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 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

188

participants targeted

Target at P75+ for phase_2

Timeline

56mo left

Started Jan 2006

Longer than P75 for phase_2

Geographic Reach

6 countries

170 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

25 years study duration

Study Progress81%

Jan 2006Dec 2030

First Submitted

Initial submission to the registry

April 5, 2005

Completed

1 day until next milestone

First Posted

Study publicly available on registry

April 6, 2005

Completed

9 months until next milestone

Study Start

First participant enrolled

January 2, 2006

Completed

9.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 6, 2015

Completed

10 months until next milestone

Results Posted

Study results publicly available

August 10, 2016

Completed

14.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Expected

Last Updated

September 18, 2025

Status Verified

August 1, 2025

Enrollment Period

9.8 years

First QC Date

April 5, 2005

Results QC Date

June 30, 2016

Last Update Submit

September 16, 2025

Conditions

Ann Arbor Stage I Childhood Hodgkin Lymphoma Ann Arbor Stage II Childhood Hodgkin Lymphoma Childhood Nodular Lymphocyte Predominant B-Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

Failure-free Survival (FFS)
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.
At 5 years

Secondary Outcomes (4)

Event-free Survival
At 5 years
Cure by Surgery Alone in Stage I Resected Patients
At 2 years
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
At 5 years
Grade 3 or 4 Toxicity
Any time during chemoradiotherapy, up to the end of 3-cycles of AV-PC induction. Each cycle is 21 days.

Study Arms (1)

Treatment (surgery, combination chemotherapy, radiotherapy)

EXPERIMENTAL

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 SurgeryDrug: CyclophosphamideDrug: Doxorubicin HydrochlorideDrug: PrednisoneRadiation: Radiation TherapyDrug: Vincristine Sulfate