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

Primary Purpose

Hodgkin Lymphoma

Status
Withdrawn
Phase
Phase 3
Locations
Denmark
Study Type
Interventional
Intervention
ABVD + FDG-PET/CT Scan treatment adaptation
BEACOPPesc
Sponsored by
European Organisation for Research and Treatment of Cancer - EORTC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hodgkin Lymphoma focused on measuring advanced stage

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Rigshospitalet

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

experimental arm

standard arm

Arm Description

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)).

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)).

Outcomes

Primary Outcome Measures

Freedom from treatment failure

Secondary Outcome Measures

response at the end of therapy
Progression-free survival
Overall survival
Acute toxicity
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

Full Information

First Posted
July 18, 2012
Last Updated
February 11, 2021
Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Collaborators
Polish Lymphoma Research Group
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1. Study Identification

Unique Protocol Identification Number
NCT01652261
Brief Title
Very Early FDG-PET/CT-response Adapted Therapy for Advanced Hodgkin Lymphoma (H11)
Acronym
H11
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Withdrawn
Why Stopped
Study closed due to lack of recruitment
Study Start Date
May 2013 (Actual)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Collaborators
Polish Lymphoma Research Group

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hodgkin Lymphoma
Keywords
advanced stage

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
experimental arm
Arm Type
Experimental
Arm Description
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)).
Arm Title
standard arm
Arm Type
Active Comparator
Arm Description
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)).
Intervention Type
Drug
Intervention Name(s)
ABVD + FDG-PET/CT Scan treatment adaptation
Intervention Type
Drug
Intervention Name(s)
BEACOPPesc
Primary Outcome Measure Information:
Title
Freedom from treatment failure
Time Frame
9 years after first patient in (FPI)
Secondary Outcome Measure Information:
Title
response at the end of therapy
Time Frame
9 years after FPI
Title
Progression-free survival
Time Frame
9 years after FPI
Title
Overall survival
Time Frame
9 years after FPI
Title
Acute toxicity
Description
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.
Time Frame
9 years after FPI
Title
Long-term toxicity in terms of second malignancies, cardiovascular and pulmonary events
Time Frame
9 years after FPI

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Hutchings
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Berthe Aleman
Organizational Affiliation
The Netherlands Cancer Institute, Amsterdam, The Netherlands
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Gustaaf van IMHOFF
Organizational Affiliation
University Medical Center Groningen
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Wim Oyen
Organizational Affiliation
Radboud University Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark

12. IPD Sharing Statement

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

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