Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00025259
Registration number
NCT00025259
Ethics application status
Date submitted
11/10/2001
Date registered
27/01/2003
Date last updated
12/04/2017
Titles & IDs
Public title
Chemotherapy With or Without Additional Chemotherapy and/or Radiation Therapy in Treating Children With Newly Diagnosed Hodgkin's Disease
Query!
Scientific title
A Phase III Groupwide Study of Dose-Intensive Response-Based Chemotherapy and Radiation Therapy for Children and Adolescents With Newly Diagnosed Intermediate Risk Hodgkin Disease
Query!
Secondary ID [1]
0
0
NCI-2011-02069
Query!
Secondary ID [2]
0
0
AHOD0031
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Childhood Lymphocyte-Depleted Classical Hodgkin Lymphoma
0
0
Query!
Childhood Mixed Cellularity Classical Hodgkin Lymphoma
0
0
Query!
Childhood Nodular Lymphocyte Predominant Hodgkin Lymphoma
0
0
Query!
Childhood Nodular Sclerosis Classical Hodgkin Lymphoma
0
0
Query!
Stage I Childhood Hodgkin Lymphoma
0
0
Query!
Stage II Childhood Hodgkin Lymphoma
0
0
Query!
Stage III Childhood Hodgkin Lymphoma
0
0
Query!
Stage IV Childhood Hodgkin Lymphoma
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Query!
Cancer
0
0
0
0
Query!
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Query!
Cancer
0
0
0
0
Query!
Hodgkin's
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Other - Bleomycin Sulfate
Treatment: Drugs - Cisplatin
Treatment: Drugs - Cyclophosphamide
Treatment: Drugs - Cytarabine
Treatment: Drugs - Dexamethasone
Treatment: Drugs - Doxorubicin Hydrochloride
Treatment: Drugs - Etoposide
Treatment: Other - Filgrastim
Treatment: Other - Involved-Field Radiation Therapy
Treatment: Drugs - Prednisone
Treatment: Drugs - Vincristine Sulfate Liposome
Experimental: Arm I (Patients off-therapy before callback-Induction only) - Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin sulfate IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, oral prednisone 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease.
Experimental: Arm II (RER with CR [ABVE-PC, IFRT]) - Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive an additional 2 courses of ABVE-PC. Patients with sustained CR undergo IFRT approximately 3 weeks after the last day of ABVE course 4.
Experimental: Arm III (RER with CR [ABVE-PC]) - Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive an additional 2 courses of ABVE-PC. Patients with sustained CR are randomized to receive no further treatment.
Experimental: Arm IV (RER with less than CR [ABVE-PC, IFRT]) - Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive an additional 2 courses of ABVE-PC. Patients with VGPR, PR or SD undergo IFRT approximately 3 weeks after the last day of ABVE-PC course 4 for 5 days a week.
Experimental: Arm V (RER with PD) - Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients with PD are taken off therapy.
Experimental: Arm VI (SER [DECA, ABVE-PC, IFRT]) - Patients receive dexamethasone IV over 15 minutes, etoposide IV over 3 hours, and cytarabine IV over 3 hours on days 1-2. Patients receive 2 drops of dexamethasone ophthalmic solution every 6 hours on days 1, 2 and 3. Patients also receive cisplatin PO or IV over 12 hours as pre-hydration followed by continuous IV over 6 hours on day 1 and G-CSF SC beginning on day 3 and continuing until blood counts recover. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients then receive 2 additional courses of ABVE-PC chemotherapy. Patients with sustained complete or partial response undergo IFRT approximately 3 weeks after the last course of chemotherapy.
Experimental: Arm VII (SER [ABVE-PC, IFRT]) - Patients receive doxorubicin IV over 10-30 minutes on days 1-2, bleomycin IV over 10-20 minutes or SC and vincristine IV on days 1 and 8, etoposide IV over 1 hour on days 1-3, prednisone PO 2 or 3 times daily on days 1-7, and cyclophosphamide IV over 1 hour on day 1. Patients receive filgrastim (G-CSF) SC beginning on day 2 and continuing until blood counts recover (G-CSF is held on day 8). Treatment repeats every 21 days for 2 courses in the absence of progressive disease. Patients receive 2 additional courses of ABVE-PC. Patients with sustained complete or partial response undergo IFRT approximately 3 weeks after the last course of chemotherapy.
Treatment: Other: Bleomycin Sulfate
Given IV or SC
Treatment: Drugs: Cisplatin
Given IV
Treatment: Drugs: Cyclophosphamide
Given IV
Treatment: Drugs: Cytarabine
Given IV
Treatment: Drugs: Dexamethasone
Given IV
Treatment: Drugs: Doxorubicin Hydrochloride
Given IV
Treatment: Drugs: Etoposide
Given IV
Treatment: Other: Filgrastim
Given SC
Treatment: Other: Involved-Field Radiation Therapy
Undergo IFRT
Treatment: Drugs: Prednisone
Given orally
Treatment: Drugs: Vincristine Sulfate Liposome
Given IV
Query!
Intervention code [1]
0
0
Treatment: Other
Query!
Intervention code [2]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Event-free Survival
Query!
Assessment method [1]
0
0
Probability of event-Free survival which is defined as the time from study entry to treatment failure (disease progression, disease recurrence, biopsy positive residual after completion of all protocol therapy), occurrence of a second malignant neoplasm, or death from any cause. Patients without report of such events where censored at last contact.
Query!
Timepoint [1]
0
0
5 years
Query!
Secondary outcome [1]
0
0
Disease Response Assessed by Modified RECIST Criteria
Query!
Assessment method [1]
0
0
Number of participants with complete response and very good partial response at the end of protocol therapy.
Query!
Timepoint [1]
0
0
Protocol therapy: the overall duration of which is: (n=1527) an average of 137.1 days, median 133.0 days, interquartile range: 101.0, 164.0 days.
Query!
Secondary outcome [2]
0
0
Grade 3 or 4 Non-hematologic Toxicity
Query!
Assessment method [2]
0
0
Occurrence of any grade 4 non-hematologic toxicity or grade 3 non-hematologic toxicity which doesn't respond to treatment within 7 days despite recommended therapy modification, or toxic death, which is any death primarily attributable to treatment. Grade 3 is defined to be severe or medically significant but not immediate life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4 refers to toxicities with life-threatening consequences; urgent intervention indicated.
Query!
Timepoint [2]
0
0
Protocol therapy: the overall duration of which is: (n=1684) an average of 137.3 days, median 133.0 days, interquartile range: 101.0, 164.0 days.
Query!
Secondary outcome [3]
0
0
Overall Survival
Query!
Assessment method [3]
0
0
Probability of overall survival which is defined as the time from study entry to death from any cause. Patients alive where censored at last contact.
Query!
Timepoint [3]
0
0
5 years
Query!
Eligibility
Key inclusion criteria
* Patients with newly diagnosed, pathologically confirmed Hodgkin disease (all histologies) are eligible for this protocol if they meet the following clinical stage guidelines:
* All Stage IB regardless of bulk disease
* All Stage IIB regardless of bulk disease
* Stage IA only with bulk disease
* Stage IIA only with bulk disease
* All Stage IAE, IIAE regardless of bulk disease
* All Stage IIIA, IIIAE, IIIAS, IIIAE+S regardless of bulk disease
* All Stage IVA, IVAE regardless of bulk disease
* May not be staged by laparotomy alone
* Surgically staged patients must also have presurgical staging
* Bilirubin no greater than 1.5 times normal
* SGOT or SGPT less than 2.5 times normal
* Creatinine no greater than 1.5 times normal
* Creatinine clearance greater than 40 mL/min
* Radioisotope glomerular filtration rate greater than 70 mL/min
* Shortening fraction at least 27% by echocardiogram
* Ejection fraction at least 50% by MUGA
* No pathologic prolongation of QTc interval on 12-lead electrocardiogram
* FEV_1/FVC greater than 60% by pulmonary function test
* Pulse oximetry greater than 94%
* No evidence of dyspnea at rest
* No exercise intolerance
* Adequate venous access
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No prior chemotherapy
* At least 1 month since prior corticosteroids except prednisone for respiratory distress
* No prior radiotherapy
Query!
Minimum age
No limit
Query!
Query!
Maximum age
21
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/09/2002
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
1734
Query!
Recruitment in Australia
Recruitment state(s)
QLD,SA,WA
Query!
Recruitment hospital [1]
0
0
Royal Brisbane and Women's Hospital - Herston
Query!
Recruitment hospital [2]
0
0
Women's and Children's Hospital-Adelaide - North Adelaide
Query!
Recruitment hospital [3]
0
0
Princess Margaret Hospital for Children - Perth
Query!
Recruitment postcode(s) [1]
0
0
4029 - Herston
Query!
Recruitment postcode(s) [2]
0
0
5006 - North Adelaide
Query!
Recruitment postcode(s) [3]
0
0
6008 - Perth
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arizona
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Arkansas
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
California
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Colorado
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Connecticut
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Delaware
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
District of Columbia
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Florida
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Georgia
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Hawaii
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Idaho
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Illinois
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Indiana
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Iowa
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Kentucky
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Louisiana
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Maine
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Maryland
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Massachusetts
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
Michigan
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
Minnesota
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
Mississippi
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
Missouri
Query!
Country [25]
0
0
United States of America
Query!
State/province [25]
0
0
Nebraska
Query!
Country [26]
0
0
United States of America
Query!
State/province [26]
0
0
Nevada
Query!
Country [27]
0
0
United States of America
Query!
State/province [27]
0
0
New Hampshire
Query!
Country [28]
0
0
United States of America
Query!
State/province [28]
0
0
New Jersey
Query!
Country [29]
0
0
United States of America
Query!
State/province [29]
0
0
New Mexico
Query!
Country [30]
0
0
United States of America
Query!
State/province [30]
0
0
New York
Query!
Country [31]
0
0
United States of America
Query!
State/province [31]
0
0
North Carolina
Query!
Country [32]
0
0
United States of America
Query!
State/province [32]
0
0
North Dakota
Query!
Country [33]
0
0
United States of America
Query!
State/province [33]
0
0
Ohio
Query!
Country [34]
0
0
United States of America
Query!
State/province [34]
0
0
Oklahoma
Query!
Country [35]
0
0
United States of America
Query!
State/province [35]
0
0
Oregon
Query!
Country [36]
0
0
United States of America
Query!
State/province [36]
0
0
Pennsylvania
Query!
Country [37]
0
0
United States of America
Query!
State/province [37]
0
0
Rhode Island
Query!
Country [38]
0
0
United States of America
Query!
State/province [38]
0
0
South Carolina
Query!
Country [39]
0
0
United States of America
Query!
State/province [39]
0
0
South Dakota
Query!
Country [40]
0
0
United States of America
Query!
State/province [40]
0
0
Tennessee
Query!
Country [41]
0
0
United States of America
Query!
State/province [41]
0
0
Texas
Query!
Country [42]
0
0
United States of America
Query!
State/province [42]
0
0
Utah
Query!
Country [43]
0
0
United States of America
Query!
State/province [43]
0
0
Vermont
Query!
Country [44]
0
0
United States of America
Query!
State/province [44]
0
0
Virginia
Query!
Country [45]
0
0
United States of America
Query!
State/province [45]
0
0
Washington
Query!
Country [46]
0
0
United States of America
Query!
State/province [46]
0
0
West Virginia
Query!
Country [47]
0
0
United States of America
Query!
State/province [47]
0
0
Wisconsin
Query!
Country [48]
0
0
Canada
Query!
State/province [48]
0
0
Alberta
Query!
Country [49]
0
0
Canada
Query!
State/province [49]
0
0
British Columbia
Query!
Country [50]
0
0
Canada
Query!
State/province [50]
0
0
Manitoba
Query!
Country [51]
0
0
Canada
Query!
State/province [51]
0
0
Newfoundland and Labrador
Query!
Country [52]
0
0
Canada
Query!
State/province [52]
0
0
Nova Scotia
Query!
Country [53]
0
0
Canada
Query!
State/province [53]
0
0
Ontario
Query!
Country [54]
0
0
Canada
Query!
State/province [54]
0
0
Quebec
Query!
Country [55]
0
0
Canada
Query!
State/province [55]
0
0
Saskatchewan
Query!
Country [56]
0
0
Israel
Query!
State/province [56]
0
0
Petah Tikua
Query!
Country [57]
0
0
New Zealand
Query!
State/province [57]
0
0
Auckland
Query!
Country [58]
0
0
New Zealand
Query!
State/province [58]
0
0
Christchurch
Query!
Country [59]
0
0
Puerto Rico
Query!
State/province [59]
0
0
San Juan
Query!
Country [60]
0
0
Switzerland
Query!
State/province [60]
0
0
Geneva
Query!
Funding & Sponsors
Primary sponsor type
Other
Query!
Name
Children's Oncology Group
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Government body
Query!
Name [1]
0
0
National Cancer Institute (NCI)
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
This randomized phase III trial is studying different chemotherapy regimens given with or without radiation therapy to compare how well they work in treating children with newly diagnosed Hodgkin's disease. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Giving the drugs in different combinations may kill more cancer cells. Radiation therapy uses high-energy x-rays to damage cancer cells. It is not yet known if chemotherapy is more effective with or without additional chemotherapy and/or radiation therapy in treating Hodgkin's disease.
Query!
Trial website
https://clinicaltrials.gov/study/NCT00025259
Query!
Trial related presentations / publications
Johnston RL, Mottok A, Chan FC, Jiang A, Diepstra A, Visser L, Telenius A, Gascoyne RD, Friedman DL, Schwartz CL, Kelly KM, Scott DW, Horton TM, Steidl C. A gene expression-based model predicts outcome in children with intermediate-risk classical Hodgkin lymphoma. Blood. 2022 Feb 10;139(6):889-893. doi: 10.1182/blood.2021011941. Erratum In: Blood. 2023 Mar 23;141(12):1495. doi: 10.1182/blood.2023019882. Giulino-Roth L, Pei Q, Buxton A, Bush R, Wu Y, Wolden SL, Constine LS, Kelly KM, Schwartz CL, Friedman DL. Subsequent malignant neoplasms among children with Hodgkin lymphoma: a report from the Children's Oncology Group. Blood. 2021 Mar 18;137(11):1449-1456. doi: 10.1182/blood.2020007225. Welch JJG, Schwartz CL, Higman M, Chen L, Buxton A, Kanakry JA, Kahwash SB, Hutchison RE, Friedman DL, Ambinder RF. Epstein-Barr virus DNA in serum as an early prognostic marker in children and adolescents with Hodgkin lymphoma. Blood Adv. 2017 Apr 24;1(11):681-684. doi: 10.1182/bloodadvances.2016002618. eCollection 2017 Apr 25. Friedman DL, Chen L, Wolden S, Buxton A, McCarten K, FitzGerald TJ, Kessel S, De Alarcon PA, Chen AR, Kobrinsky N, Ehrlich P, Hutchison RE, Constine LS, Schwartz CL. Dose-intensive response-based chemotherapy and radiation therapy for children and adolescents with newly diagnosed intermediate-risk hodgkin lymphoma: a report from the Children's Oncology Group Study AHOD0031. J Clin Oncol. 2014 Nov 10;32(32):3651-8. doi: 10.1200/JCO.2013.52.5410. Epub 2014 Oct 13.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Debra Friedman
Query!
Address
0
0
Children's Oncology Group
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00025259
Download to PDF