Treating Young Patients With Newly Diagnosed, Low Stage, Lymphocyte Predominant Hodgkin Disease

Completed · Phase 2

Conditions studied: Ann Arbor Stage I Childhood Hodgkin Lymphoma, Ann Arbor Stage II Childhood Hodgkin Lymphoma, Childhood Nodular Lymphocyte Predominant B-Cell Lymphoma

In brief

This phase II 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.

Key facts

Study ID

NCT00107198

Run by

Children's Oncology Group

People needed

188

Starts

2006-03-10

Expected to finish

2026-03-31

Last updated by the study team

2026-06-05

Who can join

Age: 0 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• University of Alabama at Birmingham Cancer Center — Birmingham, Alabama, United States
• Phoenix Childrens Hospital — Phoenix, Arizona, United States
• Banner University Medical Center - Tucson — Tucson, Arizona, United States
• Arkansas Children's Hospital — Little Rock, Arkansas, United States
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• Kaiser Permanente Downey Medical Center — Downey, California, United States
• City of Hope Comprehensive Cancer Center — Duarte, California, United States
• Miller Children's and Women's Hospital Long Beach — Long Beach, California, United States
• Children's Hospital Los Angeles — Los Angeles, California, United States
• UCSF Benioff Children's Hospital Oakland — Oakland, California, United States
• Kaiser Permanente-Oakland — Oakland, California, United States
• Children's Hospital of Orange County — Orange, California, United States
• Sutter Medical Center Sacramento — Sacramento, California, United States
• Rady Children's Hospital - San Diego — San Diego, California, United States
• UCSF Medical Center-Mount Zion — San Francisco, California, United States
• UCSF Medical Center-Parnassus — San Francisco, California, United States
• Harbor-University of California at Los Angeles Medical Center — Torrance, California, United States
• Children's Hospital Colorado — Aurora, Colorado, United States
• Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center — Denver, Colorado, United States
• University of Connecticut — Farmington, Connecticut, United States
• Connecticut Children's Medical Center — Hartford, Connecticut, United States
• Yale University — New Haven, Connecticut, United States
• Alfred I duPont Hospital for Children — Wilmington, Delaware, United States
• MedStar Georgetown University Hospital — Washington D.C., District of Columbia, United States
• Children's Hospital of Alabama — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.