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Sirolimus & Mycophenolate Mofetil as GvHD Prophylaxis in Myeloablative, Matched Related Donor HCT

This study has been terminated.
(Low accrual)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01220297
First Posted: October 13, 2010
Last Update Posted: June 5, 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):
Laura Johnston, Stanford University
Results First Submitted: March 13, 2017  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Hematologic Diseases
Acute-graft-versus-host Disease
Leukemia
Non-Hodgkin Lymphoma (NHL)
Hodgkin Lymphoma
Interventions: Drug: Sirolimus
Drug: Mycophenolate mofetil (MMF)
Drug: Carmustine
Drug: Etoposide
Drug: Cyclophosphamide (Cyclo, CY)
Drug: FTBI

  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
Graft-vs-Host Disease (GvHD) Prophlyaxis Sirolimus & Mycophenolate Mofetil as GvHD Prophylaxis in Myeloablative

Participant Flow:   Overall Study
    Graft-vs-Host Disease (GvHD) Prophlyaxis
STARTED   3 
COMPLETED   0 
NOT COMPLETED   3 
Death                2 
Lost to Follow-up                1 



  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
GvHD Prophylaxis of Sirolimus & MMF After BCNU+VP16+Cyclo Graft-vs-host disease (GvHD) prophylaxis of sirolimus & mycophenolate mofetil (MMF) after chemotherapeutic regimen of carmustine (BCNU) + etoposide (VP-16) + cyclophosphamide (Cyclo)
GvHD Prophylaxis of Sirolimus & MMF After FTBI + Cyclo Graft-vs-host disease (GvHD) prophylaxis of sirolimus & mycophenolate mofetil (MMF) after therapeutic regimen of cyclophosphamide (Cyclo) chemotherapy and fractionated total body irradiation (FTBI)
Total Total of all reporting groups

Baseline Measures
   GvHD Prophylaxis of Sirolimus & MMF After BCNU+VP16+Cyclo   GvHD Prophylaxis of Sirolimus & MMF After FTBI + Cyclo   Total 
Overall Participants Analyzed 
[Units: Participants]
 0   3   3 
Age 
[Units: Participants]
Count of Participants
     
<=18 years         0   0.0%      0   0.0% 
Between 18 and 65 years         3 100.0%      3 100.0% 
>=65 years         0   0.0%      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female         0   0.0%      0   0.0% 
Male   0      3 100.0%      3 100.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino         1  33.3%      1  33.3% 
Not Hispanic or Latino         1  33.3%      1  33.3% 
Unknown or Not Reported         1  33.3%      1  33.3% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native         0   0.0%      0   0.0% 
Asian         1  33.3%      1  33.3% 
Native Hawaiian or Other Pacific Islander         0   0.0%      0   0.0% 
Black or African American         0   0.0%      0   0.0% 
White         0   0.0%      0   0.0% 
More than one race         0   0.0%      0   0.0% 
Unknown or Not Reported         2  66.7%      2  66.7% 
Disease Characteristics 
[Units: Participants]
Count of Participants
     
Acute Lymphoblastic Leukemia (ALL)      1   1 
Acute Myeloid Leukemia (AML)      1   1 
Biphenotypic Acute Leukaemia (BAL)      1   1 


  Outcome Measures
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1.  Primary:   Acute Graft-vs-Host Disease (GvHD) (Grade 2 to 4)   [ Time Frame: 100 days post-transplant ]

2.  Secondary:   Acute GvHD (Grade 3 to 4)   [ Time Frame: 100 days post-transplant ]

3.  Secondary:   Disease-free Survival (DFS)   [ Time Frame: 2 years ]

4.  Secondary:   Overall Survival   [ Time Frame: 2 years ]

5.  Secondary:   Veno-occlusive Disease (VoD)   [ Time Frame: 100 days post-transplant ]


  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:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Laura Johnston, MD
Organization: Stanford Univesity
phone: 650-723-0822
e-mail: laura.johnston@stanford.edu



Responsible Party: Laura Johnston, Stanford University
ClinicalTrials.gov Identifier: NCT01220297     History of Changes
Other Study ID Numbers: IRB-14913
SU-09092009-3841 ( Other Identifier: Stanford University )
BMT209 ( Other Identifier: OnCore )
First Submitted: November 24, 2009
First Posted: October 13, 2010
Results First Submitted: March 13, 2017
Results First Posted: June 5, 2017
Last Update Posted: June 5, 2017