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Randomized Phase III Study of a Treatment Driven by Early PET Response Compared to a Treatment Not Monitored by Early PET in Patients With Ann Arbor Stage III-IV or High Risk IIB Hodgkin Lymphoma


Phase 3
16 Years
60 Years
Open (Enrolling)
Both
Hodgkin's Lymphoma

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Trial Information

Randomized Phase III Study of a Treatment Driven by Early PET Response Compared to a Treatment Not Monitored by Early PET in Patients With Ann Arbor Stage III-IV or High Risk IIB Hodgkin Lymphoma


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment

Outcome Measure:

Progression free survival

Outcome Description:

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.

Outcome Time Frame:

5 years

Safety Issue:

Yes

Principal Investigator

René-Olivier CASASNOVAS, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

CHU Dijon

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

Casasnovas PHRC N 2010

NCT ID:

NCT01358747

Start Date:

May 2011

Completion Date:

Related Keywords:

  • Hodgkin's Lymphoma
  • Hodgkin Disease
  • Lymphoma

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