At a glance
ClinicalIndex Comparison Record- ✓Newly diagnosed, previously untreated, biopsy-proven lymphocyte predominant Hodgkin disease (LPHD)
- ✓LPHD diagnosis confirmed by central pathology review using REAL/WHO classification criteria
- ✓Ann Arbor Stage IA or IIA without bulk disease
- ✓Cardiac function: shortening fraction ≥27% by echocardiogram or ejection fraction ≥50% by MUGA
- ✕B symptoms or bulk disease
- ✕Prior chemotherapy
- ✕Prior radiotherapy
- ✕Recent systemic corticosteroid use within 30 days
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Treatment of Children With Newly-Diagnosed Low Stage Lymphocyte Predominant Hodgkin Disease (LPHD)
In Brief
A Phase 2 clinical trial evaluating Conventional Surgery, Cyclophosphamide, and 4 other interventions for Ann Arbor Stage I Childhood Hodgkin Lymphoma and 2 related conditions. Completed, enrolled 188 participants across 170 sites in 6 countries.
Signals
Detailed Summary
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.
Study Details
Timeline
Arms & Interventions
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).
Interventions
Undergo surgery
Given IV
Given IV
Given IV or PO
Undergo IFRT
Given IV