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Treatment of Children With Newly-Diagnosed Low Stage Lymphocyte Predominant Hodgkin Disease (LPHD)

1 Month
21 Years
Open (Enrolling)
Childhood Lymphocyte Predominant Hodgkin Lymphoma, Stage I Childhood Hodgkin Lymphoma, Stage II Childhood Hodgkin Lymphoma

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Trial Information

Treatment of Children With Newly-Diagnosed Low Stage Lymphocyte Predominant Hodgkin Disease (LPHD)


I. To preserve the excellent cure rate in patients with lymphocyte predominant Hodgkin
disease (LPHD) while employing a treatment strategy that minimizes the exposure to
chemotherapy and radiation therapy in appropriate patients.

II. 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.

III. 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 adriamycin
(doxorubicin)/vincristine/prednisone/cyclophosphamide (AV-PC) x 3, with involved field
radiation therapy (IFRT) for those who are not in a CR after chemotherapy.

IV. To reduce the potential for long-term toxicity of LPHD treatment.

OUTLINE: This is a pilot study.

Patients with stage IA disease who underwent confirmed complete resection of a single
involved lymph node at diagnosis undergo observation only*.

Patients with stage IA disease who underwent possible complete resection of a single
involved lymph node at diagnosis undergo imaging at 6-7 weeks after surgery. Patients with a
confirmed complete resection by imaging undergo observation only*. Patients who do not
demonstrate complete resection by imaging proceed to combination chemotherapy with or
without radiotherapy.

Patients with stage IA disease who underwent a fine needle aspiration of a single involved
lymph node OR an incomplete resection of a single involved lymph node at diagnosis may
undergo a second surgery to achieve complete resection. Patients who undergo complete
resection during the second surgery undergo imaging at 6-7 weeks after surgery. Patients
with a confirmed complete resection by imaging undergo observation only*. Patients who do
not undergo a second surgery OR do not achieve complete resection with the second surgery
proceed to combination chemotherapy with or without radiotherapy. Patients with stage IA
disease with involvement of more than 1 lymph node OR stage IIA disease proceed directly to
combination chemotherapy with or without radiotherapy.

NOTE: *Patients with recurrent disease after observation only undergo biopsy and restaging
and then proceed to combination chemotherapy with or without radiotherapy. (AS OF AMENDMENT

COMBINATION CHEMOTHERAPY: Patients receive doxorubicin hydrochloride intravenously (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 orally (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 complete response (CR) after 3 courses of
therapy proceed to follow-up. Patients who do not achieve a CR proceed to involved-field

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).

Patients are followed every 3 months for 2 years, every 6 months for 3 years, annually for 5
years, and then every 5 years for 10 years.

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

- 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Failure-free survival (FFS) rate

Outcome Description:

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.

Outcome Time Frame:

At 5 years

Safety Issue:


Principal Investigator

Burton Appel

Investigator Role:

Principal Investigator

Investigator Affiliation:

Children's Oncology Group


United States: Food and Drug Administration

Study ID:




Start Date:

January 2006

Completion Date:

Related Keywords:

  • Childhood Lymphocyte Predominant Hodgkin Lymphoma
  • Stage I Childhood Hodgkin Lymphoma
  • Stage II Childhood Hodgkin Lymphoma
  • Hodgkin Disease
  • Lymphoma



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