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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT00107198
Ethics application status
Date submitted
5/04/2005
Date registered
6/04/2005
Date last updated
19/09/2024

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:
Ann Arbor Stage I Childhood Hodgkin Lymphoma 0 0
Ann Arbor Stage II Childhood Hodgkin Lymphoma 0 0
Childhood Nodular Lymphocyte Predominant B-Cell 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: Surgery - Conventional Surgery
Treatment: Drugs - Cyclophosphamide
Treatment: Drugs - Doxorubicin Hydrochloride
Treatment: Drugs - Prednisone
Treatment: Other - Radiation Therapy
Treatment: Drugs - Vincristine Sulfate

Experimental: Treatment (surgery, combination chemotherapy, radiotherapy) - COMBINATION CHEMOTHERAPY: Patients receive doxorubicin hydrochloride IV over 10-30 minutes and cyclophosphamide IV over 1 hour on day 1, vincristine IV over 1 minute on days 1 and 8, and prednisone 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 radiotherapy.

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: Surgery: Conventional Surgery
Undergo surgery

Treatment: Drugs: Cyclophosphamide
Given IV

Treatment: Drugs: Doxorubicin Hydrochloride
Given IV

Treatment: Drugs: Prednisone
Given IV or PO

Treatment: Other: Radiation Therapy
Undergo IFRT

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

Outcomes
Primary outcome [1] 0 0
Failure-free Survival (FFS)
Timepoint [1] 0 0
At 5 years
Secondary outcome [1] 0 0
Event-free Survival
Timepoint [1] 0 0
At 5 years
Secondary outcome [2] 0 0
Cure by Surgery Alone in Stage I Resected Patients
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
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)
* 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
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/01/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2030
Actual
Sample size
Target
Accrual to date
Final
188
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA
Recruitment hospital [1] 0 0
The Children's Hospital at Westmead - Westmead
Recruitment hospital [2] 0 0
Westmead Hospital - Westmead
Recruitment hospital [3] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [4] 0 0
Women's and Children's Hospital-Adelaide - North Adelaide
Recruitment hospital [5] 0 0
Princess Margaret Hospital for Children - Perth
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
4029 - Herston
Recruitment postcode(s) [3] 0 0
5006 - North Adelaide
Recruitment postcode(s) [4] 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
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Arkansas
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United States of America
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California
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United States of America
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Colorado
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United States of America
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Connecticut
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United States of America
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Delaware
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United States of America
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District of Columbia
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Hawaii
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United States of America
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Illinois
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United States of America
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Indiana
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United States of America
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Iowa
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United States of America
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Kansas
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United States of America
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Kentucky
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United States of America
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Louisiana
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Maine
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Maryland
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Michigan
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Minnesota
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Mississippi
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Missouri
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Nebraska
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New Hampshire
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New Jersey
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New Mexico
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New York
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North Carolina
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Ohio
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United States of America
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Oklahoma
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Oregon
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United States of America
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Pennsylvania
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United States of America
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Rhode Island
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South Carolina
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South Dakota
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Tennessee
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Texas
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Utah
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Vermont
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Virginia
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Washington
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West Virginia
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Wisconsin
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Canada
State/province [45] 0 0
Alberta
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Canada
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British Columbia
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Canada
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Manitoba
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Canada
State/province [48] 0 0
Newfoundland and Labrador
Country [49] 0 0
Canada
State/province [49] 0 0
Nova Scotia
Country [50] 0 0
Canada
State/province [50] 0 0
Ontario
Country [51] 0 0
Canada
State/province [51] 0 0
Quebec
Country [52] 0 0
Canada
State/province [52] 0 0
Saskatchewan
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Israel
State/province [53] 0 0
Petah Tikua
Country [54] 0 0
New Zealand
State/province [54] 0 0
Auckland
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New Zealand
State/province [55] 0 0
Christchurch
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Puerto Rico
State/province [56] 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/study/NCT00107198
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Burton E Appel
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/study/NCT00107198