Combination Chemotherapy and Radiation Therapy in Treating Young Patients With Newly Diagnosed Hodgkin Lymphoma

Conditions

• Childhood Nodular Lymphocyte Predominant Hodgkin Lymphoma
• Stage III Childhood Hodgkin Lymphoma
• Stage IV Childhood Hodgkin Lymphoma

Eligibility Criteria

Sex

ALL

Age

N/A - 21 Years

Healthy Volunteers

Not accepted

Interventions

• bleomycin sulfate — BIOLOGICAL
  Given IV or SC
• doxorubicin hydrochloride — DRUG
  Given IV
• liposomal vincristine sulfate — DRUG
  Given IV
• vinorelbine tartrate — DRUG
  Given IV
• cyclophosphamide — DRUG
  Given IV
• etoposide phosphate — DRUG
  Given IV
• prednisone — DRUG
  Given IV
• filgrastim — BIOLOGICAL
  Given IV or SC
• ifosfamide — DRUG
  Given IV

Study Details

This phase III trial is studying how well giving combination chemotherapy together with radiation therapy works in treating young patients with newly diagnosed Hodgkin lymphoma. Drugs used in chemotherapy 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 combination chemotherapy together with radiation therapy may kill more cancer cells.

Key Dates

Start date

Dec 7, 2009

Status verified

Dec 2021

Primary completion

Mar 1, 2012

Completion

Mar 31, 2022

Study Design

Enrollment

166 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Regimen I (consolidation therapy)
  Patients receive 2 more courses of ABVE-PC comprising doxorubicin hydrochloride IV over 1-120 minutes and cyclophosphamide IV over 30-60 minutes on days 1 and 2; bleomycin sulfate IV over at least 10 minutes or subcutaneously (SC) and vincristine sulfate IV on days 1 and 8; etoposide IV over 1-2 hours on days 1-3; oral prednisone twice daily on days 1-7; and filgrastim SC or IV daily beginning on day 4 and continuing until blood counts recover. Treatment repeats every 21 days for 2 courses in the absence of unacceptable toxicity or disease progression.
• Experimental: Regimen II (consolidation therapy)
  Patients receive ifosfamide IV continuously on days 1-4, vinorelbine ditartrate IV over 6-10 minutes on days 1 and 5, and filgrastim SC or IV beginning on day 6 and continuing until blood counts recover. Treatment repeats every 21 days for 2 courses in the absence of unacceptable toxicity or disease progression. Patients then receive 2 more courses of ABVE-PC in the absence of unacceptable toxicity or disease progression.
• Experimental: Induction: all patient
  All patients receive ABVE-PC induction therapy then they are assigned to Group 2 (RER), Group 3 (SER) or taken off study if they develop progressive disease.

Primary Outcome Measure

Second-event-free Survival [ Time Frame: At 4 years from enrollment ]

Locations (156)

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