EuroNet PHL-LP1

• Research type

  Research Study

• Full title

  First international Inter-Group Study for nodular lymphocyte-predominant Hodgkin’s Lymphoma in Children and Adolescents

• IRAS ID

  1180

• Contact name

  Ananth Shankar

• Sponsor organisation

  Martin Luther University of Halle/Wittenberg

• Eudract number

  2007-004092-19

• Clinicaltrials.gov Identifier

  NCT01088750

• Research summary

  This European study of nodular Lymphocyte Predominant Hodgkin's Lymphoma will ascertain whether children with early stage disease [stages IA & IIA] can be managed safely with surgery and little or no chemotherapy. If the disease is completely resected a 'Watch and Wait' approach is adopted; otherwise patients will receive three cycles of non-intensive chemotherapy.

  Summary of results
  270 children below the age of 18 years of age were enrolled in 104 hospitals across 8 European nations and in the U.S.A. Twenty three patients were subsequently excluded for a variety of reasons that included: treatment was performed in a non-accredited centre, disease stage was greater than IIA, and withdrawal of consent before commencing treatment. Eighty-seven patients were assigned to the active surveillance group after surgery to remove the diseased lymph node. Six of these patients subsequently relapsed (their disease came back) and entered the trial a second time round but this time, to the CVP arm. One hundred and sixty six patients received CVP chemotherapy; 160 patients receiving CVP as first line treatment and 6 patients receiving CVP as second line treatment after relapse (where the disease came back) in the active surveillance group.
  The 5-year Progression-Free Survival (the length of time a patient lives with nLPHL without it getting worse or simply put, how effective the treatment has been) for patients on active surveillance after complete lymph node excision is around 80%, which is excellent.
  The Progression-Free Survival for patients who achieved a complete remission based on FDG PET was 91.3%. Two patients died – one due a heart failure related to a viral infection while in clinical remission and the other died to due recurrent nLPHL. There were no treatment-related deaths.
  In conclusion, patients with early stage nLPHL do well after complete resection. Those patients who receive CVP chemotherapy , because complete surgical removal of the lymph nodes was not possible, also have an excellent outcome with low-intensity chemotherapy if they achieve a complete remission
  

• REC name

  East Midlands - Derby Research Ethics Committee

• REC reference

  11/EM/0358

• Date of REC Opinion

  5 Dec 2011

• REC opinion

  Further Information Favourable Opinion