Thymoglobulin and Total Lymphoid Irradiation for Hematologic Malignancies

This study has been completed.
Sponsor:
Collaborator:
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00476229
First received: May 17, 2007
Last updated: August 1, 2012
Last verified: August 2012
Results First Received: July 13, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Lymphoma
Leukemia
Interventions: Drug: Thymoglobulin
Radiation: Total Lymphoid Irradiation
Procedure: Peripheral Blood Stem Cell Infusion
Drug: Rituximab

  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
Recruitment period: July 14, 2006 to October 15, 2008. All patients were registered at UT MD Anderson Cancer Center.

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
Radiation + Chemotherapy + BSCT Total Lymphoid Irradiation (2 times) at 80 cGy daily for five days + Thymoglobulin 1.5 mg/kg intravenous 5 days + Rituximab 375 mg/m^2 intravenous on 4 different days + Blood stem cell transplant (BSCT)

Participant Flow:   Overall Study
    Radiation + Chemotherapy + BSCT  
STARTED     20  
COMPLETED     19  
NOT COMPLETED     1  
Progressive shortness of breath                 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
Radiation + Chemotherapy + BSCT Total Lymphoid Irradiation (2 times) at 80 cGy daily for five days + Thymoglobulin 1.5 mg/kg intravenous 5 days + Rituximab 375 mg/m^2 intravenous on 4 different days + Blood stem cell transplant (BSCT)

Baseline Measures
    Radiation + Chemotherapy + BSCT  
Number of Participants  
[units: participants]
  20  
Age  
[units: years]
Median ( Full Range )
  30  
  ( 20 to 40 )  
Gender  
[units: participants]
 
Female     10  
Male     10  
Region of Enrollment  
[units: participants]
 
United States     20  



  Outcome Measures

1.  Primary:   Composite Success Rate   [ Time Frame: Baseline to Day 100, assessment at Day 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
Early termination due to financial support.


  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: Chitra M. Hosing, MD/Associate Professor
Organization: UT MD Anderson Cancer Center
e-mail: gmccormi@mdanderson.org


No publications provided


Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00476229     History of Changes
Other Study ID Numbers: 2005-0892
Study First Received: May 17, 2007
Results First Received: July 13, 2011
Last Updated: August 1, 2012
Health Authority: United States: Institutional Review Board