Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

ACTIVE_NOT_RECRUITING

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

Lead Sponsor:

Children's Oncology Group

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Ann Arbor Stage I Childhood Hodgkin Lymphoma

Ann Arbor Stage II Childhood Hodgkin Lymphoma

Eligibility:

All Genders

1-21 years

Phase:

PHASE2

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 s...

Detailed Description

PRIMARY OBJECTIVES: I. To preserve the excellent cure rate in patients with lymphocyte predominant Hodgkin disease (LPHD) while employing a treatment strategy that minimizes the exposure to chemother...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    January 2 2006

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    December 31 2030

    Estimated Enrollment :

    188 Patients enrolled

    Trial Details

    Trial ID

    NCT00107198

    Start Date

    January 2 2006

    End Date

    December 31 2030

    Last Update

    September 18 2025

    Active Locations (170)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 43 (170 locations)

    1

    Children's Hospital of Alabama

    Birmingham, Alabama, United States, 35233

    2

    University of Alabama at Birmingham Cancer Center

    Birmingham, Alabama, United States, 35233

    3

    Phoenix Childrens Hospital

    Phoenix, Arizona, United States, 85016

    4

    Banner University Medical Center - Tucson

    Tucson, Arizona, United States, 85719