Rituximab to the Preparative Regimen of Etoposide and Total Body Irradiation in Acute Lymphoblastic Leukemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00427791
First received: January 25, 2007
Last updated: April 10, 2012
Last verified: April 2012
Results First Received: January 19, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Leukemia
Interventions: Drug: Etoposide
Radiation: Total Body Irradiation
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 05, 2005 to August 08, 2008. All participants were enrolled 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
Etoposide + Total Body Irradiation + Rituximab Etoposide 60 mg/kg intravenous (IV) Daily Over 4 Hours for 1 Day + Total Body Irradiation (TBI) 3 Gy Daily for 4 Days + Rituximab 375 mg/m^2 IV Weekly Over 4-8 Hours for 4 Weeks
Etoposide + Total Body Irradiation Etoposide 60 mg/kg IV Daily Over 4 Hours for 1 Day + TBI 3 Gy Daily for 4 Days

Participant Flow:   Overall Study
    Etoposide + Total Body Irradiation + Rituximab     Etoposide + Total Body Irradiation  
STARTED     10     13  
COMPLETED     10     13  
NOT COMPLETED     0     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.
No text entered.

Reporting Groups
  Description
Etoposide + Total Body Irradiation + Rituximab Etoposide 60 mg/kg intravenous (IV) Daily Over 4 Hours for 1 Day + Total Body Irradiation (TBI) 3 Gy Daily for 4 Days + Rituximab 375 mg/m^2 IV Weekly Over 4-8 Hours for 4 Weeks
Etoposide + Total Body Irradiation Etoposide 60 mg/kg IV Daily Over 4 Hours for 1 Day + TBI 3 Gy Daily for 4 Days
Total Total of all reporting groups

Baseline Measures
    Etoposide + Total Body Irradiation + Rituximab     Etoposide + Total Body Irradiation     Total  
Number of Participants  
[units: participants]
  10     13     23  
Age  
[units: participants]
     
<=18 years     0     1     1  
Between 18 and 65 years     10     12     22  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     3     4     7  
Male     7     9     16  
Region of Enrollment  
[units: participants]
     
United States     10     13     23  



  Outcome Measures
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1.  Primary:   Progression-free Survival (PFS)   [ Time Frame: 2 Years post transplant or until disease progression or death ]

2.  Secondary:   Number of Participants With Incidence of Acute Graft Versus Host Disease During First 100 Days   [ Time Frame: During the first 100 days following transplant ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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.  


Results Point of Contact:  
Name/Title: Dr. Partow Kebriaei, Associate Professor
Organization: UT MD Anderson Cancer Center
phone: 713-792-2648
e-mail: ytdinh@mdanderson.org


No publications provided


Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00427791     History of Changes
Other Study ID Numbers: 2004-0989
Study First Received: January 25, 2007
Results First Received: January 19, 2012
Last Updated: April 10, 2012
Health Authority: United States: Institutional Review Board