Trial Outcomes & Findings for Combination Chemotherapy With or Without Radiation Therapy in Treating Young Patients With Favorable-Risk Hodgkin Lymphoma (NCT NCT00846742)

NCT ID: NCT00846742

Last Updated: 2025-12-08

Results Overview

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.

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE2
• Target enrollment: 88 participants
• Primary outcome timeframe: 8 weeks
• Results posted on: 2025-12-08

Participant Flow

88 participants were enrolled from 5 institutions between June 2009 and October 2018.

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.

Participant milestones

Measure	Stanford V Chemotherapy 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 Study STARTED	85
Overall Study With Radiation Therapy (RT)	17
Overall Study Without Radiation Therapy (RT)	68
Overall Study COMPLETED	84
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Stanford V Chemotherapy 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 Study Withdrawal by Subject	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Stanford V Chemotherapy n=85 Participants 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
Age, Continuous	13.6 years STANDARD_DEVIATION 4.5 • n=37 Participants
Sex: Female, Male Female	33 Participants n=37 Participants
Sex: Female, Male Male	52 Participants n=37 Participants
Race/Ethnicity, Customized Race · White	66 Participants n=37 Participants
Race/Ethnicity, Customized Race · Black	8 Participants n=37 Participants
Race/Ethnicity, Customized Race · Asian	3 Participants n=37 Participants
Race/Ethnicity, Customized Race · Multiple Race (NOS)	3 Participants n=37 Participants
Race/Ethnicity, Customized Race · Other	3 Participants n=37 Participants
Race/Ethnicity, Customized Race · American Ind / Alaskan / White	1 Participants n=37 Participants
Race/Ethnicity, Customized Race · Asian and White	1 Participants n=37 Participants
Region of Enrollment United States · St. Jude Children's Research Hospital	46 Participants n=37 Participants
Region of Enrollment United States · Stanford University Medical Center	15 Participants n=37 Participants
Region of Enrollment United States · Dana Farber Cancer Institute	13 Participants n=37 Participants
Region of Enrollment United States · Rady Children's Hospital San Diego	6 Participants n=37 Participants
Region of Enrollment United States · Maine Medical Center	5 Participants n=37 Participants
Stage: IA, IIA IA	29 Participants n=37 Participants
Stage: IA, IIA IIA	56 Participants n=37 Participants

PRIMARY outcome

Timeframe: 8 weeks

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.

Outcome measures

Measure	Stanford V Chemotherapy n=56 Participants Non-stage IA non-LP favorable risk participants receive 8 weeks of Stanford V chemotherapy.	HOD99 Participants Favorable Risk participants treated on the earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD08 - Grade 5 Participants in current study.	HOD99 - Grade 3 Favorable Risk participants treated on the earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 4 Favorable Risk participants treated on the earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 5 Favorable Risk participants treated on the earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
Complete Response Rate Estimate	77 percentage of participants Interval 64.0 to 87.0	—	—	—	—	—

SECONDARY outcome

Timeframe: 6 months

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.

Outcome measures

Measure	Stanford V Chemotherapy n=85 Participants Non-stage IA non-LP favorable risk participants receive 8 weeks of Stanford V chemotherapy.	HOD99 Participants Favorable Risk participants treated on the earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD08 - Grade 5 Participants in current study.	HOD99 - Grade 3 Favorable Risk participants treated on the earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 4 Favorable Risk participants treated on the earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 5 Favorable Risk participants treated on the earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
Acute Hematologic Toxicities Hemoglobin	14 adverse events	—	—	—	—	—
Acute Hematologic Toxicities Platelets	1 adverse events	—	—	—	—	—
Acute Hematologic Toxicities Neutrophils/granulocytes (ANC/AGC)	64 adverse events	—	—	—	—	—
Acute Hematologic Toxicities Leukocytes (total WBC)	74 adverse events	—	—	—	—	—
Acute Hematologic Toxicities Lymphopenia	54 adverse events	—	—	—	—	—

SECONDARY outcome

Timeframe: 6 months

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.

Outcome measures

Measure	Stanford V Chemotherapy n=85 Participants Non-stage IA non-LP favorable risk participants receive 8 weeks of Stanford V chemotherapy.	HOD99 Participants Favorable Risk participants treated on the earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD08 - Grade 5 Participants in current study.	HOD99 - Grade 3 Favorable Risk participants treated on the earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 4 Favorable Risk participants treated on the earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 5 Favorable Risk participants treated on the earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
Acute Infectious Toxicities Febrile neutropenia	8 Adverse events	—	—	—	—	—
Acute Infectious Toxicities Infection, Blood	2 Adverse events	—	—	—	—	—
Acute Infectious Toxicities Infection, Upper Airway NOS	1 Adverse events	—	—	—	—	—

SECONDARY outcome

Timeframe: median 2 year post therapy

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).

Outcome measures

Measure	Stanford V Chemotherapy n=17 Participants Non-stage IA non-LP favorable risk participants receive 8 weeks of Stanford V chemotherapy.	HOD99 Participants Favorable Risk participants treated on the earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD08 - Grade 5 Participants in current study.	HOD99 - Grade 3 Favorable Risk participants treated on the earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 4 Favorable Risk participants treated on the earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 5 Favorable Risk participants treated on the earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
Disease Failure Rate Within Radiation Fields	0.059 probability that the event occurs Interval 0.003 to 0.242	—	—	—	—	—

SECONDARY outcome

Timeframe: median 2 years post therapy

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.

Outcome measures

Measure	Stanford V Chemotherapy n=17 Participants Non-stage IA non-LP favorable risk participants receive 8 weeks of Stanford V chemotherapy.	HOD99 Participants Favorable Risk participants treated on the earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD08 - Grade 5 Participants in current study.	HOD99 - Grade 3 Favorable Risk participants treated on the earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 4 Favorable Risk participants treated on the earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 5 Favorable Risk participants treated on the earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
Treatment Failure Patterns for Children Treated With Tailored-field Radiation 2-year Cumulative incidence of distant failure	0.000 probability that the event occurs Interval 0.0 to 0.0	—	—	—	—	—
Treatment Failure Patterns for Children Treated With Tailored-field Radiation 2-year Cumulative incidence of local failure	0.059 probability that the event occurs Interval 0.003 to 0.242	—	—	—	—	—

SECONDARY outcome

Timeframe: median 2 years post therapy

Age was examined for the association with cumulative incidence of local failure. Effect of competing risks (distant failure, second malignancy and death) will be taken into account. Fine and Gray's competing risk regression model with Wald test will be used to compute the p value for the statistical significance.

Outcome measures

Measure	Stanford V Chemotherapy n=17 Participants Non-stage IA non-LP favorable risk participants receive 8 weeks of Stanford V chemotherapy.	HOD99 Participants Favorable Risk participants treated on the earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD08 - Grade 5 Participants in current study.	HOD99 - Grade 3 Favorable Risk participants treated on the earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 4 Favorable Risk participants treated on the earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 5 Favorable Risk participants treated on the earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
Prognostic Factors for Local Failure in Children Treated With Tailored-Field Radiation: Age	0.969 hazard ratio Interval 0.81 to 1.159	—	—	—	—	—

SECONDARY outcome

Timeframe: median 2 years post therapy

Gender was examined for the association with cumulative incidence of local failure. Effect of competing risks (distant failure, second malignancy and death) will be taken into account. Fine and Gray's competing risk regression model with Wald test will be used to compute the p value for the statistical significance.

Outcome measures

Measure	Stanford V Chemotherapy n=17 Participants Non-stage IA non-LP favorable risk participants receive 8 weeks of Stanford V chemotherapy.	HOD99 Participants Favorable Risk participants treated on the earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD08 - Grade 5 Participants in current study.	HOD99 - Grade 3 Favorable Risk participants treated on the earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 4 Favorable Risk participants treated on the earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 5 Favorable Risk participants treated on the earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
Prognostic Factors for Local Failure in Children Treated With Tailored-Field Radiation: Gender	0.000 hazard ratio Interval 0.0 to 0.0	—	—	—	—	—

SECONDARY outcome

Timeframe: median 2 years post therapy

Stage was examined for the association with cumulative incidence of local failure. Effect of competing risks (distant failure, second malignancy and death) will be taken into account. Fine and Gray's competing risk regression model with Wald test will be used to compute the p value for the statistical significance.

Outcome measures

Measure	Stanford V Chemotherapy n=17 Participants Non-stage IA non-LP favorable risk participants receive 8 weeks of Stanford V chemotherapy.	HOD99 Participants Favorable Risk participants treated on the earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD08 - Grade 5 Participants in current study.	HOD99 - Grade 3 Favorable Risk participants treated on the earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 4 Favorable Risk participants treated on the earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 5 Favorable Risk participants treated on the earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
Prognostic Factors for Local Failure in Children Treated With Tailored-Field Radiation: Stage	30101.410 hazard ratio Interval 3329.573 to 272135.5	—	—	—	—	—

SECONDARY outcome

Timeframe: median 2 years post therapy

Histology was examined for its association with the cumulative incidence of local failure. Effect of competing risks (distant failure, second malignancy and death) will be taken into account. Fine and Gray's competing risk regression model with the Wald test will be used to compute the p-value for statistical significance.

Outcome measures

Measure	Stanford V Chemotherapy n=17 Participants Non-stage IA non-LP favorable risk participants receive 8 weeks of Stanford V chemotherapy.	HOD99 Participants Favorable Risk participants treated on the earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD08 - Grade 5 Participants in current study.	HOD99 - Grade 3 Favorable Risk participants treated on the earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 4 Favorable Risk participants treated on the earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 5 Favorable Risk participants treated on the earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
Prognostic Factors for Local Failure in Children Treated With Tailored-Field Radiation: Histology	34027.680 hazard ratio Interval 4072.872 to 284291.6	—	—	—	—	—

SECONDARY outcome

Timeframe: median 2 years post therapy

Log-rank tests are 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.

Outcome measures

Measure	Stanford V Chemotherapy n=85 Participants Non-stage IA non-LP favorable risk participants receive 8 weeks of Stanford V chemotherapy.	HOD99 Participants n=88 Participants Favorable Risk participants treated on the earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD08 - Grade 5 Participants in current study.	HOD99 - Grade 3 Favorable Risk participants treated on the earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 4 Favorable Risk participants treated on the earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 5 Favorable Risk participants treated on the earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
Comparison of Event-free and Overall Survival Distributions, and Cumulative Incidence of Local Failure of Patients Treated on This Study to Outcome in the Favorable Risk Group of HOD99 2-year Event-free Survival (EFS) Probability	0.939 probability Interval 0.889 to 0.992	0.909 probability Interval 0.851 to 0.971	—	—	—	—
Comparison of Event-free and Overall Survival Distributions, and Cumulative Incidence of Local Failure of Patients Treated on This Study to Outcome in the Favorable Risk Group of HOD99 2-year Overall Survival (OS) Probability	1.000 probability Interval 1.0 to 1.0	1.000 probability Interval 1.0 to 1.0	—	—	—	—
Comparison of Event-free and Overall Survival Distributions, and Cumulative Incidence of Local Failure of Patients Treated on This Study to Outcome in the Favorable Risk Group of HOD99 2-year Cumulative Incidence (CI) of Local Failure	0.061 probability Interval 0.022 to 0.127	0.068 probability Interval 0.028 to 0.134	—	—	—	—

SECONDARY outcome

Timeframe: median 2 years post therapy

Population: Additional description can be found here for the following Row Titles: Febrile neutropenia - (fever of unknown origin without clinically or microbiologically documented infection)(ANC \<1.0 x 10e9/L, fever \>=38.5 degrees C) Infection, Blood - (documented clinically or microbiologically documented infection) (ANC\<1.0x10\^9/L, fever \> 38.5C) Infection, Paranasal - (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)

Comparison of the toxicities with grade > 2 of low-risk patients treated with reduced duration Stanford V chemotherapy with or without low-dose tailored-field radiation (current HOD08 protocol) to those of favorable-risk patients on HOD99 (NCT00145600). Grading of toxicities for HOD08 and HOD99 used the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.

Outcome measures

Measure	Stanford V Chemotherapy n=85 Participants Non-stage IA non-LP favorable risk participants receive 8 weeks of Stanford V chemotherapy.	HOD99 Participants n=85 Participants Favorable Risk participants treated on the earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD08 - Grade 5 n=85 Participants Participants in current study.	HOD99 - Grade 3 n=88 Participants Favorable Risk participants treated on the earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 4 n=88 Participants Favorable Risk participants treated on the earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 5 n=88 Participants Favorable Risk participants treated on the earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)	0 adverse events	0 adverse events	0 adverse events	2 adverse events	0 adverse events	0 adverse events
Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 ALT, SGPT (serum glutamic pyruvic transaminase)	0 adverse events	0 adverse events	0 adverse events	2 adverse events	0 adverse events	0 adverse events
Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 AST, SGOT(serum glutamic oxaloacetic transaminase)	0 adverse events	0 adverse events	0 adverse events	2 adverse events	0 adverse events	0 adverse events
Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 Bicarbonate, serum-low	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events
Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 Blood/Bone Marrow - Other (Specify, __)	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events
Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 Calcium, serum-low (hypocalcemia)	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events
Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 Constipation	1 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events
Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 Dehydration	1 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events
Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 Febrile neutropenia	4 adverse events	2 adverse events	0 adverse events	1 adverse events	1 adverse events	0 adverse events
Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 Flu-like syndrome	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events
Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 Gastritis (including bile reflux gastritis)	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events
Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 Glucose, serum-high (hyperglycemia)	0 adverse events	0 adverse events	0 adverse events	1 adverse events	1 adverse events	0 adverse events
Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 Hemoglobin	6 adverse events	2 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events
Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 Hypotension	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events
Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 Hypoxia	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events
Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 Infection, Blood	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events
Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 Infection, Paranasal	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events
Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 Infection with normal ANC or Grade 1 or 2 neutrophils, Blood	2 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events
Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 Infection with normal ANC or Grade 1 or 2 neutrophils, Catheter-related	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events
Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 Infection with normal ANC or Grade 1 or 2 neutrophils, Pharynx	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events
Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 Infection with normal ANC or Grade 1 or 2 neutrophils, Skin (cellulitis)	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events
Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 Infection with normal ANC or Grade 1 or 2 neutrophils, Upper airway NOS	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events
Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 Infection with normal ANC or Grade 1 or 2 neutrophils, Urinary tract NOS	1 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events
Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 Infection with unknown ANC, Lung (pneumonia)	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events
Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 Insomnia	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events
Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 Leukocytes (total WBC)	34 adverse events	18 adverse events	0 adverse events	23 adverse events	0 adverse events	0 adverse events
Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 Lymphopenia	23 adverse events	10 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events
Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 Magnesium, serum-high (hypermagnesemia)	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events
Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 Magnesium, serum-low (hypomagnesemia)	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events
Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 Nausea	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events
Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 Mood alteration, Depression	0 adverse events	0 adverse events	0 adverse events	3 adverse events	0 adverse events	0 adverse events
Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 Neuropathy: sensory	0 adverse events	0 adverse events	0 adverse events	4 adverse events	0 adverse events	0 adverse events
Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 Neutrophils/granulocytes (ANC/AGC)	32 adverse events	25 adverse events	0 adverse events	36 adverse events	51 adverse events	0 adverse events
Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 Obstruction, GU, Bladder	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events
Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 Pain - Other (Specify, __)	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events
Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 Pain, Joint	0 adverse events	0 adverse events	0 adverse events	2 adverse events	0 adverse events	0 adverse events
Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 Pain, Abdomen NOS	2 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events
Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 Pain, Bone	0 adverse events	0 adverse events	0 adverse events	1 adverse events	1 adverse events	0 adverse events
Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 Pain, Chest/thorax NOS	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events
Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 Pain, Extremity-limb	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events
Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 Pain, Neuralgia/peripheral nerve	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events
Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 Personality/behavioral	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events
Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 Phosphate, serum-low (hypophosphatemia)	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events
Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 Potassium, serum-high (hyperkalemia)	0 adverse events	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events
Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 Potassium, serum-low (hypokalemia)	0 adverse events	0 adverse events	0 adverse events	1 adverse events	1 adverse events	0 adverse events
Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 Renal failure	1 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events	0 adverse events
Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 Sodium, serum-low (hyponatremia)	0 adverse events	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events
Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 Thrombosis/embolism (vascular access-related)	0 adverse events	0 adverse events	0 adverse events	2 adverse events	0 adverse events	0 adverse events
Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 Thrombosis/thrombus/embolism	1 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events
Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 Vomiting	2 adverse events	0 adverse events	0 adverse events	3 adverse events	0 adverse events	0 adverse events
Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 Weight gain	0 adverse events	0 adverse events	0 adverse events	1 adverse events	0 adverse events	0 adverse events

SECONDARY outcome

Timeframe: median 2 years post therapy

Population: HOD08 - CR: Participants who achieved CR after chemotherapy and were not prescribed RT. Two patients without RT were excluded: 1 was prescribed but did not receive it due to consent withdrawal, and 1 withdrew with no response results. HOD99 - CR: Favorable Risk participants from NCT00145600 (HOD99) who achieved CR after chemotherapy and were not prescribed RT. Two patients prescribed RT but not receiving it were excluded: 1 due to progressive disease and 1 due to consent withdrawal.

Log-rank tests are 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. Patients who will not be prescribed Radiotherapy in both protocols are those who achieved CR on the response assessment after chemotherapy.

Outcome measures

Measure	Stanford V Chemotherapy n=66 Participants Non-stage IA non-LP favorable risk participants receive 8 weeks of Stanford V chemotherapy.	HOD99 Participants n=47 Participants Favorable Risk participants treated on the earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD08 - Grade 5 Participants in current study.	HOD99 - Grade 3 Favorable Risk participants treated on the earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 4 Favorable Risk participants treated on the earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 5 Favorable Risk participants treated on the earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
Comparison of Event-free and Overall Survival Distributions and Cumulative Incidence of Local Failure Between Patients That Will Not be Prescribed Radiotherapy After 8 Weeks Stanford V and Those Patients on HOD99 That Received VAMP Without Radiotherapy 2-year Event-free Survival (EFS) Probability	0.938 probability Interval 0.881 to 0.999	0.894 probability Interval 0.81 to 0.986	—	—	—	—
Comparison of Event-free and Overall Survival Distributions and Cumulative Incidence of Local Failure Between Patients That Will Not be Prescribed Radiotherapy After 8 Weeks Stanford V and Those Patients on HOD99 That Received VAMP Without Radiotherapy 2-year Overall Survival (OS) Probability	1.000 probability Interval 1.0 to 1.0	1.000 probability Interval 1.0 to 1.0	—	—	—	—
Comparison of Event-free and Overall Survival Distributions and Cumulative Incidence of Local Failure Between Patients That Will Not be Prescribed Radiotherapy After 8 Weeks Stanford V and Those Patients on HOD99 That Received VAMP Without Radiotherapy 2-year Cumulative Incidence (CI) of Local Failure	0.062 probability Interval 0.02 to 0.139	0.106 probability Interval 0.039 to 0.214	—	—	—	—

SECONDARY outcome

Timeframe: median 2 years post therapy

Population: Stanford V Chemotherapy Alone: Out of the 68 patients treated with Stanford V chemotherapy alone, without low-dose tailored-field radiation: 66 patients were not prescribed radiotherapy as they achieved a Complete Response (CR) on the Response Assessment after chemotherapy. One patient didn't achieve a CR but withdrew from the study before receiving radiotherapy. One patient had a missing response result and withdrew from the study without undergoing radiotherapy.

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.

Outcome measures

Measure	Stanford V Chemotherapy n=68 Participants Non-stage IA non-LP favorable risk participants receive 8 weeks of Stanford V chemotherapy.	HOD99 Participants n=17 Participants Favorable Risk participants treated on the earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD08 - Grade 5 Participants in current study.	HOD99 - Grade 3 Favorable Risk participants treated on the earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 4 Favorable Risk participants treated on the earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.	HOD99 - Grade 5 Favorable Risk participants treated on the earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
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	0.939 probability of event free survival Interval 0.882 to 0.999	0.941 probability of event free survival Interval 0.836 to 1.0	—	—	—	—

Adverse Events

Stanford V Chemotherapy

Serious events: 1 serious events

Other events: 58 other events

Deaths: 1 deaths

Serious adverse events

Measure	Stanford V Chemotherapy n=85 participants at 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
Blood and lymphatic system disorders Leukocytes (total WBC)	1.2% 1/85 • Number of events 1 • 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.
Blood and lymphatic system disorders Neutrophils/granulocytes (ANC/AGC)	1.2% 1/85 • Number of events 1 • 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.

Other adverse events

Measure	Stanford V Chemotherapy n=85 participants at 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
Blood and lymphatic system disorders Neutrophils/granulocytes (ANC/AGC)	45.9% 39/85 • Number of events 63 • 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.
Blood and lymphatic system disorders Leukocytes (total WBC)	42.4% 36/85 • Number of events 73 • 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.
Blood and lymphatic system disorders Lymphopenia	25.9% 22/85 • Number of events 54 • 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.
Blood and lymphatic system disorders Hemoglobin	10.6% 9/85 • Number of events 14 • 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.
Infections and infestations Febrile neutropenia	7.1% 6/85 • Number of events 8 • 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.

Additional Information

Matt Ehrhardt, MD, MS

St. Jude Children's Research Hospital

Phone: (901) 595-5913

Email: matt.ehrhardt@stjude.org

Results disclosure agreements

• Principal investigator is a sponsor employee MSA states Site is unable to publish until all completed case report forms have been delivered to Sponsor, (Study Completion). Site shall have the right to publish after publication of a multi-center publication coordinated by the Sponsor or (12) mths. after Study Completion; provided, that prior to any such publication or public release of such data, Site shall furnish Sponsor with a copy of any proposed publication at least (45)days in advance of the proposed publication or presentation date.
• Publication restrictions are in place

Restriction type: OTHER