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Combination Chemotherapy Followed by Radiation Therapy in Treating Young Patients With Newly Diagnosed Hodgkin's Lymphoma

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00302003
First received: March 9, 2006
Last updated: December 16, 2016
Last verified: August 2016
Results First Received: June 29, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Childhood Favorable Prognosis Hodgkin Lymphoma
Childhood Lymphocyte Depletion Hodgkin Lymphoma
Childhood Mixed Cellularity Hodgkin Lymphoma
Childhood Nodular Sclerosis Hodgkin Lymphoma
Stage I Childhood Hodgkin Lymphoma
Stage II Childhood Hodgkin Lymphoma
Interventions: Radiation: radiation therapy
Drug: doxorubicin hydrochloride
Drug: vincristine sulfate
Drug: prednisone
Drug: cyclophosphamide
Drug: ifosfamide
Drug: vinorelbine tartrate
Drug: dexamethasone
Drug: etoposide phosphate
Drug: cisplatin
Drug: cytarabine
Biological: filgrastim

  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
Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim

Treatment consists of 3 cycles of Doxorubicin hydrochloride IV (25 mg/m2) days 1 & 2, Vincristine sulfate IV (1.4 mg/m2 [max 2.8 mg]) Days 1 & 8, Prednisone orally (40 mg/m2) Days 1-7, Cyclophosphamide IV (600 mg/m2) Days 1 & 2, Filgrastim by mouth or IV (5 micrograms/kg/dose) 24 hours after Cyclophosphamide complete. See detailed description for remainder of therapy.

radiation therapy: Undergo radiation therapy

doxorubicin hydrochloride: Given IV

vincristine sulfate: Given IV

prednisone: Given orally

cyclophosphamide: Given IV

ifosfamide: Given IV

vinorelbine tartrate: Given IV

dexamethasone: Given IV

etoposide phosphate: Given IV

cisplatin: Given IV

cytarabine: Given IV

filgrastim: Given IV or subcutaneously


Participant Flow:   Overall Study
    Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim
STARTED   287 
COMPLETED   207 
NOT COMPLETED   80 
Lack of Efficacy                62 
Lost to Follow-up                1 
Physician Decision                2 
Withdrawal by Subject                5 
Ineligible                9 
Protocol Violation                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
Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim

Treatment consists of 3 cycles of Doxorubicin hydrochloride IV (25 mg/m2) days 1 & 2, Vincristine sulfate IV (1.4 mg/m2 [max 2.8 mg]) Days 1 & 8, Prednisone orally (40 mg/m2) Days 1-7, Cyclophosphamide IV (600 mg/m2) Days 1 & 2, Filgrastim by mouth or IV (5 micrograms/kg/dose) 24 hours after Cyclophosphamide complete. See detailed description for remainder of therapy.

radiation therapy: Undergo radiation therapy

doxorubicin hydrochloride: Given IV

vincristine sulfate: Given IV

prednisone: Given orally

cyclophosphamide: Given IV

ifosfamide: Given IV

vinorelbine tartrate: Given IV

dexamethasone: Given IV

etoposide phosphate: Given IV

cisplatin: Given IV

cytarabine: Given IV

filgrastim: Given IV or subcutaneously


Baseline Measures
   Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim 
Overall Participants Analyzed 
[Units: Participants]
 287 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      272  94.8% 
Between 18 and 65 years      15   5.2% 
>=65 years      0   0.0% 
Age 
[Units: Years]
Median (Full Range)
 15 
 (3 to 21) 
Gender 
[Units: Participants]
Count of Participants
 
Female      160  55.7% 
Male      127  44.3% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      43  15.0% 
Not Hispanic or Latino      227  79.1% 
Unknown or Not Reported      17   5.9% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      3   1.0% 
Asian      8   2.8% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      29  10.1% 
White      220  76.7% 
More than one race      0   0.0% 
Unknown or Not Reported      27   9.4% 
Region of Enrollment 
[Units: Participants]
 
United States   250 
Australia   3 
Canada   25 
Israel   1 
Mexico   1 
New Zealand   2 
Puerto Rico   4 
Switzerland   1 


  Outcome Measures
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1.  Primary:   Event Free Survival Without Receiving Radiation Therapy (EFSnoRT).   [ Time Frame: At 60 months ]

2.  Primary:   Intensive Therapy Free Survival (ITFS).   [ Time Frame: At 60 months ]

3.  Primary:   Event Free Survival (EFS)   [ Time Frame: At 60 months ]

4.  Secondary:   Overall Survival   [ Time Frame: At 60 months ]


  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:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Results Reporting Coordinator
Organization: Children's Oncology Group
phone: 626-447-0064
e-mail: resultsreportingcoordinator@childrensoncologygroup.org



Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00302003     History of Changes
Other Study ID Numbers: AHOD0431
NCI-2009-00377 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000459962 ( Other Identifier: Clinical Trials.gov )
U10CA098543 ( US NIH Grant/Contract Award Number )
COG-AHOD0431 ( Other Identifier: Children's Oncology Group )
Study First Received: March 9, 2006
Results First Received: June 29, 2016
Last Updated: December 16, 2016