Very Early FDG-PET/CT-response Adapted Therapy for Advanced Hodgkin Lymphoma (H11)

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

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01652261

Acronym

H11

Enrollment

Registered

2012-07-30

Start date

2013-05-31

Completion date

2014-10-31

Last updated

2021-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hodgkin Lymphoma

Keywords

advanced stage

Brief summary

The main objective of the trial is to show that doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD)-based response-adapted therapy for advanced-stage Hodgkin lymphoma, with treatment intensification (bleomycin, etoposide, adriamycin, cyclophosphamide, vincristine, procarbazine, and prednisone (BEACOPPesc) in case of a positive fluorodeoxyglucose (FDG) positron emission tomography (PET) computed tomography (CT) after one cycle of ABVD, has non-inferior efficacy compared with the intensive BEACOPPesc regimen. A second objective is to assess the prognostic value of FDG-PET/CT after one cycle of BEACOPPesc.

Interventions

DRUGABVD + FDG-PET/CT Scan treatment adaptation

DRUGBEACOPPesc

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Freedom from treatment failure	9 years after first patient in (FPI)

Secondary

Measure	Time frame	Description
response at the end of therapy	9 years after FPI	—
Progression-free survival	9 years after FPI	—
Overall survival	9 years after FPI	—
Acute toxicity	9 years after FPI	* Hematological toxicity (blood cell count) can be significant especially for patients who will receive BEACOPPesc . * Bleomycine interstitial pneumonitis has been frequently reported and requires the immediate stop of further bleomycine administration. * Rarely, procarbazine allergy and intolerance has been reported. * Nausea & vomiting due to cyclophosphamide, doxorubicin, dacarbazine and procarbazine may be significant. * Total reversible alopecia occurs in most cases. * Escalated BEACOPP-related toxic deaths have been reported but do not exceed those observed with standard ABVD.
Long-term toxicity in terms of second malignancies, cardiovascular and pulmonary events	9 years after FPI	—

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026