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NCT00107198

Treating Young Patients With Newly Diagnosed, Low Stage, Lymphocyte Predominant Hodgkin Disease

Active, enrolled Phase 2 Results posted Last updated 18 September 2025
What this trial tests

Phase 2 trial testing Conventional Surgery in Ann Arbor Stage I Childhood Hodgkin Lymphoma in 188 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline
2 January 2006
Primary endpoint
6 October 2015
31 December 2030

Quick facts

Lead sponsorChildren's Oncology Group
PhasePhase 2
StatusActive, enrolled
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment188
Start date2 January 2006
Primary completion6 October 2015
Estimated completion31 December 2030
Sites170 locations across New Zealand, Israel, Canada, Puerto Rico, Australia, United States

Drugs / interventions tested

Conditions studied

Sponsor

Children's Oncology Group — full company profile →

Who can join

Adults 1 Month to 21, any sex, with Ann Arbor Stage I Childhood Hodgkin Lymphoma or Ann Arbor Stage II Childhood Hodgkin Lymphoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Failure-free Survival (FFS) Primary · 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.

GroupValue95% CI
Surgery or Combination Chemotherapy, With/Without Radiotherapy0.910.86 – 0.95
Event-free Survival Secondary · At 5 years

Failure includes one of the following occurrences as a first event: relapse/progression or second malignancy from enrollment.

GroupValue95% CI
Surgery or Combination Chemotherapy, With/Without Radiotherapy0.850.78 – 0.89
Cure by Surgery Alone in Stage I Resected Patients Secondary · 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.

GroupValue95% CI
Surgery or Combination Chemotherapy, With/Without Radiotherapy0.820.68 – 0.90
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 Secondary · 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.

GroupValue95% CI
Surgery or Combination Chemotherapy, With/Without Radiotherapy0.890.82 – 0.93
Grade 3 or 4 Toxicity Secondary · Any time during chemoradiotherapy, up to the end of 3-cycles of AV-PC induction. Each cycle is 21 days.
GroupValue95% CI
Surgery or Combination Chemotherapy, With/Without Radiotherapy26

Adverse events — posted to ClinicalTrials.gov

Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Surgery or Combination Chemotherapy, With/Without Radiotherapy
Serious: 0/183 (0%)
Deaths:
Other adverse events (21 terms — click to expand)

ReactionSystemSurgery or Combination Che…
Febrile neutropeniaBlood and lymphatic system disorders
VomitingGastrointestinal disorders
NauseaGastrointestinal disorders
Neutrophil count decreasedInvestigations
Infections and infestations - Other, specifyInfections and infestations
White blood cell decreasedInvestigations
HypokalemiaMetabolism and nutrition disorders
ConstipationGastrointestinal disorders
Catheter related infectionInfections and infestations
Device related infectionInfections and infestations
Upper respiratory infectionInfections and infestations
Alanine aminotransferase increasedInvestigations
Lipase increasedInvestigations
AnorexiaMetabolism and nutrition disorders
DehydrationMetabolism and nutrition disorders
HypercalcemiaMetabolism and nutrition disorders
ArthralgiaMusculoskeletal and connective tissue disorders
Pain in extremityMusculoskeletal and connective tissue disorders
Extrapyramidal disorderNervous system disorders
HeadacheNervous system disorders
Personality changePsychiatric disorders

Data from ClinicalTrials.gov NCT00107198 adverse events section.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Minimal Treatment of Low-Risk, Pediatric Lymphocyte-Predominant Hodgkin Lymphoma: A Report From the Children's Oncology Group.
    Appel BE, Chen L, Buxton AB, Hutchison RE, et al · · 2016 · cited 51× · PMID 27185849 · DOI 10.1200/jco.2015.65.3469
  2. Variant histology, IgD and CD30 expression in low-risk pediatric nodular lymphocyte predominant Hodgkin lymphoma: A report from the Children's Oncology Group.
    Untanu RV, Back J, Appel B, Pei Q, et al · · 2018 · cited 16× · PMID 28802087 · DOI 10.1002/pbc.26753
  3. Children's Oncology Group's 2023 blueprint for research: Hodgkin lymphoma.
    Castellino SM, Giulino-Roth L, Harker-Murray P, Kahn JM, et al · · 2023 · cited 13× · PMID 37505794 · DOI 10.1002/pbc.30580
  4. PET Response and Outcome in Low-Risk Nodular Lymphocyte-Predominant Hodgkin Lymphoma: Children's Oncology Group Study AHOD03P1.
    Marks LJ, Wu Y, McCarten KM, Renfro LA, et al · · 2025 · cited 1× · PMID 39953678 · DOI 10.1002/pbc.31606

Verify or expand the search:

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Other Children's Oncology Group trials

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00107198.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing