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

February 11, 2021 updated by: European Organisation for Research and Treatment of Cancer - EORTC

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Rigshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 56 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: experimental arm

An experimental arm (early FDG-PET/CT-response adapted), where all patients are initially treated with a single cycle of ABVD. Very early FDG-PET/CT-negative patients continue on ABVD therapy to a total of six cycles. Very early FDG-PET/CT-positive patients receive 3 cycles of BEACOPPesc followed by another 3 cycles of BEACOPPesc. Mid-treatment evaluation is performed after 4 cycles. In case of treatment failure (less than partial remission (PR)), the patient goes off protocol treatment.

Only patients with residual FDG-PET/CT-positive disease after chemotherapy will receive radiotherapy (36 Gy/18 fractions on the FDG-PET/CT-positive residual mass(es)).
Drug: ABVD + FDG-PET/CT Scan treatment adaptation
Drug: BEACOPPesc
Active Comparator: standard arm

A standard arm, where patients are treated with four cycles of BEACOPPesc followed by 2 cycles of BEACOPPesc. FDG-PET/CT is performed after one cycle, but with no therapeutic consequences. Mid-treatment evaluation is performed after four cycles. In case of treatment failure (less than PR), the patient goes off protocol treatment.

Only patients with residual FDG-PET/CT-positive disease after chemotherapy will receive radiotherapy (36 Gy/18 fractions on the FDG-PET/CT-positive residual mass(es)).
Drug: BEACOPPesc

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Freedom from treatment failure
Time Frame: 9 years after first patient in (FPI)
9 years after first patient in (FPI)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
response at the end of therapy
Time Frame: 9 years after FPI
9 years after FPI
Progression-free survival
Time Frame: 9 years after FPI
9 years after FPI
Overall survival
Time Frame: 9 years after FPI
9 years after FPI
Acute toxicity
Time Frame: 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.
9 years after FPI
Long-term toxicity in terms of second malignancies, cardiovascular and pulmonary events
Time Frame: 9 years after FPI
9 years after FPI

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Collaborators

Polish Lymphoma Research Group

Investigators

  • Study Chair: Martin Hutchings, Rigshospitalet, Denmark
  • Study Chair: Berthe Aleman, The Netherlands Cancer Institute, Amsterdam, The Netherlands
  • Study Chair: Gustaaf van IMHOFF, University Medical Center Groningen
  • Study Chair: Wim Oyen, Radboud University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2013

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

July 18, 2012

First Submitted That Met QC Criteria

July 27, 2012

First Posted (Estimate)

July 30, 2012

Study Record Updates

Last Update Posted (Actual)

February 15, 2021

Last Update Submitted That Met QC Criteria

February 11, 2021

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EORTC-20101-23101
  • 2011-005473-22 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hodgkin Lymphoma

Clinical Trials on ABVD + FDG-PET/CT Scan treatment adaptation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cambodia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe