T-Cell Depleted Allogeneic Stem Cell Transplantation for Patients With Hematologic Malignancies

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00683046
First received: May 21, 2008
Last updated: August 6, 2015
Last verified: August 2015
Results First Received: February 14, 2014  
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
Lymphoid Leukemia
Chronic Myelogenous Leukemia
Malignant Lymphoma
Hodgkin's Disease
Chronic Lymphocytic Leukemia
Myeloproliferative Disorder
Anemia, Aplastic
Myelodysplastic Syndromes
Interventions: Drug: Fludarabine
Drug: Melphalan
Drug: Stem cells
Drug: Campath

  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
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Reporting Groups
  Description
T-cell Depleted Allogeneic Stem Cell Transplantation

All patients were administered the following drugs;

  1. Fludarabine 30mg/m2 intravenously daily at the same time over 30 min on days -7,-6,-5,-4, and -3
  2. Melphalan 140mg/m2 IV on day -2
  3. Stem cell infusion on day 0
  4. Campath 20mg IV on day -7,-6,-5,-4, and -3

Participant Flow:   Overall Study
    T-cell Depleted Allogeneic Stem Cell Transplantation  
STARTED     204  
COMPLETED     204  
NOT COMPLETED     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.
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Reporting Groups
  Description
T-cell Depleted Allogeneic Stem Cell Transplantation

All patients were administered the following drugs;

  1. Fludarabine 30mg/m2 intravenously daily at the same time over 30 min on days -7,-6,-5,-4, and -3
  2. Melphalan 140mg/m2 IV on day -2
  3. Stem cell infusion on day 0
  4. Campath 20mg IV on day -7,-6,-5,-4, and -3

Baseline Measures
    T-cell Depleted Allogeneic Stem Cell Transplantation  
Number of Participants  
[units: participants]
  204  
Age  
[units: years]
Mean (Standard Deviation)
  51.0  (12.0)  
Gender  
[units: participants]
 
Female     93  
Male     111  



  Outcome Measures
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1.  Primary:   Median Disease-free Survival   [ Time Frame: Patients evaluated continuously with disease specific re-evaluation at day 30, 3 months, 6 months, 1 year, and as indicated thereafter ]

2.  Secondary:   Median Overall Survival   [ Time Frame: Patients evaluated continuously with disease specific re-evaluation at day 30, 3 months, 6 months, 1 year, and as indicated thereafter ]


  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. Andrew Artz
Organization: University of Chicago Medicine
phone: 773-834-8980
e-mail: aartz@medicine.bsd.uchicago.edu


No publications provided


Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00683046     History of Changes
Other Study ID Numbers: 11300A
Study First Received: May 21, 2008
Results First Received: February 14, 2014
Last Updated: August 6, 2015
Health Authority: United States: Institutional Review Board