Trial record 1 of 1 for:    NCT00145600
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Therapy for Pediatric Hodgkin Lymphoma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT00145600
First received: September 2, 2005
Last updated: July 29, 2013
Last verified: February 2013
Results First Received: February 12, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hodgkin Lymphoma
Interventions: Drug: 12 Week Stanford V Chemotherapy
Drug: 4 cycles of VAMP chemotherapy
Drug: 2 alternating cycles of VAMP/COP chemotherapy
Drug: 3 alternating cycles of VAMP/COP chemotherapy

  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
296 patients were enrolled from 5 institutions between March 2000 and May 2011.

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
Favorable Risk

Ann Arbor stage IA or IIA with:

  1. Non-bulky mediastinal disease (<33% mediastinal to thoracic ratio on chest x-ray)
  2. < 3 nodal regions involved on the same side of the diaphragm
  3. No extranodal extension of disease
Intermediate Risk

Stage must be classified as one of the following:

  1. Ann Arbor stage IB and IIIA
  2. Ann Arbor stage IA or IIA with ANY of the following features: (1) extranodal extension of disease lesion(s), (2) 3 or more nodal sites involved, (3) Bulky mediastinal adenopathy (mediastinal mass to thoracic cavity ratio 33% or greater by chest radiograph)
Unfavorable Risk, Group 1 Unfavorable risk group 1 closed early due to excessive number of adverse events (n=13).
Unfavorable Risk, Group 2

Stage must be classified as one of the following:

a. Ann Arbor stage IIB, IIIB, or any IV


Participant Flow:   Overall Study
    Favorable Risk     Intermediate Risk     Unfavorable Risk, Group 1     Unfavorable Risk, Group 2  
STARTED     91     46     13     146  
COMPLETED     83     36     8     130  
NOT COMPLETED     8     10     5     16  
Death                 1                 2                 2                 6  
Ineligible                 3                 0                 1                 5  
Lost to Follow-up                 2                 6                 2                 4  
Noncompliance                 1                 0                 0                 0  
Withdrawal by Subject                 1                 2                 0                 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
Favorable Risk

Ann Arbor stage IA or IIA with:

  1. Non-bulky mediastinal disease (<33% mediastinal to thoracic ratio on chest x-ray)
  2. < 3 nodal regions involved on the same side of the diaphragm
  3. No extranodal extension of disease
Intermediate Risk

Stage must be classified as one of the following:

  1. Ann Arbor stage IB and IIIA
  2. Ann Arbor stage IA or IIA with ANY of the following features: (1) extranodal extension of disease lesion(s), (2) 3 or more nodal sites involved, (3) Bulky mediastinal adenopathy (mediastinal mass to thoracic cavity ratio 33% or greater by chest radiograph)
Unfavorable Risk, Group 1 Unfavorable risk group 1 closed early due to excessive number of adverse events (n=13).
Unfavorable Risk, Group 2

Stage must be classified as one of the following:

a. Ann Arbor stage IIB, IIIB, or any IV

Total Total of all reporting groups

Baseline Measures
    Favorable Risk     Intermediate Risk     Unfavorable Risk, Group 1     Unfavorable Risk, Group 2     Total  
Number of Participants  
[units: participants]
  91     46     13     146     296  
Age  
[units: participants]
         
<=18 years     84     36     11     122     253  
Between 18 and 65 years     7     10     2     24     43  
>=65 years     0     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  13.08  ± 3.91     15.35  ± 3.28     14.85  ± 3.21     15.06  ± 3.37     14.48  ± 3.63  
Gender  
[units: participants]
         
Female     32     26     5     80     143  
Male     59     20     8     66     153  



  Outcome Measures
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1.  Primary:   Event-free Survival Probability by Risk Group   [ Time Frame: Median 6.4 year follow-up ]

2.  Secondary:   Correlation of Agreement Between Patient Physical QoL and Parent Proxy Physical QoL at Multiple Time Points.   [ Time Frame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5). ]

3.  Secondary:   Correlation of Agreement Between Patient Emotional QoL and Parent Proxy Emotional QoL at Multiple Time Points.   [ Time Frame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5). ]

4.  Secondary:   Correlation of Agreement Between Patient Social QoL and Parent Proxy Social QoL at Multiple Time Points.   [ Time Frame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5). ]

5.  Secondary:   Correlation of Agreement Between Patient School QoL and Parent Proxy School QoL at Multiple Time Points.   [ Time Frame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5). ]

6.  Secondary:   Correlation of Agreement Between Patient Psychosocial QoL and Parent Proxy Psychosocial QoL at Multiple Time Points.   [ Time Frame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5). ]

7.  Secondary:   Correlation of Agreement Between Patient Peds QL4 (Composite) QoL and Parent Proxy Peds QL4 (Composite) QoL at Multiple Time Points.   [ Time Frame: At Diagnosis (T1), completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5). ]

8.  Secondary:   Correlation of Agreement Between Patient Pain and Hurt QoL and Parent Proxy Pain and Hurt QoL at Multiple Time Points.   [ Time Frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5). ]

9.  Secondary:   Correlation of Agreement Between Patient Nausea QoL and Parent Proxy Nausea QoL at Multiple Time Points.   [ Time Frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5) ]

10.  Secondary:   Correlation of Agreement Between Patient Procedural Anxiety QoL and Parent Proxy Procedural Anxiety QoL at Multiple Time Points.   [ Time Frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5) ]

11.  Secondary:   Correlation of Agreement Between Patient Treatment Anxiety QoL and Parent Proxy Treatment Anxiety QoL at Multiple Time Points.   [ Time Frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5) ]

12.  Secondary:   Correlation of Agreement Between Patient Worry QoL and Parent Proxy Worry QoL at Multiple Time Points.   [ Time Frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5) ]

13.  Secondary:   Correlation of Agreement Between Patient Cognitive Problems (Child + Teen) QoL and Parent Proxy Cognitive Problems (Child + Teen) QoL at Multiple Time Points.   [ Time Frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5) ]

14.  Secondary:   Correlation of Agreement Between Patient Perceived Physical Appearance QoL and Parent Proxy Perceived Physical Appearance QoL at Multiple Time Points.   [ Time Frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5) ]

15.  Secondary:   Correlation of Agreement Between Patient Communication QoL and Parent Proxy Communication QoL at Multiple Time Points.   [ Time Frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5) ]

16.  Secondary:   Correlation of Agreement Between Patient PedsQL3 (Composite) QoL and Parent Proxy PedsQL3 (Composite) QoL at Multiple Time Points.   [ Time Frame: At completion of 2 cycles of chemotherapy (T2), completion of 4 cycles of chemotherapy (T3), and 3-6 months after the completion of therapy (T5) ]


  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: Monika Metzger, MD
Organization: St. Jude Children's Research Hospital
phone: 1-866-278-5833
e-mail: info@stjude.org


No publications provided by St. Jude Children's Research Hospital

Publications automatically indexed to this study:

Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT00145600     History of Changes
Other Study ID Numbers: HOD99
Study First Received: September 2, 2005
Results First Received: February 12, 2013
Last Updated: July 29, 2013
Health Authority: United States: Institutional Review Board