E2410 – Phase II Trial of Response-adapted Therapy Based on Positron Emission Tomography (PET) for Bulky Stage I and II Classical Hodgkin Lymphoma (HL)

E2410 is a multicenter phase 2 study investigating progression-free survival at 36 months in patients with bulky stage I and II classical Hodgkin lymphoma who are negative on positron emission tomography (PET) after two cycles of doxorubicin hydrochloride, bleomycin sulfate, vinblastine, and dacarbazine (ABVD) and receive four additional cycles of ABVD followed by involved-node radiation therapy (INRT; 30 to 30.6 Gy).

Secondary outcome measures include:

  • PET-negative rate after two cycles of ABVD chemotherapy
  • Progression-free survival at 36 months in patients who were PET-positive after two cycles of ABVD and received four cycles of an escalated regimen of bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone (BEACOPP) followed by INRT (30 to 30.6 Gy)
  • Predictive value (semiquantitative evaluation of FDG update)
  • Pattern of relapse and correlation with radiotherapy fields
  • Reproductive function at baseline and 3 years after ABVD or escalated BEACOPP with specific serum markers
  • Bank tissue blocks, serum, and plasma at baseline and selected time points to assess the prognostic value of various markers.

Physician and Research Staff Educational Materials:

These materials are intended for promotional use among health care professionals and are NOT intended for use as patient educational materials.

  • Trial Overview:  detailed overview of the protocol, disease state, and rationale for therapy based on positron emission tomography/computed tomography-negative (PET/CT-negative) or PET/CT-positive outcomes in classical Hodgkin lymphoma.
  • Pocket Reference Card: trial schema, study objectives, and eligibility requirements on a pocket-sized card for easy reference when consulting with patients in the office or on rounds.
  • Study Summary for Physicians: schema, study objectives, eligibility criteria, and other key information about the study.
  • Physician Fact Sheet: schema, study objectives, eligibility criteria, and other key information about the study.

Patient Educational Materials:

  • Study Summary for Patients: study objectives, eligibility criteria, and a simplified schema in lay language to provide a more visual description of the trial to patients.
  • Patient FAQs: frequently asked questions from patients about treatment, eligibility criteria, and potential enrollment issues, with answers in lay language.

Additional Information at ClinicalTrials.gov:

NCT01390584