Combination Chemotherapy and Radiation Therapy in Treating Young Patients With Newly Diagnosed Hodgkin Lymphoma

Completed · Phase 3

Conditions studied: Childhood Nodular Lymphocyte Predominant Hodgkin Lymphoma, Stage III Childhood Hodgkin Lymphoma, Stage IV Childhood Hodgkin Lymphoma

In brief

This phase III trial is studying how well giving combination chemotherapy together with radiation therapy works in treating young patients with newly diagnosed Hodgkin lymphoma. Drugs used in chemotherapy 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 combination chemotherapy together with radiation therapy may kill more cancer cells.

Key facts

Study ID

NCT01026220

Run by

Children's Oncology Group

People needed

166

Starts

2009-12-07

Expected to finish

2022-03-31

Last updated by the study team

2022-04-28

Who can join

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

You may qualify if…

• Pathologically confirmed newly diagnosed Hodgkin lymphoma (HL) meeting one of the following criteria:
• Classical disease
• Nodular lymphocyte-predominant disease
• Stage III or IV disease with B symptoms, as defined by ≥ 1 of the following:
• Unexplained weight loss > 10% within the past 6 months
• Unexplained recurrent fever > 38°C within the past month
• Recurrent drenching night sweats within the past month
• Creatinine clearance or radioisotope GFR ≥ 70 mL/min OR maximum serum creatinine based on age/gender as follows:
• 0.4 mg/dL (1 to 5 months)
• 0.5 mg/dL (6 to 11 months)
• 0.6 mg/dL (12 to 23 months)
• 0.8 mg/dL (2 to 5 years)
• 1 mg/dL (6 to 9 years)
• 1.2 mg/dL (10 to 12 years)
• 1.5 mg/dL (males) or 1.4 mg/dL (females) (13 to 15 years)
• 1.7 mg/dL (males) or 1.4 mg/dL (females) (≥ 16 years)
• Total bilirubin ≤ 1.5 times upper limit of normal (ULN) for age
• AST or ALT < 2.5 times ULN for age
• Shortening fraction ≥ 27% by ECHO OR ejection fraction ≥ 50% by MUGA (unless due to large mediastinal mass from HL)
• FEV_1/FVC > 60% by pulmonary function tests (PFT) (unless due to large mediastinal mass fromHL)
• For children who are unable to cooperate for PFTs, the criteria are:
• No evidence of dyspnea at rest
• No exercise intolerance
• Pulse oximetry > 92% on room air
• Not pregnant or nursing

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• University of South Alabama — Mobile, Alabama, United States
• Phoenix Childrens Hospital — Phoenix, Arizona, United States
• Arkansas Children's Hospital — Little Rock, Arkansas, United States
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• Southern California Permanente Medical Group — Downey, California, United States
• City of Hope Medical Center — Duarte, California, United States
• Loma Linda University Medical Center — Loma Linda, California, United States
• Miller Children's Hospital — Long Beach, California, United States
• Children's Hospital Los Angeles — Los Angeles, California, United States
• Children's Hospital Central California — Madera, California, United States
• Children's Hospital and Research Center at Oakland — Oakland, California, United States
• Kaiser Permanente-Oakland — Oakland, California, United States
• Childrens Hospital of Orange County — Orange, California, United States
• University of California at Davis Cancer Center — Sacramento, California, United States
• Rady Children's Hospital - San Diego — San Diego, California, United States
• University of California San Francisco Medical Center-Parnassus — San Francisco, California, United States
• Santa Barbara Cottage Hospital — Santa Barbara, 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
• 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
• Children's National Medical Center — Washington D.C., District of Columbia, United States
• Children's Hospital of Alabama — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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