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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00107198




Registration number
NCT00107198
Ethics application status
Date submitted
5/04/2005
Date registered
6/04/2005
Date last updated
9/02/2017

Titles & IDs
Public title
Treating Young Patients With Newly Diagnosed, Low Stage, Lymphocyte Predominant Hodgkin Disease
Scientific title
Treatment of Children With Newly-Diagnosed Low Stage Lymphocyte Predominant Hodgkin Disease (LPHD)
Secondary ID [1] 0 0
NCI-2009-00376
Secondary ID [2] 0 0
AHOD03P1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Childhood Lymphocyte Predominant Hodgkin Lymphoma 0 0
Stage I Childhood Hodgkin Lymphoma 0 0
Stage II Childhood Hodgkin Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Cancer 0 0 0 0
Hodgkin's

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - doxorubicin hydrochloride
Treatment: Surgery - conventional surgery
Treatment: Drugs - cyclophosphamide
Treatment: Drugs - prednisone
Treatment: Drugs - vincristine sulfate
Treatment: Other - radiation therapy

Experimental: Surgery or combination chemotherapy, with/without radiotherapy - Patients receive doxorubicin hydrochloride 50 mg/m2 IV over 10-30 minutes and cyclophosphamide 800 mg/mg2 IV over 1 hour on day 1, vincristine sulfate 1.4 mg/m2 IV (2.8 mg maximum) over 1 minute on days 1 and 8, and prednisone 40 mg/m2/day PO or IV two or three times daily on days 1-7. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve CR after 3 courses of therapy proceed to follow-up. Patients who do not achieve a CR proceed to involved-field radiation therapy (IFRT).
IFRT: Beginning within 3 weeks after completion of combination chemotherapy, patients undergo IFRT once daily, 5 days a week for 2.8 weeks (14 treatments).


Treatment: Drugs: doxorubicin hydrochloride
Given IV

Treatment: Surgery: conventional surgery
Undergo surgery

Treatment: Drugs: cyclophosphamide
Given IV

Treatment: Drugs: prednisone
Given IV or PO

Treatment: Drugs: vincristine sulfate
Given IV

Treatment: Other: radiation therapy
Undergo IFRT

Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Surgery
Intervention code [3] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Failure-free Survival (FFS) - The time to a treatment (strategy) failure, where failure includes one of the following occurrences as a first event: disseminated disease (> Stage I/II) progression or recurrence at any time, local disease progression or recurrence anytime during or after treatment with AV-PC +/- IFRT, occurrence of a second malignant neoplasm, death from any cause.
Timepoint [1] 0 0
At 5 years
Secondary outcome [1] 0 0
Event-free Survival - Failure includes one of the following occurrences as a first event: relapse/progression or second malignancy from enrollment.
Timepoint [1] 0 0
At 5 years
Secondary outcome [2] 0 0
Cure by Surgery Alone in Stage I Resected Patients - To estimate the proportion of Stage I patients (with a single involved lymph node that is totally resected) who can be cured with surgery alone.
Timepoint [2] 0 0
At 2 years
Secondary outcome [3] 0 0
Cure by AV-PC x 3 or AV-PC x 3 + IFRT for Stage I Unresected, Stage I Resected Whose Disease Recurred, and Stage II Patients - To estimate the proportions of Stage I unresected, Stage I resected (whose disease has recurred after observation), and Stage II LPHD patients who can be cured with AV-PC x 3, with IFRT for those who are not in a CR after chemotherapy.
Timepoint [3] 0 0
At 5 years
Secondary outcome [4] 0 0
Grade 3 or 4 Toxicity
Timepoint [4] 0 0
Any time during chemoradiotherapy, up to the end of 3-cycles of AV-PC induction. Each cycle is 21 days.

Eligibility
Key inclusion criteria
- Patients with newly diagnosed, previously untreated, biopsy-proven lymphocyte
predominant Hodgkin disease (LPHD) are eligible for this protocol as follows:

- Diagnosis of LPHD must be made using the Revised European American Lymphoma
(REAL)/World Health Organization (WHO) classification criteria and will be
confirmed by rapid pathology central review

- Clinical stages as follows:

- Stage IA without bulk disease

- Stage IIA without bulk disease

- Patients with "B" symptoms or bulk disease are NOT eligible for this study

- Slides for rapid central pathology review must be sent to the Biopathology Center
(BPC)

- Serum glutamic oxalo-acetic transaminase (SGOT) (aspartate aminotransferase [AST]) or
serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 2.5
times upper limit of normal (ULN)

- Total bilirubin =< 1.5 times ULN

- Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min

- Creatinine based on age/gender as follows:

- No greater than 0.4 mg/dL (for patients 1 to 5 months of age)

- No greater than 0.5 mg/dL (for patients 6 to 11 months of age)

- No greater than 0.6 mg/dL (for patients 1 year of age)

- No greater than 0.8 mg/dL (for patients 2 to 5 years of age)

- No greater than 1.0 mg/dL (for patients 6 to 9 years of age)

- No greater than 1.2 mg/dL (for patients 10 to 12 years of age)

- No greater than 1.4 mg/dL (for female patients >= 13 years of age)

- No greater than 1.5 mg/dL (for male patients 13 to 15 years of age)

- No greater than 1.7 mg/dL (for male patients >= 16 years of age)

- For patients that will receive chemotherapy, shortening fraction of >= 27% by
echocardiogram or ejection fraction of >= 50% by multigated radionuclide angiogram
(MUGA)

- Lactating females must agree that they will not breastfeed a child if they are to
receive chemotherapy or radiation treatment*

- Female patients of childbearing potential must have a negative pregnancy test if they
are to receive chemotherapy or radiation treatment*

- Males and females of reproductive potential may not participate unless they have
agreed to use an effective contraceptive method if they are to receive chemotherapy or
radiation treatment*

- Note: *Pregnant or breastfeeding women with stage I, single involved lymph node and
confirmed (by Quality Assurance Review Center [QARC ]) total resection, are eligible
for the observation arm only; no chemotherapy or radiation treatment will be
administered to pregnant or breastfeeding women

- No prior chemotherapy

- More than 30 days since prior systemic corticosteroids

- No prior radiotherapy

- All patients and/or their parents or legal guardians must sign a written informed
consent
Minimum age
1 Month
Maximum age
21 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,WA
Recruitment hospital [1] 0 0
Women's and Children's Hospital-Adelaide - North Adelaide
Recruitment hospital [2] 0 0
Princess Margaret Hospital for Children - Perth
Recruitment postcode(s) [1] 0 0
5006 - North Adelaide
Recruitment postcode(s) [2] 0 0
6008 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Connecticut
Country [7] 0 0
United States of America
State/province [7] 0 0
District of Columbia
Country [8] 0 0
United States of America
State/province [8] 0 0
Florida
Country [9] 0 0
United States of America
State/province [9] 0 0
Georgia
Country [10] 0 0
United States of America
State/province [10] 0 0
Hawaii
Country [11] 0 0
United States of America
State/province [11] 0 0
Illinois
Country [12] 0 0
United States of America
State/province [12] 0 0
Indiana
Country [13] 0 0
United States of America
State/province [13] 0 0
Kentucky
Country [14] 0 0
United States of America
State/province [14] 0 0
Maine
Country [15] 0 0
United States of America
State/province [15] 0 0
Maryland
Country [16] 0 0
United States of America
State/province [16] 0 0
Michigan
Country [17] 0 0
United States of America
State/province [17] 0 0
Minnesota
Country [18] 0 0
United States of America
State/province [18] 0 0
Mississippi
Country [19] 0 0
United States of America
State/province [19] 0 0
Missouri
Country [20] 0 0
United States of America
State/province [20] 0 0
New Hampshire
Country [21] 0 0
United States of America
State/province [21] 0 0
New Jersey
Country [22] 0 0
United States of America
State/province [22] 0 0
New York
Country [23] 0 0
United States of America
State/province [23] 0 0
North Carolina
Country [24] 0 0
United States of America
State/province [24] 0 0
Ohio
Country [25] 0 0
United States of America
State/province [25] 0 0
Oklahoma
Country [26] 0 0
United States of America
State/province [26] 0 0
Oregon
Country [27] 0 0
United States of America
State/province [27] 0 0
Pennsylvania
Country [28] 0 0
United States of America
State/province [28] 0 0
Rhode Island
Country [29] 0 0
United States of America
State/province [29] 0 0
South Carolina
Country [30] 0 0
United States of America
State/province [30] 0 0
South Dakota
Country [31] 0 0
United States of America
State/province [31] 0 0
Tennessee
Country [32] 0 0
United States of America
State/province [32] 0 0
Texas
Country [33] 0 0
United States of America
State/province [33] 0 0
Utah
Country [34] 0 0
United States of America
State/province [34] 0 0
Virginia
Country [35] 0 0
United States of America
State/province [35] 0 0
Washington
Country [36] 0 0
United States of America
State/province [36] 0 0
West Virginia
Country [37] 0 0
United States of America
State/province [37] 0 0
Wisconsin
Country [38] 0 0
Canada
State/province [38] 0 0
Alberta
Country [39] 0 0
Canada
State/province [39] 0 0
British Columbia
Country [40] 0 0
Canada
State/province [40] 0 0
Manitoba
Country [41] 0 0
Canada
State/province [41] 0 0
Newfoundland and Labrador
Country [42] 0 0
Canada
State/province [42] 0 0
Nova Scotia
Country [43] 0 0
Canada
State/province [43] 0 0
Ontario
Country [44] 0 0
Canada
State/province [44] 0 0
Quebec
Country [45] 0 0
Canada
State/province [45] 0 0
Saskatchewan
Country [46] 0 0
Israel
State/province [46] 0 0
Petah Tikua
Country [47] 0 0
Puerto Rico
State/province [47] 0 0
San Juan

Funding & Sponsors
Primary sponsor type
Other
Name
Children's Oncology Group
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Cancer Institute (NCI)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This clinical trial is studying how well surgery and/or combination chemotherapy with or
without radiation therapy or observation only work in treating young patients with newly
diagnosed stage I or stage II lymphocyte predominant Hodgkin disease (LPHD). Surgery may be
an effective treatment for LPHD. Drugs used in chemotherapy, such as doxorubicin,
vincristine, prednisone, and cyclophosphamide, work in different ways to stop the growth of
cancer cells, either by killing the cells or by stopping them from dividing. Radiation
therapy uses high-energy x-rays to kill cancer cells. Giving more than one drug (combination
chemotherapy) with or without radiation therapy may kill more cancer cells.
Trial website
https://clinicaltrials.gov/show/NCT00107198
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Burton Appel, MD
Address 0 0
Children's Oncology Group
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT00107198