Basiliximab #2: In-Vivo Activated T-Cell Depletion to Prevent Graft-Versus_Host Disease (GVHD) After Nonmyeloablative Allotransplantation for the Treatment of Blood Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Indiana University ( Indiana University School of Medicine )
ClinicalTrials.gov Identifier:
NCT00975975
First received: September 11, 2009
Last updated: January 28, 2016
Last verified: January 2016
Results First Received: January 28, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Acute Myelogenous Leukemia
Acute Lymphocytic Leukemia
Chronic Myelogenous Leukemia
Chronic Lymphocytic Leukemia
Myelodysplasia
Non-Hodgkin's Lymphoma
Hodgkin's Disease
Multiple Myeloma
Myelofibrosis
Anemia, Aplastic
Hemoglobinuria, Paroxysmal
Intervention: Drug: Basiliximab

  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
This protocol has 17 patients. The study was stopped prior to 20 due to the meeting of a stopping rule of 5 or more deaths within the first 15 patients. An additional patient was enrolled after the stopping rule was met. This patient was followed for safety/AE but is not included in the analysis of the efficacy measures, as recommended by the IRB.

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
Overall Patients administered 40 mg of basiliximab as a single intravenous dose on day +7, +8, or +9 following infusion of allogeneic peripheral blood hematopoietic cells

Participant Flow:   Overall Study
    Overall  
STARTED     17  
COMPLETED     11  
NOT COMPLETED     6  
Death                 6  



  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
Overall Patients administered 40 mg of basiliximab as a single intravenous dose on day +7, +8, or +9 following infusion of allogeneic peripheral blood hematopoietic cells

Baseline Measures
    Overall  
Number of Participants  
[units: participants]
  17  
Age  
[units: years]
Mean (Standard Deviation)
  59.1  (7.05)  
Gender  
[units: participants]
 
Female     8  
Male     9  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     0  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     0  
White     17  
More than one race     0  
Unknown or Not Reported     0  



  Outcome Measures
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1.  Primary:   Grade 3-4 Acute GVHD Rate   [ Time Frame: Transplant (Day 0) up to 1 year ]

2.  Secondary:   Time to Neutrophil Engraftment   [ Time Frame: Transplant (Day 0) up to 1 year ]

3.  Secondary:   Time to Platelet Engraftment   [ Time Frame: Transplant (Day 0) up to 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
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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. Robert Nelson
Organization: IndianaU
phone: 317-944-0920
e-mail: ronelson@iu.edu



Responsible Party: Indiana University ( Indiana University School of Medicine )
ClinicalTrials.gov Identifier: NCT00975975     History of Changes
Other Study ID Numbers: 0908-04; IUCRO-0256
Study First Received: September 11, 2009
Results First Received: January 28, 2016
Last Updated: January 28, 2016
Health Authority: United States: Institutional Review Board