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Trial record 2 of 3 for:    windreich

Pharmacokinetics-based Mycophenolate Mofetil Dosing for GVHD Prevention

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01487577
First Posted: December 7, 2011
Last Update Posted: June 21, 2016
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):
Randy Windreich, University of Pittsburgh
Results First Submitted: February 24, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Allogeneic Blood and Marrow Transplantation (BMT)
Graft Versus Host Disease
Intervention: Drug: Mycophenolate mofetil

  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
Candidates are identified through the investigators' clinical practice.

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
Mycophenolate Mofetil Pharmacokinetics-based targeting of Mycophenolate mofetil

Participant Flow:   Overall Study
    Mycophenolate Mofetil
STARTED   19 
COMPLETED   18 [1] 
NOT COMPLETED   1 
Became ineligible after signing consent                1 
[1] One participant became ineligible after signing consent, but before receiving protocol therapy.



  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.
Pediatric hematopoietic stem cell recipients undergoing myeloablative conditioning therapy

Reporting Groups
  Description
Mycophenolate Mofetil

Pharmacokinetics-based targeting of mycophenolate mofetil

Mycophenolate mofetil: Based on individual pharmacokinetics data, mycophenolate mofetil will be administered by continuous infusion to target a desired AUC exposure


Baseline Measures
   Mycophenolate Mofetil 
Overall Participants Analyzed 
[Units: Participants]
 19 
Age 
[Units: Participants]
 
<=18 years   16 
Between 18 and 65 years   3 
>=65 years   0 
Gender 
[Units: Participants]
 
Female   10 
Male   9 
Race (NIH/OMB) 
[Units: Participants]
 
American Indian or Alaska Native   0 
Asian   2 
Native Hawaiian or Other Pacific Islander   0 
Black or African American   1 
White   15 
More than one race   1 
Unknown or Not Reported   0 
Region of Enrollment 
[Units: Participants]
 
United States   19 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Grade ≥3 Toxicities Scored According to the CTCAE Version 4.0.   [ Time Frame: 100 days ]

2.  Primary:   Number of Participants With Acute Grade II-IV GVHD, Acute Grade III-IV GVHD, and Chronic GVHD.   [ Time Frame: 1 year ]

3.  Secondary:   Number of Participants With Neutrophil and Platelet Engraftment.   [ Time Frame: 100 days ]

4.  Secondary:   Number of Participants Who Experienced Relapse.   [ Time Frame: 1 year ]

5.  Secondary:   Number of Participants Who Experienced Nonrelapse Mortality.   [ Time Frame: 1 year ]

6.  Secondary:   Number of Participants in Overall Survival.   [ Time Frame: 1 year ]

7.  Secondary:   Pharmacokinetic Analysis of MMF AUC to Evaluate MMF Dose Relationships to Drug Exposure.   [ Time Frame: 100 days ]

8.  Secondary:   Pharmacokinetic Analysis of MMF Clearance to Evaluate MMF Dose Relationships to Drug Exposure.   [ Time Frame: 100 days ]

9.  Secondary:   Pharmacokinetic Analysis of MMF Steady State Concentration to Evaluate MMF Dose Relationships to Drug Exposure.   [ Time Frame: 100 days ]


  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
Our study is limited by small sample size and heterogeneity in stem cell sources. Besides targeted MMF dosing, other factors that might have affected clinical outcomes include duration of MMF and use of ATG in unrelated-donor transplants.


  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: Randy M. Windreich, MD
Organization: Children's Hospital of Pittsburgh of UPMC
phone: 412-692-5225
e-mail: randy.windreich@chp.edu



Responsible Party: Randy Windreich, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01487577     History of Changes
Other Study ID Numbers: CHP_BMT_MMF_10
First Submitted: November 23, 2011
First Posted: December 7, 2011
Results First Submitted: February 24, 2016
Results First Posted: June 21, 2016
Last Update Posted: June 21, 2016