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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00683046
First received: May 21, 2008
Last updated: February 14, 2014
Last verified: February 2014
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
  Hide Participant Flow

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
T-cell Depleted Allogeneic Stem Cell Transplantation T-cell depletion and non-myelo-ablative ablative stem cell transplantation in patients with hematologic malignancies

Participant Flow:   Overall Study
    T-cell Depleted Allogeneic Stem Cell Transplantation  
STARTED     204  
COMPLETED     204  
NOT COMPLETED     0  



  Baseline Characteristics
  Hide Baseline Characteristics

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
T-cell Depleted Allogeneic Stem Cell Transplantation T-cell depletion and non-myelo-ablative ablative stem cell transplantation in patients with hematologic malignancies

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
  Show All Outcome Measures

1.  Primary:   Median Disease-free Survival   [ Time Frame: 10 years ]

2.  Secondary:   Median Overall Survival   [ Time Frame: 10 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

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: February 14, 2014
Health Authority: United States: Institutional Review Board