Study of a Treatment Driven by Early PET Response to a Tr... | NCT01358747

Status Module

Name	Class
The Lymphoma Study Association	UNKNOWN

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Standard arm	Active Comparator	Induction treatment: Patients will be treated by a BEACOPPesc regimen every 3 weeks for 4 cycles. A PET will be performed after 2 cycles of chemotherapy (PET2) with no decisional value, and after 4 cycles with decisional value. Consolidation treatment: depends on the reviewed PET4 result. In case of PET4 negative result, patient will received 2 additional cycles of BEACOPPesc, whatever the result of the PET2. In case of PET4 positive, the patient will be considered in treatment failure and proposed to a salvage therapy after pathologic confirmation of failure by biopsy of the hypermetabolic residual mass when possible.	Drug: BEACOPPesc
Experimental arm	Experimental	Induction treatment: Patients will be treated by a BEACOPPesc regimen every 3 weeks for 2 cycles followed by a PET scan (PET2). After PET2 central review: In case of positive PET2, the induction treatment will be completed by 2 additional cycles of BEACOPPesc In case of negative PET2, the induction treatment will be completed by 2 cycles of ABVD delivered every 4 weeks. The first cycle of ABVD will start at day 21 of the second cycle of BEACOPPesc. Consolidation treatment: depends on the reviewed PET4 result In case of PET4 negative result, consolidation treatment will depends on PET2 results: If PET2 was positive, patient will received 2 additional cycles of BEACOPPesc delivered every 3 weeks If PET2 was negative, patient will received 2 additional cycles of ABVD delivered every 4 weeks In case of PET4 positive, the patient will be considered as treatment failure.	Drug: BEACOPPesc - ABVD - PET2

Name	Type	Description	Arm Group Labels	Other Names
BEACOPPesc	Drug		Standard arm
BEACOPPesc - ABVD - PET2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	5 years

Eligibility Module

Eligibility Criteria

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

Name	Affiliation	Role
René-Olivier CASASNOVAS, MD	CHU Dijon	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
ZNA Stuivenberg		Antwerp		2060	Belgium
Clinique sud Luxembourg

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30658935	Result	Casasnovas RO, Bouabdallah R, Brice P, Lazarovici J, Ghesquieres H, Stamatoullas A, Dupuis J, Gac AC, Gastinne T, Joly B, Bouabdallah K, Nicolas-Virelizier E, Feugier P, Morschhauser F, Delarue R, Farhat H, Quittet P, Berriolo-Riedinger A, Tempescul A, Edeline V, Maisonneuve H, Fornecker LM, Lamy T, Delmer A, Dartigues P, Martin L, Andre M, Mounier N, Traverse-Glehen A, Meignan M. PET-adapted treatment for newly diagnosed advanced Hodgkin lymphoma (AHL2011): a randomised, multicentre, non-inferiority, phase 3 study. Lancet Oncol. 2019 Feb;20(2):202-215. doi: 10.1016/S1470-2045(18)30784-8. Epub 2019 Jan 15.
40135712

ID	Term
D008223	Lymphoma
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases
D006425	Hemic and Lymphatic Diseases
D007160	Immunoproliferative Disorders
D007154	Immune System Diseases