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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:
ClinicalTrials.gov Identifier:
NCT00255723
First Posted: November 21, 2005
Last Update Posted: February 1, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
Results First Submitted: December 22, 2015  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (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 
Overall Participants Analyzed 
[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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00255723     History of Changes
Other Study ID Numbers: 04-047
MSKCC-04047
First Submitted: November 18, 2005
First Posted: November 21, 2005
Results First Submitted: December 22, 2015
Results First Posted: February 1, 2016
Last Update Posted: February 1, 2016