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Very Early FDG-PET/CT-response Adapted Therapy for Advanced Stage Hodgkin Lymphoma, a Randomized Phase III Non-inferiority Study of the EORTC Lymphoma Group


Phase 3
18 Years
60 Years
Open (Enrolling)
Both
Hodgkin Lymphoma

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Trial Information

Very Early FDG-PET/CT-response Adapted Therapy for Advanced Stage Hodgkin Lymphoma, a Randomized Phase III Non-inferiority Study of the EORTC Lymphoma Group

Inclusion Criteria


Inclusion criteria:

- Previously untreated, histologically proven classical Hodgkin lymphoma

- Clinical stages III/IV (Ann Arbor)

- Age 18-60

- WHO performance 0-2

- Adequate organ function

- Patients of childbearing/reproductive potential should use adequate birth control
measures during the whole duration of study treatment.

- Written informed consent according to ICH/EU Good Clinical Practice, and
national/local regulations

Exclusion criteria:

- Pregnancy or lactation

- Specific contraindications to BEACOPPesc therapy, including:

- Poorly controlled diabetes mellitus

- HIV infection,

- Chronic active hepatitis B and/or hepatitis C

- Concomitant or previous malignancies with the exception of basal cell skin tumors,
adequately treated carcinoma in situ of the cervix and any cancer that has been in
complete remission for >5 years

- Psychological, familial, sociological or geographical condition potentially hampering
compliance with the study protocol and follow-up schedule; those conditions should be
discussed with the patient before registration in the trial

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Freedom from treatment failure

Outcome Time Frame:

9 years after first patient in (FPI)

Safety Issue:

No

Principal Investigator

Martin Hutchings

Investigator Role:

Study Chair

Investigator Affiliation:

Rigshospitalet, Denmark

Authority:

Belgium: Federal Agency for Medicinal Products and Health Products

Study ID:

EORTC-20101-23101

NCT ID:

NCT01652261

Start Date:

May 2013

Completion Date:

March 2022

Related Keywords:

  • Hodgkin Lymphoma
  • advanced stage
  • Hodgkin Disease
  • Lymphoma

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