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

NCT ID: NCT01652261

Last Updated: 2021-02-15

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2014-10-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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)).

Group Type: EXPERIMENTAL

ABVD + FDG-PET/CT Scan treatment adaptation

Intervention Type: DRUG

BEACOPPesc

Intervention Type: DRUG

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)).

Group Type: ACTIVE_COMPARATOR

BEACOPPesc

Intervention Type: DRUG

Interventions

ABVD + FDG-PET/CT Scan treatment adaptation

Intervention Type: DRUG

BEACOPPesc

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Polish Lymphoma Research Group

NETWORK

Sponsor Role: collaborator

European Organisation for Research and Treatment of Cancer - EORTC

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Martin Hutchings

Role: STUDY_CHAIR

Rigshospitalet, Denmark

Berthe Aleman

Role: STUDY_CHAIR

The Netherlands Cancer Institute, Amsterdam, The Netherlands

Gustaaf van IMHOFF

Role: STUDY_CHAIR

University Medical Center Groningen

Wim Oyen

Role: STUDY_CHAIR

Radboud University Medical Center

Locations

Rigshospitalet

Copenhagen, , Denmark

Countries

Denmark

References

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.

Reference Type: DERIVED

PMID: 40135712 (View on PubMed)

Other Identifiers

2011-005473-22

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

EORTC-20101-23101

Identifier Type: -

Identifier Source: org_study_id