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Antithymocyte Globulin, Clofarabine, and Rituximab in Treating Patients After an Unsuccessful Stem Cell Transplant

This study has been terminated.
(Replaced by another protocol)
Sponsor:
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier:
NCT00617929
First received: February 15, 2008
Last updated: November 22, 2016
Last verified: April 2015
Results First Received: September 28, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Cancer
Interventions: Biological: anti-thymocyte globulin
Biological: rituximab
Drug: clofarabine
Procedure: stem cell transplantation

  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
No text entered.

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
Conditioning for Graft Failure After Transplant Day -7: Rituximab 375 mg/m2 Day -6: Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -5: Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -4: Clofarabine 30 mg/m2 IV over 1 hour and Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -3: Clofarabine 30 mg/m2 IV over 1 hour Day -2: Clofarabine 30 mg/m2 IV over 1 hour Day -1: Rest Day 0: Stem Cell Infusion

Participant Flow:   Overall Study
    Conditioning for Graft Failure After Transplant
STARTED   12 
COMPLETED   11 
NOT COMPLETED   1 
Physician Decision                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.
No text entered.

Reporting Groups
  Description
Conditioning for Graft Failure After Transplant Day -7: Rituximab 375 mg/m2 Day -6: Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -5: Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -4: Clofarabine 30 mg/m2 IV over 1 hour and Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -3: Clofarabine 30 mg/m2 IV over 1 hour Day -2: Clofarabine 30 mg/m2 IV over 1 hour Day -1: Rest Day 0: Stem Cell Infusion

Baseline Measures
   Conditioning for Graft Failure After Transplant 
Overall Participants Analyzed 
[Units: Participants]
 12 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      6  50.0% 
Between 18 and 65 years      6  50.0% 
>=65 years      0   0.0% 
Gender 
[Units: Participants]
Count of Participants
 
Female      3  25.0% 
Male      9  75.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Rate of Sustained Donor Engraftment   [ Time Frame: Day 42 post transplantation ]

2.  Primary:   Survival at 100 Days Post Transplant   [ Time Frame: Day 100 post transplantation ]

3.  Secondary:   Treatment-related Death   [ Time Frame: Day 100 post transplantation ]

4.  Secondary:   Time to Primary Neutrophil Engraftment   [ Time Frame: Day 42 post transplantation ]

5.  Secondary:   Survival   [ Time Frame: One year post transplantation ]

6.  Secondary:   Chimerism   [ Time Frame: Day 28 post transplantation ]

7.  Secondary:   Acute Graft-vs-host Disease   [ Time Frame: Day 30-100 ]


  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: Jakub Tolar, MD
Organization: Masonic Cancer Center, University of Minnesota
phone: 612-624-7180
e-mail: tolar003@umn.edu



Responsible Party: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT00617929     History of Changes
Other Study ID Numbers: 2007LS072
UMN-MT2007-07 ( Other Identifier: Blood and Marrow Transplantation Program )
0707M11845 ( Other Identifier: IRB, University of Minnesota )
Study First Received: February 15, 2008
Results First Received: September 28, 2016
Last Updated: November 22, 2016