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Combination Chemotherapy With or Without Radiation Therapy in Treating Young Patients With Favorable-Risk Hodgkin Lymphoma

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ClinicalTrials.gov Identifier: NCT00846742
Recruitment Status : Active, not recruiting
First Posted : February 19, 2009
Results First Posted : February 10, 2020
Last Update Posted : February 24, 2020
Sponsor:
Information provided by (Responsible Party):
St. Jude Children's Research Hospital

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hodgkin Lymphoma
Interventions Drug: Stanford V Chemotherapy
Radiation: Radiation Therapy
Enrollment 88
Recruitment Details 88 participants were enrolled from 5 institutions between June 2009 and October 2018.
Pre-assignment Details Two out of 88 enrolled patients are ineligible and were removed from the study. They were determined to be intermediate risk rather than low risk. One was taken off study after being re-consented on an expired consent and treated with cyclophosphamide instead of mechlorethamine; 1 patient withdrew from study but was evaluable for primary objective.
Arm/Group Title Stanford V Chemotherapy
Hide Arm/Group Description

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
Period Title: Overall Study
Started 85
With Radiation Therapy (RT) [1] 17
Without Radiation Therapy (RT) [2] 68
Completed 84
Not Completed 1
Reason Not Completed
Withdrawal by Subject             1
[1]
Seventeen (17) participants out of the 85 analyzed received radiation therapy (RT)
[2]
Sixty-eight (68) participants out of the 85 analyzed did not receive RT
Arm/Group Title Stanford V Chemotherapy
Hide Arm/Group Description

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
Overall Number of Baseline Participants 85
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 85 participants
13.6  (4.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 85 participants
Female
33
  38.8%
Male
52
  61.2%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 85 participants
White
66
  77.6%
Black
8
   9.4%
Asian
3
   3.5%
Multiple Race (NOS)
3
   3.5%
Other
3
   3.5%
American Ind / Alaskan / White
1
   1.2%
Asian and White
1
   1.2%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 85 participants
St. Jude Children's Research Hospital
46
  54.1%
Stanford University Medical Center
15
  17.6%
Dana Farber Cancer Institute
13
  15.3%
Rady Children's Hospital San Diego
6
   7.1%
Maine Medical Center
5
   5.9%
Stage: IA, IIA   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 85 participants
IA
29
  34.1%
IIA
56
  65.9%
[1]
Measure Description: Stages were according to the Ann Arbor Classification (stage I: one single lymph node group involved, stage II: 2 lymph node groups involved on one side of the diaphragm). “A” stands for absence of “B” symptoms (fevers, night sweats or weight loss).
1.Primary Outcome
Title Complete Response Rate Estimate
Hide Description To increase the complete response rate of favorable risk patients (excluding all patients with stage IA nodular lymphocyte predominant Hodgkin lymphoma) after 8 weeks Stanford V by at least 20% compared to favorable risk patients on HOD 99 after 8 weeks VAMP (NCT number: NCT00145600) .Complete response definition: Disappearance of all measurable or evaluable disease, signs, symptoms and biochemical changes related to the tumor. Biopsy confirmation is not mandatory. Residual PET-negative CT scan abnormalities representing > 75% reduction (as measured by the product of 2 perpendicular diameters of lesions by CT or MR imaging) in the original tumor volume will be considered scar tissue without active tumor.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Stanford V Chemotherapy
Hide Arm/Group Description:
Non-stage IA non-LP favorable risk participants receive 8 weeks of Stanford V chemotherapy.
Overall Number of Participants Analyzed 56
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
77
(64 to 87)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Stanford V Chemotherapy
Comments The proportion of patients’ complete response rate was provided with a 95% confidence interval.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments Comparison of proportion of patients’ complete response rate between HOD99 (NCT number: NCT00145600) and HOD08
Method Exact Binominal Test
Comments [Not Specified]
2.Secondary Outcome
Title Disease Failure Rate Within Radiation Fields
Hide Description Defined as disease that recurs in the initially involved nodal region within the field of irradiation. The disease failure rate within the radiation fields will be estimated with a 95% confidence interval using appropriate methods (e.g., estimate cumulative incidence in the presence of competing risks).
Time Frame median 2 year post therapy
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Treatment Failure Patterns for Children Treated With Tailored-field Radiation
Hide Description Descriptive statistics related to local/distant failure will be produced. The cumulative incidence of local failure will be estimated and effects of prognostic factors will be examined. Effect of competing risks (distant failure, second malignancy and death) will be taken into account. Relapse rate within the radiation fields will be estimated and confidence interval will also be calculated.
Time Frame median 2 years post therapy
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Acute Hematologic Toxicities
Hide Description Description of acute hematologic toxicities as they relate to transfusion requirements, growth factor support, episodes of febrile neutropenia and hospitalizations, according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. The acute hematologic toxicities were summarized descriptively.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Stanford V Chemotherapy
Hide Arm/Group Description:

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
Overall Number of Participants Analyzed 85
Measure Type: Number
Unit of Measure: adverse events
Neutrophils/granulocytes (ANC/AGC) 64
Leukocytes (total WBC) 74
Lymphopenia 54
Hemoglobin 14
Platelets 1
5.Secondary Outcome
Title Acute Infectious Toxicities
Hide Description Description of acute infectious toxicities as they relate to transfusion requirements, growth factor support, episodes of febrile neutropenia and hospitalizations, according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. The acute infectious toxicities were summarized descriptively.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Stanford V Chemotherapy
Hide Arm/Group Description:

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
Overall Number of Participants Analyzed 85
Measure Type: Number
Unit of Measure: Adverse events
Febrile neutropenia 8
Infection, Blood 2
Infection, Upper Airway NOS 1
6.Secondary Outcome
Title Comparison of Event-free and Overall Survival Distributions, Cumulative Incidence of Local Failure, and Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99
Hide Description Log-rank tests used to compare event-free survival and overall survival. Event-free survival is defined as time interval from the date of study enrollment to the date of first event (relapsed or progressive disease, second malignancy, or death from any cause) or to last follow-up for patients without events. Survival is defined as time interval from study enrollment to date of death from any cause or to date of last follow-up. Gray's test used to compare cumulative incidence of local failure between favorable risk patients treated on this protocol vs. treated on HOD99 and other regimens.
Time Frame median 2 years post therapy
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Comparison of Event-free Survival Distributions Between Patients That Will Not be Prescribed Radiotherapy After 8 Weeks Stanford V and Those Patients on HOD99 That Received VAMP Without Radiotherapy
Hide Description Log-rank tests used to compare event-free survival and overall survival. Event-free survival is defined as time interval from the date of study enrollment to the date of first event (relapsed or progressive disease, second malignancy, or death from any cause) or to last follow-up for patients without events. Survival is defined as time interval from study enrollment to date of death from any cause or to date of last follow-up. Gray's test used to compare cumulative incidence of local failure between favorable risk patients treated on this protocol vs. treated on HOD99 and other regimens.
Time Frame median 2 years post therapy
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Event-free Survival Distributions of Favorable Risk Patients Treated With Stanford V Chemotherapy Alone and Patients Treated With Stanford V Chemotherapy Plus Low Dose Tailored-field Radiation
Hide Description Event-free survival distributions of favorable risk patients treated with Stanford V chemotherapy alone and patients treated with Stanford V chemotherapy plus low dose tailored field radiation will be estimated by the Kaplan-Meier method.
Time Frame median 2 years post therapy
Outcome Measure Data Not Reported
Time Frame Acute adverse events were collected from study enrollment up to 4 weeks after completion of chemotherapy/radiation therapy, whichever came last. Long term toxicity was captured at every visit up to 5 years from study enrollment.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Stanford V Chemotherapy
Hide Arm/Group Description

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
All-Cause Mortality
Stanford V Chemotherapy
Affected / at Risk (%)
Total   1/85 (1.18%)    
Hide Serious Adverse Events
Stanford V Chemotherapy
Affected / at Risk (%) # Events
Total   1/85 (1.18%)    
Blood and lymphatic system disorders   
Leukocytes (total WBC) * 1  1/85 (1.18%)  1
Neutrophils/granulocytes (ANC/AGC) * 1  1/85 (1.18%)  1
1
Term from vocabulary, CTCAE 3.0
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Stanford V Chemotherapy
Affected / at Risk (%) # Events
Total   58/85 (68.24%)    
Blood and lymphatic system disorders   
Neutrophils/granulocytes (ANC/AGC) * 1  39/85 (45.88%)  63
Leukocytes (total WBC) * 1  36/85 (42.35%)  73
Lymphopenia * 1  22/85 (25.88%)  54
Hemoglobin * 1  9/85 (10.59%)  14
Infections and infestations   
Febrile neutropenia * 1 [1]  6/85 (7.06%)  8
1
Term from vocabulary, CTCAE 3.0
*
Indicates events were collected by non-systematic assessment
[1]
Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infection)(ANC <1.0 x 10e9/L, fever ≥38.5°C)
During a mechlorethamine shortage cyclophosphamide was administered instead leading to inferior outcome in intermediate and high risk patients. These patients were replaced in this protocol. The study was closed early after our new protocol opened.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Monika Metzger, MD
Organization: St. Jude Children's Research Hospital
Phone: (901) 595-4974
EMail: monika.metzger@stjude.org
Layout table for additonal information
Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT00846742    
Other Study ID Numbers: HOD08
NCI-2009-01138 ( Registry Identifier: NCI's Clinical Trial Reporting Program )
First Submitted: February 17, 2009
First Posted: February 19, 2009
Results First Submitted: January 8, 2020
Results First Posted: February 10, 2020
Last Update Posted: February 24, 2020