Studies Post Transplant   [ Time Frame: 30 days ]

3.  Secondary:   The Rate of Renal Insufficiency   [ Time Frame: 1 year ]

4.  Secondary:   To Correlate the Serum Concentrations of Mycophenolate Mofetil and Its Metabolites With Acute GVHD Incidence   [ Time Frame: 1 year ]

5.  Secondary:   Incidence of 100 Day Mortality   [ Time Frame: 100 days ]

6.  Secondary:   Incidence of Chronic GVHD   [ Time Frame: 1 year ]

7.  Secondary:   Overall Survival   [ Time Frame: 1 year ]


  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
Early termination leading to small numbers of subjects analyzed. Results are reported for transparency only, and should not be used to extrapolate significant conclusions.


  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. Corey Cutler
Organization: Dana Farber Cancer Institute
phone: 617-632-3470
e-mail: Corey_Cutler@dfci.harvard.edu


No publications provided


Responsible Party: Corey S. Cutler, MD, MPH, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00548717     History of Changes
Other Study ID Numbers: DFCI 07-197
Study First Received: October 23, 2007
Results First Received: September 29, 2014
Last Updated: October 20, 2014
Health Authority: United States: Institutional Review Board