Study of a Treatment Driven by Early PET Response to a Treatment Not Monitored by Early PET in Patients With AA Stage 3-4 or 2B HL

Centre Hospitalier Universitaire Dijon

Overview

All study treatments have proven efficacy in the treatment in Hodgkin lymphoma (HL). It is hoped that patients will achieve a good response to both induction therapies consisting either of 4 cycles of BEACOPPesc (Bleomycin, Etoposide, Doxorubicin, Cyclophosphamide, Vincristine, Procarbazine, and Prednisone) or 2 cycles of BEACOPPesc plus 2 cycles of ABVD (Adriamycine, Bléomycine, Vinblastine, Décarbazine). The use of F-FDG Position Emission Tomography performed after 2 cycles of chemotherapy (PET2) in the experimental arm will help to stratify patients in order to restrict the BEACOPPesc therapy continuation to those patients who achieved only a partial response after 2 BEACOPPesc regimen and to allow a conventional dose ABVD chemotherapy strategy for PET2 negative patients. For all patients included in the trial the achievement of a good response to induction treatment will be checked after four cycles of induction treatment including a centrally reviewed PET assessment Patients will be randomized after verification of eligibility and before the start of the protocol treatment.Patients will be randomly assigned to the standard treatment arm not monitored by early PET, or the experimental treatment arm driven by the PET2 result.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Conditions

Hodgkin's Lymphoma

Interventions

Eligibility

Sex: ALLMin age: 16 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient with a first diagnosis of classical Hodgkin lymphoma according to world health organization (WHO) criteria excluding nodular lymphocyte predominant subtype * Age of 16 to 60 years * No previous treatment for Hodgkin lymphoma * Ann Arbor stages: IIB with mediastinum/thorax ≥0.33 or extra nodal localization III IV * Baseline 18-FDG PET scan (PET0)(F-FDG Positon Emission Tomography) performed before any treatment with at least one hypermetabolic lesion * Eastern Cooperative Oncology Group (ECOG) performance status \< 3 * With a minimum life expectancy of 3 months * Having previously signed a written informed consent * The patient must be covered by a social security system (in France) Exclusion Criteria: * Pregnant or lactating women * Men and women of childbearing potential not practicing an adequate method of contraception during the study treatment and at least 3 months after the last study drug administration * Any history of cancer or cancer treatment during the last 5 years with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma * Uncontrolled infectious disease, including active HBV (hepatitis B virus) infection defined by either detection of HBs Antigen or presence of anti HBs antibody without detectable anti HBc antibody. * HIV (Human immunodeficiency virus), HCV (hepatitis C virus) or HTLV (Human T-lymphotropic virus) serology positivity * Abnormal liver (bilirubin \> 2,5 N) function unless abnormalities are due to AHL 2011 Protocol Version n°1.2\_ 09/02/11\_approved on March 11, 2011 EudraCT n°2010-022844-19 4 / 73 Hodgkin lymphoma * Abnormal renal (Creatinin \> 150 μmol/L) function unless abnormalities are due to Hodgkin lymphoma * Leukopenia \< 2 G/l or thrombopenia \<100 G/l unless abnormalities are due to Hodgkin lymphoma * Severe cardio-pulmonary, or metabolic disease interfering with normal application of protocol treatment: * Left Ejection Ventricular Fraction \<50% * Respiratory insufficiency prohibiting bleomycin use * Uncontrolled diabetes mellitus leading to impossibility to perform PET scan * Impossibility to perform a baseline PET (PET0) before randomization and treatment beginning * Incapable person

Locations (96)

ZNA Stuivenberg

Antwerp, Belgium

Clinique sud Luxembourg

Arlon, Belgium

RHMS

Baudour, Belgium

Az Sint Jan

Bruges, Belgium

Hôpital Erasme

Brussels, Belgium

Ucl Bruxelles

Brussels, Belgium

Outcomes

Primary Outcomes

Progression free survival

Evaluate by PFS at 5 years the non-inferiority of a chemotherapy of a therapeutic strategy driven by PET with a ABVD conventional dose chemotherapy for patients reaching a negative PET after 2 cycles of BEACOPPesc, compared to a treatment not monitored by early PET delivering 6 cycles of BEACOPPesc.

Time frame: 5 years