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

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ClinicalTrials.gov Identifier: NCT00302003
Recruitment Status : Completed
First Posted : March 13, 2006
Results First Posted : February 9, 2017
Last Update Posted : March 30, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (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
Enrollment 287
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim
Hide Arm/Group Description

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

Period Title: Overall Study
Started 287
Completed 207
Not Completed 80
Reason Not Completed
Lack of Efficacy             62
Lost to Follow-up             1
Physician Decision             2
Withdrawal by Subject             5
Ineligible             9
Protocol Violation             1
Arm/Group Title Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim
Hide Arm/Group Description

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

Overall Number of Baseline Participants 287
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 287 participants
<=18 years
272
  94.8%
Between 18 and 65 years
15
   5.2%
>=65 years
0
   0.0%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 287 participants
15
(3 to 21)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 287 participants
Female
160
  55.7%
Male
127
  44.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 287 participants
Hispanic or Latino
43
  15.0%
Not Hispanic or Latino
227
  79.1%
Unknown or Not Reported
17
   5.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 287 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  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 287 participants
United States 250
Australia 3
Canada 25
Israel 1
Mexico 1
New Zealand 2
Puerto Rico 4
Switzerland 1
1.Primary Outcome
Title Event Free Survival Without Receiving Radiation Therapy (EFSnoRT).
Hide Description Survival is defined as the minimum time from study entry to requirement for additional chemotherapy and IFRT for retrieval, occurrence of a second malignant neoplasm, or death from any cause. Patients without report of such events where censored at last contact. Patients who achieve less than CR after 3 cycles of AV-PC will require IFRT and hence will satisfy this definition at the time of response evaluation. Patients who achieve a CR but who relapse will receive addition chemotherapy and IFRT or intense retrieval and hence will satisfy this definition at the time of the first relapse of Hodgkin disease. This endpoint will be used to compute event free survival without receiving radiation therapy (EFSnoRT).
Time Frame At 60 months
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible (n=278) and evaluable response and review of response, n=275. Follow-up for censored patients (n=138) is 76 months (range: 1.8 to 108 months).
Arm/Group Title Group 1
Hide Arm/Group Description:
Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim
Overall Number of Participants Analyzed 275
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Probability of survival
0.49
(0.42 to 0.54)
2.Primary Outcome
Title Intensive Therapy Free Survival (ITFS).
Hide Description Survival is defined as the minimum time from study entry to a relapse of higher risk at any time, any relapse following treatment with protocol mandated IFRT, death from any cause, or the occurrence of a second malignant neoplasm. This will be used to compute intensive therapy free survival (ITFS). Patients without report of such events where censored at last contact. This differs from traditional EFS in that relapse after AVPC* x3 therapy alone that does not place the patient in a higher risk category is not considered a treatment failure. In this definition, higher-risk relapse refers to relapse involving sites and extent of disease that place the patient in the current COG definition of intermediate or high-risk disease. If a patient with CR who experiences a LR relapse is not retreated with protocol-mandated chemotherapy and IFRT, subsequent disease relapses will nevertheless be counted in the analysis of the treatment strategy.
Time Frame At 60 months
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible (n=278) and evaluable response and review of response, n=275. Follow-up for censored patients (n=245) is 76 months (range: 4.7 to 109 months).
Arm/Group Title Group 1
Hide Arm/Group Description:
Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim
Overall Number of Participants Analyzed 275
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Probability of survival
0.89
(0.84 to 0.92)
3.Primary Outcome
Title Event Free Survival (EFS)
Hide Description Survival is defined as the minimum time from study entry to a relapse of any kind, death from any cause, or occurrence of a second malignant neoplasm. Patients without report of such events where censored at last contact. This will be used to compute event free survival (EFS).
Time Frame At 60 months
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible (n=278). Follow-up for censored patients (n=223) is 75 months (range: 4.7 to 108 months).
Arm/Group Title Group 1
Hide Arm/Group Description:
Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim
Overall Number of Participants Analyzed 278
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Probability of survival
0.79
(0.74 to 0.84)
4.Secondary Outcome
Title Overall Survival
Hide Description Survival is defined as time from study entry to death due to any cause. Patients alive at last contact where censored at last contact.
Time Frame At 60 months
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible (n=278). Follow-up for censored patients (n=277) is 76 months (range: 4.7 to 109 months).
Arm/Group Title Group 1
Hide Arm/Group Description:
Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim
Overall Number of Participants Analyzed 278
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Probability of survival
0.99
(0.97 to 1.00)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim
Hide Arm/Group Description

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

All-Cause Mortality
Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim
Affected / at Risk (%) # Events
Total   2/278 (0.72%)    
Infections and infestations   
Infections and infestations - Other, specify  1/278 (0.36%)  1
Investigations   
CPK increased  1/278 (0.36%)  1
Metabolism and nutrition disorders   
Acidosis  1/278 (0.36%)  1
Vascular disorders   
Thromboembolic event  1/278 (0.36%)  1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim
Affected / at Risk (%) # Events
Total   80/278 (28.78%)    
Blood and lymphatic system disorders   
Febrile neutropenia  18/278 (6.47%)  18
Ear and labyrinth disorders   
Hearing impaired  2/278 (0.72%)  2
Tinnitus  2/278 (0.72%)  2
Endocrine disorders   
Delayed puberty  1/278 (0.36%)  1
Hypothyroidism  1/278 (0.36%)  1
Eye disorders   
Eye pain  1/278 (0.36%)  1
Optic nerve disorder  1/278 (0.36%)  1
Gastrointestinal disorders   
Abdominal pain  3/278 (1.08%)  3
Constipation  3/278 (1.08%)  3
Enterocolitis  1/278 (0.36%)  1
Esophageal pain  1/278 (0.36%)  1
Esophagitis  1/278 (0.36%)  1
Ileus  2/278 (0.72%)  2
Mucositis oral  4/278 (1.44%)  4
Nausea  10/278 (3.60%)  10
Oral pain  2/278 (0.72%)  2
Vomiting  10/278 (3.60%)  10
General disorders   
Fatigue  4/278 (1.44%)  4
Pain  2/278 (0.72%)  2
Immune system disorders   
Anaphylaxis  1/278 (0.36%)  1
Infections and infestations   
Bladder infection  1/278 (0.36%)  1
Catheter related infection  2/278 (0.72%)  2
Infections and infestations - Other, specify  12/278 (4.32%)  12
Lung infection  1/278 (0.36%)  1
Skin infection  1/278 (0.36%)  1
Soft tissue infection  1/278 (0.36%)  1
Tracheitis  1/278 (0.36%)  1
Upper respiratory infection  2/278 (0.72%)  2
Injury, poisoning and procedural complications   
Vascular access complication  4/278 (1.44%)  4
Investigations   
Alanine aminotransferase increased  2/278 (0.72%)  2
Aspartate aminotransferase increased  2/278 (0.72%)  2
Lymphocyte count decreased  1/278 (0.36%)  1
Neutrophil count decreased  7/278 (2.52%)  7
Platelet count decreased  1/278 (0.36%)  1
White blood cell decreased  6/278 (2.16%)  6
Metabolism and nutrition disorders   
Hyperglycemia  3/278 (1.08%)  3
Hyperkalemia  1/278 (0.36%)  1
Hypermagnesemia  1/278 (0.36%)  1
Hypokalemia  7/278 (2.52%)  7
Hyponatremia  1/278 (0.36%)  1
Hypophosphatemia  3/278 (1.08%)  3
Musculoskeletal and connective tissue disorders   
Arthralgia  1/278 (0.36%)  1
Bone pain  2/278 (0.72%)  2
Generalized muscle weakness  1/278 (0.36%)  1
Myalgia  3/278 (1.08%)  3
Nervous system disorders   
Headache  3/278 (1.08%)  3
Neuralgia  4/278 (1.44%)  4
Peripheral motor neuropathy  2/278 (0.72%)  2
Peripheral sensory neuropathy  1/278 (0.36%)  1
Syncope  2/278 (0.72%)  2
Vasovagal reaction  1/278 (0.36%)  1
Psychiatric disorders   
Agitation  1/278 (0.36%)  1
Anxiety  1/278 (0.36%)  1
Depression  1/278 (0.36%)  1
Insomnia  2/278 (0.72%)  2
Respiratory, thoracic and mediastinal disorders   
Bronchospasm  1/278 (0.36%)  1
Pharyngeal mucositis  1/278 (0.36%)  1
Pharyngolaryngeal pain  1/278 (0.36%)  1
Skin and subcutaneous tissue disorders   
Rash maculo-papular  1/278 (0.36%)  1
Vascular disorders   
Hypotension  2/278 (0.72%)  2
Thromboembolic event  2/278 (0.72%)  2
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.
Must obtain prior Sponsor approval.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Results Reporting Coordinator
Organization: Children's Oncology Group
Phone: 626-447-0064
EMail: resultsreportingcoordinator@childrensoncologygroup.org
Layout table for additonal information
Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00302003    
Other Study ID Numbers: AHOD0431
NCI-2009-00377 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000459962 ( Other Identifier: Clinical Trials.gov )
U10CA098543 ( U.S. NIH Grant/Contract )
COG-AHOD0431 ( Other Identifier: Children's Oncology Group )
First Submitted: March 9, 2006
First Posted: March 13, 2006
Results First Submitted: June 29, 2016
Results First Posted: February 9, 2017
Last Update Posted: March 30, 2021