Combination Chemotherapy and Radiation Therapy in Treating Patients Who Are Undergoing an Autologous Stem Cell Transplant for Relapsed or Refractory Hodgkin's Lymphoma

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00255723
First received: November 18, 2005
Last updated: December 22, 2015
Last verified: December 2015
Results First Received: December 22, 2015  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Lymphoma
Interventions: Drug: carboplatin
Drug: etoposide
Drug: ifosfamide

  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
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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
Arm A Standard dose ICE x 1 cycle, followed by augmented ICE x 1 cycle (0-1 risk factors)
Arm B Augmented ICE x 2 cycles (2 risk factors)

Participant Flow:   Overall Study
    Arm A     Arm B  
STARTED     56     41  
COMPLETED     54     39  
NOT COMPLETED     2     2  
Adverse Event                 1                 1  
Death                 0                 1  
Response Data Not Available                 1                 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
Arm A Standard dose ICE x 1 cycle, followed by augmented ICE x 1 cycle (0-1 risk factors)
Arm B Augmented ICE x 2 cycles (2 risk factors)
Total Total of all reporting groups

Baseline Measures
    Arm A     Arm B     Total  
Number of Participants  
[units: participants]
  56     41     97  
Age  
[units: participants]
     
<=18 years     1     0     1  
Between 18 and 65 years     55     38     93  
>=65 years     0     3     3  
Gender  
[units: participants]
     
Female     35     21     56  
Male     21     20     41  



  Outcome Measures

1.  Primary:   Overall Objective Response   [ Time Frame: 3 years ]


  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. Craig Moskowitz
Organization: Memorial Sloan Kettering Cancer Center
phone: 212-639-7992
e-mail: moskowic@mskcc.org


No publications provided by Memorial Sloan Kettering Cancer Center

Publications automatically indexed to this study:

Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00255723     History of Changes
Other Study ID Numbers: 04-047
MSKCC-04047
Study First Received: November 18, 2005
Results First Received: December 22, 2015
Last Updated: December 22, 2015
Health Authority: United States: Institutional Review Board