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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: A Non-Randomized Phase III Study of Response Adapted Therapy for the Treatment of Children With Newly Diagnosed High Risk Hodgkin Lymphoma

Brief Summary: 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.

Detailed Summary:

PRIMARY OBJECTIVES:

I. To maintain the overall survival (as defined by 4-year "second-event" free survival) for subjects with high risk Hodgkin lymphoma at or above 95%.

SECONDARY OBJECTIVES:

I. To maintain 3-year event-free survival for subjects with high risk Hodgkin lymphoma at or above 93%.

II. To maintain comparable overall survival (as defined by 4-year "second-event" free survival) between subjects with high risk Hodgkin lymphoma who have a rapid or slow response to the initial 2 cycles of ABVE-PC* by intensifying therapy through the addition of 2 cycles of ifosfamide/vinorelbine in those with a slow early response.

III. To investigate whether very early response assessment measured by FDG-PET after 1 cycle of chemotherapy identifies a subject cohort that can be studied in future trials and that is distinguishable from currently defined RER after 2 cycles.

IV. To describe the patterns of relapse after ABVE-PC* and risk-adapted radiotherapy.

OUTLINE: This is a multicenter study.

INDUCTION THERAPY (ABVE-PC): Patients receive 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 phosphate 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 toxic
Sponsor: Children's Oncology Group

Current Primary Outcome:

  • Second-event-free survival [ Time Frame: 4 years ]
  • Safety analysis and monitoring of toxic death [ Time Frame: Up to 10 years ]


Original Primary Outcome:

  • Toxic death, defined as death primarily attributable to treatment
  • Early response after 2 courses of ABVE-PC chemotherapy
  • "Second-event"-free survival


Current Secondary Outcome:

  • EFS of 93% [ Time Frame: 3 years ]
  • Achieve a similar outcome for patients with RER and SER through intensification of therapy for SER patients [ Time Frame: Up to 10 years ]
  • Prognostic significance of "very early response" as assessed by PET scan [ Time Frame: After 1 course of therapy ]
  • Patterns of relapse after ABVE-PC and risk-adapted RT [ Time Frame: Up to 10 years ]
  • Grade 3 and 4 non-hematologic toxicities [ Time Frame: Up to 10 years ]
    These toxicities include specifically: GI toxicity and infections.
  • Overall survival [ Time Frame: Up to 10 years ]


Original Secondary Outcome:

  • Grade 3 and 4 non-hematologic toxicities, specifically GI toxicity and infections
  • Event-free survival
  • Overall survival


Information By: Children's Oncology Group

Dates:
Date Received: December 3, 2009
Date Started: December 2009
Date Completion:
Last Updated: November 10, 2016
Last Verified: November 2016