Clinical trial · Interventional
Treating Young Patients With Newly Diagnosed, Low Stage, Lymphocyte Predominant Hodgkin Disease
Treatment of Children With Newly-Diagnosed Low Stage Lymphocyte Predominant Hodgkin Disease (LPHD)
NCT00107198CI-TRIAL-00113781completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ann Arbor Stage I Childhood Hodgkin Lymphoma | — | UNRESOLVED | — |
| Ann Arbor Stage II Childhood Hodgkin Lymphoma | — | UNRESOLVED | — |
| Childhood Nodular Lymphocyte Predominant B-Cell Lymphoma | Childhood Nodular Lymphocyte Predominant B-Cell Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventional Surgery | Procedure | — | UNRESOLVED |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Doxorubicin Hydrochloride | Drug | Doxorubicin | ALIAS |
| Prednisone | Drug | Prednisone | ALIAS |
| Radiation Therapy | Radiation | — | UNRESOLVED |
| Vincristine Sulfate | Drug | Vincristine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (surgery, combination chemotherapy, radiotherapy)
- description
- 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).
- interventionNames
- Procedure: Conventional Surgery
- Drug: Cyclophosphamide
- Drug: Doxorubicin Hydrochloride
- Drug: Prednisone
- Radiation: Radiation Therapy
- Drug: Vincristine Sulfate
Primary outcomes (1)
- measure
- Failure-free Survival (FFS)
- timeFrame
- At 5 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Month
- Maximum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria:
* Patients with newly diagnosed, previously untreated, biopsy-proven lymphocyte predominant Hodgkin disease (LPHD) are eligible for this protocol as follows:
* Diagnosis of LPHD must be made using the Revised European American Lymphoma (REAL)/World Health Organization (WHO) classification criteria and will be confirmed by rapid pathology central review
* Clinical stages as follows:
* Stage IA without bulk disease
* Stage IIA without bulk disease
* Patients with "B" symptoms or bulk disease are NOT eligible for this study
* Slides for rapid central pathology review must be sent to the Biopathology Center (BPC)
* Serum glutamic oxalo-acetic transaminase (SGOT) (aspartate aminotransferase \[AST\]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \[ALT\]) \< 2.5 times upper limit of normal (ULN)
* Total bilirubin =\< 1.5 times ULN
* Creatinine clearance or radioisotope glomerular filtration rate (GFR) \>= 70 mL/min
* Creatinine based on age/gender as follows:
* No greater than 0.4 mg/dL (for patients 1 to 5 months of age)
* No greater than 0.5 mg/dL (for patients 6 to 11 months of age)
* No greater than 0.6 mg/dL (for patients 1 year of age)
* No greater than 0.8 mg/dL (for patients 2 to 5 years of age)
* No greater than 1.0 mg/dL (for patients 6 to 9 years of age)
* No greater than 1.2 mg/dL (for patients 10 to 12 years of age)
* No greater than 1.4 mg/dL (for female patients \>= 13 years of age)
* No greater than 1.5 mg/dL (for male patients 13 to 15 years of age)
* No greater than 1.7 mg/dL (for male patients \>= 16 years of age)
* Shortening fraction of \>= 27% by echocardiogram or ejection fraction of \>= 50% by multigated radionuclide angiogram (MUGA)
* Lactating females must agree that they will not breastfeed a child if they are to receive chemotherapy or radiation treatment\*
* Female patients of childbearing potential must have a negative pregnancy test if they are to receive chemotherapy or radiation treatment\*
* Males and females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method if they are to receive chemotherapy or radiation treatment\*
* Note: \*Pregnant or breastfeeding women with stage I, single involved lymph node and confirmed (by Quality Assurance Review Center \[QARC \]) total resection, are eligible for the observation arm only; no chemotherapy or radiation treatment will be administered to pregnant or breastfeeding women
* No prior chemotherapy
* More than 30 days since prior systemic corticosteroids
* No prior radiotherapy
* All patients and/or their parents or legal guardians must sign a written informed consentReferences
Publications (1)
- DERIVEDCastellino SM, Giulino-Roth L, Harker-Murray P, Kahn JM, Forlenza C, Cho S, Hoppe B, Parsons SK, Kelly KM; COG Hodgkin Lymphoma Committee. Children's Oncology Group's 2023 blueprint for research: Hodgkin lymphoma. Pediatr Blood Cancer. 2023 Sep;70 Suppl 6(Suppl 6):e30580. doi: 10.1002/pbc.30580. Epub 2023 Jul 28. PMID 37505794