Treating Young Patients With Newly Diagnosed, Low Stage, Lymphocyte Predominant Hodgkin Disease
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|ClinicalTrials.gov Identifier: NCT00107198|
Recruitment Status : Unknown
Verified March 2016 by Children's Oncology Group.
Recruitment status was: Active, not recruiting
First Posted : April 6, 2005
Results First Posted : August 10, 2016
Last Update Posted : February 9, 2017
|Condition or disease||Intervention/treatment|
|Childhood Lymphocyte Predominant Hodgkin Lymphoma Stage I Childhood Hodgkin Lymphoma Stage II Childhood Hodgkin Lymphoma||Drug: doxorubicin hydrochloride Procedure: conventional surgery Drug: cyclophosphamide Drug: prednisone Drug: vincristine sulfate Radiation: radiation therapy|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||188 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Treatment of Children With Newly-Diagnosed Low Stage Lymphocyte Predominant Hodgkin Disease (LPHD)|
|Study Start Date :||January 2006|
|Primary Completion Date :||November 2012|
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).
Drug: doxorubicin hydrochloride
Other Names:Procedure: conventional surgery
Other Name: surgery, conventionalDrug: cyclophosphamide
Other Names:Drug: prednisone
Given IV or PO
Other Names:Drug: vincristine sulfate
Other Names:Radiation: radiation therapy
- Failure-free Survival (FFS) [ Time Frame: At 5 years ]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.
- Event-free Survival [ Time Frame: At 5 years ]Failure includes one of the following occurrences as a first event: relapse/progression or second malignancy from enrollment.
- Cure by Surgery Alone in Stage I Resected Patients [ Time Frame: At 2 years ]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.
- 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 [ Time Frame: At 5 years ]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.
- Grade 3 or 4 Toxicity [ Time Frame: Any time during chemoradiotherapy, up to the end of 3-cycles of AV-PC induction. Each cycle is 21 days. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00107198
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|Principal Investigator:||Burton Appel, MD||Children's Oncology Group|