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Combination Chemotherapy and Radiation Therapy in Treating Young Patients With Newly Diagnosed Hodgkin Lymphoma

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT01026220
First received: December 3, 2009
Last updated: April 18, 2017
Last verified: February 2017
Results First Received: February 8, 2017  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: No masking;   Primary Purpose: Treatment
Conditions: Childhood Nodular Lymphocyte Predominant Hodgkin Lymphoma
Stage III Childhood Hodgkin Lymphoma
Stage IV Childhood Hodgkin Lymphoma
Interventions: Biological: bleomycin sulfate
Drug: doxorubicin hydrochloride
Drug: liposomal vincristine sulfate
Drug: vinorelbine tartrate
Drug: cyclophosphamide
Drug: etoposide phosphate
Drug: prednisone
Biological: filgrastim
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
No text entered.

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
INDUCTION THERAPY (ABVE-PC) All Patients
REGIMEN I (RER) Patients receive 2 more courses of ABVE-PC in the absence of unacceptable toxicity or disease progression.
REGIMEN II (SER) Patients receive ifosfamide IV continuously on days 1-4, vinorelbine ditartrate IV over 6-30 minutes on days 1 and 5, and filgrastim SC or IV daily beginning on day 6 and continuing until blood counts recover. Treatment repeats every 21 days for 2 courses in the absence of unacceptable toxicity or disease progression. Patients then receive 2 more courses of ABVE-PC in the absence of unacceptable toxicity or disease progression.

Participant Flow for 2 periods

Period 1:   Induction
    INDUCTION THERAPY (ABVE-PC)   REGIMEN I (RER)   REGIMEN II (SER)
STARTED   166   0   0 
COMPLETED   141   0   0 
NOT COMPLETED   25   0   0 
Death                1                0                0 
Lack of Efficacy                2                0                0 
Physician Decision                12                0                0 
Withdrawal by Subject                9                0                0 
Ineligible                1                0                0 

Period 2:   Consolidation Maintenance
    INDUCTION THERAPY (ABVE-PC)   REGIMEN I (RER)   REGIMEN II (SER)
STARTED   0   81   80 
COMPLETED   0   75   66 
NOT COMPLETED   0   6   14 
Death                0                1                0 
Lack of Efficacy                0                1                1 
Physician Decision                0                2                7 
Withdrawal by Subject                0                2                6 



  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
INDUCTION THERAPY (ABVE-PC) All Patients

Baseline Measures
   INDUCTION THERAPY (ABVE-PC) 
Overall Participants Analyzed 
[Units: Participants]
 166 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      156  94.0% 
Between 18 and 65 years      10   6.0% 
>=65 years      0   0.0% 
Age 
[Units: Years]
Median (Full Range)
 15 
 (5 to 21) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      64  38.6% 
Male      102  61.4% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      33  19.9% 
Not Hispanic or Latino      129  77.7% 
Unknown or Not Reported      4   2.4% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      2   1.2% 
Asian      7   4.2% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      26  15.7% 
White      112  67.5% 
More than one race      0   0.0% 
Unknown or Not Reported      19  11.4% 
Region of Enrollment 
[Units: Participants]
 
Canada   19 
United States   143 
Australia   3 
Puerto Rico   1 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Second-event-free Survival   [ Time Frame: At 4 years from enrollment ]

2.  Primary:   Safety Analysis and Monitoring of Toxic Death   [ Time Frame: Within 30 days of protocol treatment at median follow-up of 48 months (range: 1 to 70 months). ]

3.  Secondary:   Event Free Survival   [ Time Frame: At 3 years from enrollment ]

4.  Secondary:   Second-event-free Survival   [ Time Frame: At 4 years from enrollment ]

5.  Secondary:   Event-free Survival for Rapid Early Response (RER) Positron Emission Tomography(PET)-1 Positive, RER PET-1 Negative   [ Time Frame: 3 years from enrollment ]

6.  Secondary:   Relapse-free Survival   [ Time Frame: 3 years from enrollment ]

7.  Secondary:   Event Free Survival   [ Time Frame: At 3 years from enrollment ]

8.  Secondary:   Grade 3 and 4 Non-hematologic Toxicities During Protocol Therapy   [ Time Frame: During and after completion of study treatment. ]

9.  Secondary:   Overall Survival   [ Time Frame: At 3 years from enrollment ]


  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
No text entered.


  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: NCT01026220     History of Changes
Other Study ID Numbers: AHOD0831
NCI-2011-01994 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000660550
AHOD0831 ( Other Identifier: Children's Oncology Group )
AHOD0831 ( Other Identifier: CTEP )
U10CA098543 ( US NIH Grant/Contract Award Number )
Study First Received: December 3, 2009
Results First Received: February 8, 2017
Last Updated: April 18, 2017