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

NCT01652261 | Withdrawn Phase 3 DMC

• 2 other identifiers: EORTC-20101-231012011-005473-22
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Hodgkin Lymphoma

Keywords

advanced stage

Outcome Measures

Primary Outcomes (1)

• Freedom from treatment failure

  9 years after first patient in (FPI)

Secondary Outcomes (5)

• 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

• Long-term toxicity in terms of second malignancies, cardiovascular and pulmonary events

  9 years after FPI

Study Arms (2)

experimental arm

EXPERIMENTAL

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

standard arm

ACTIVE COMPARATOR

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

Interventions

ABVD + FDG-PET/CT Scan treatment adaptation DRUG

experimental arm

BEACOPPesc DRUG

experimental arm; standard arm

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead
• Polish Lymphoma Research Group: collaborator

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Related Publications (1)

• Kreuzberger N, Goldkuhle M, von Tresckow B, Kobe C, Sickinger MT, Monsef I, Skoetz N. Positron emission tomography-adapted therapy for first-line treatment in adults with Hodgkin lymphoma. Cochrane Database Syst Rev. 2025 Mar 26;3(3):CD010533. doi: 10.1002/14651858.CD010533.pub3.

  PMID: 40135712 DERIVED

MeSH Terms

Conditions

Hodgkin Disease

Interventions

ABVD protocol

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• 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 CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2012
• First Posted: July 30, 2012
• Study Start: May 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: February 15, 2021

Record last verified: 2014-06

Locations

DK (1)