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

European Organisation for Research and Treatment of Cancer (EORTC)

Status and phase: Withdrawn; Phase 3

Conditions: Hodgkin Lymphoma

Treatments: Drug: BEACOPPesc; Drug: ABVD + FDG-PET/CT Scan treatment adaptation

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT01652261

EORTC-20101-23101

2011-005473-22 (EudraCT Number)

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 60 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

experimental arm

Experimental group

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)).

Treatment:

Drug: ABVD + FDG-PET/CT Scan treatment adaptation

Drug: BEACOPPesc

standard arm

Active Comparator group

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)).

Treatment:

Drug: BEACOPPesc