Please select the eligibility criteria that correspond to the clinical trial below.
Title: Multicenter Clinical Study With Early Treatment Intensification In Patients With High- Risk Hodgkin Lymphoma, Identified As FDG-PET Scan Positive After 2 Conventional ABVD Courses
Brief Summary: The purpose of this multicenter clinical trial is to assess the clinical impact of dose intensification performed very early during treatment in a subset of poor prognosis, advanced-stage Hodgkin Lymphoma patients, defined as PET-positive after two courses of conventional adriamycin (doxorubicin), bleomycin, vinblastine and dacarbazine (ABVD) chemotherapy.


Options:
A: 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
B: DISEASE CHARACTERISTICS:

* Histologically confirmed\* Hodgkin lymphoma

  * Clinical stage IA, IB, IIA, or IIB disease according to the modified Ann Arbor Staging Classification system
  * Subclassified according to the WHO modification of the Rye Classification
  * "E" extension allowed provided all other criteria have been met NOTE: \*Pathology materials must be submitted within 60 days of study registration. Core-needle biopsies are acceptable provided they contain adequate tissue for primary diagnosis and immunophenotyping. Fine-needle aspirates not allowed. If multiple specimens are available, submit the most recent.
* No nodular lymphocyte-predominant Hodgkin lymphoma
* No mediastinal mass \> 0.33 maximum intrathoracic diameter by standing postero-anterior chest x-ray or peripheral or retroperitoneal adenopathy \> 10 cm in its largest diameter
* Measurable disease by physical examination or imaging studies

  * Any tumor mass measurable in two dimensions and \> 1 cm (or 1.5 cm if 0.5 cm slices are used, as in spiral CT scans) allowed
  * Lesions that are considered intrinsically non-measurable include:

    * Bone lesions
    * Leptomeningeal disease
    * Ascites
    * Pleural/pericardial effusion
    * Lymphangitis cutis/pulmonis
    * Abdominal masses that are not confirmed and followed by imaging techniques
    * Cystic lesions
    * Lesions that are situated in a previously irradiated area

PATIENT CHARACTERISTICS:

* Performance status 0-2
* ANC ≥ 1,000/μL
* Platelet count ≥ 100,000/μL
* Serum creatinine ≤ 2 mg/dL
* Bilirubin ≤ 2 mg/dL
* AST ≤ 2 times upper limit of normal
* LVEF normal by ECHO or MUGA
* DLCO ≥ 60% with no symptomatic pulmonary disease
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Patients with known HIV allowed provided they have CD4 counts ≥ 350/mcL

  * Patients must not have multi-drug resistant HIV infections (i.e., concurrent AIDS-defining conditions)
  * An HIV test is required for patients with a history of IV drug abuse or any behavior associated with an increased risk of HIVinfection
* No "currently active" second malignancy other than nonmelanoma skin cancers

  * Patients are not considered to have a "currently active" malignancy provided they have completed therapy and are considered by their physician to be at \< 30% risk of relapse

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No prior chemotherapy or radiotherapy for Hodgkin lymphoma

  * 1 course of ABVD (doxorubicin, bleomycin, vinblastine, and dacarbazine) allowed and will be considered the first course
C: Inclusion Criteria:

* Patients with advanced classical Hodgkin Lymphoma according to the World Health Organization classification
* Aged 18-60
* Not previously treated
* Stages IIB to IV B
* All IPS prognostic groups
* Patients who have signed an informed consent form

Exclusion Criteria:

* Patients aged more than 60.
* Concomitant or previously treated neoplastic disorder less than 5 year before the diagnosis of Hodgkin's lymphoma.
* Psychiatric disorders
* Uncontrolled infectious disease
* Impaired cardiac (EF \< 50%) , renal (creatinine clearance \< 60 ml/m)
* HIV, HBV DNA, HCV RNA positive markers
* Pregnancy and lactation
* Patients with uncompensated diabetes mellitus and fasting glucose levels over 200 mg/dl
D: Inclusion Criteria:

* Histologically confirmed Hodgkin's lymphoma of the classical type (nodular lymphocyte predominance excluded).
* Stage IIB-IV.
* Age 18-70.
* No prior therapy for Hodgkin's lymphoma
* Written informed consent.
* ECOG performance status grades 0-3 (see Appendix E).
* FDG-PET scan before the initiation of treatment.

Exclusion Criteria:

* Prior therapy for Hodgkin's lymphoma.
* Age less than 18 or more than 70.
* Other concomitant or prior malignancies, except basal cell skin carcinoma, or adequately treated carcinoma in situ of the cervix, or any cancer in complete remission for more than 5 years.
* HIV infection.
* Pregnancy or breast-feeding.
* Renal failure (creatinine ≥2 times the normal value), liver failure (AST/ALT or bilirubine ≥ 2.5 times the normal value) or heart failure (NYHA class ≥ 2 or FEV \< 45%).

Answer: C