Treating Young Patients With Newly Diagnosed, Low Stage, Lymphocyte Predominant Hodgkin Disease
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|ClinicalTrials.gov Identifier: NCT00107198|
Recruitment Status : Active, not recruiting
First Posted : April 6, 2005
Results First Posted : August 10, 2016
Last Update Posted : July 14, 2022
|Condition or disease||Intervention/treatment||Phase|
|Ann Arbor Stage I Childhood Hodgkin Lymphoma Ann Arbor Stage II Childhood Hodgkin Lymphoma Childhood Nodular Lymphocyte Predominant Hodgkin Lymphoma||Procedure: Conventional Surgery Drug: Cyclophosphamide Drug: Doxorubicin Hydrochloride Drug: Prednisone Radiation: Radiation Therapy Drug: Vincristine Sulfate||Phase 2|
|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)|
|Actual Study Start Date :||January 2, 2006|
|Actual Primary Completion Date :||October 6, 2015|
|Estimated Study Completion Date :||December 31, 2030|
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).
Procedure: Conventional Surgery
Drug: Doxorubicin Hydrochloride
Given IV or PO
Radiation: Radiation Therapy
Drug: Vincristine Sulfate
- 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
|Principal Investigator:||Burton E Appel||Children's Oncology Group|