Please select the eligibility criteria that correspond to the clinical trial below.
Title: Phase II Trial of Doxorubicin, Vinblastine, and Gemcitabine (AVG) Chemotherapy for Non-Bulky Stage I and II Hodgkin's Lymphoma
Brief Summary: RATIONALE: Drugs used in chemotherapy, such as doxorubicin, vinblastine, and gemcitabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.

PURPOSE: This phase II trial is studying how well combination chemotherapy works in treating patients with newly diagnosed stage I or stage II Hodgkin's lymphoma.


Options:
A: Inclusion Criteria:

* Patients with HL who have received ASCT in the previous 30-45 days
* Patients at high risk of residual HL post ASCT
* Histologically-confirmed HL
* ECOG of 0 or 1
* Adequate organ function

Exclusion Criteria:

* Previous treatment with brentuximab vedotin
* Previously received an allogeneic transplant
* Patients who were determined to have a best clinical response of progressive disease with salvage treatment immediately prior to ASCT
* History of another primary malignancy that has not been in remission for at least 3 years
* Post ASCT or current therapy with other systemic anti-neoplastic or investigational agents
B: DISEASE CHARACTERISTICS:

* Histologically confirmed Hodgkin's lymphoma

  * No nodular lymphocyte-predominant subtype (nodular paragranuloma)
* Supradiaphragmatic Ann Arbor clinical stage I or II disease
* Must meet criteria for 1 of the following prognostic subsets:

  * Unfavorable subset, defined as meeting 1 of the following criteria:

    * Clinical stage II disease with ≥ 4 nodal areas involved

      * Mediastinum and hili are considered as 1 nodal area
    * Age ≥ 50 years
    * Erythrocyte sedimentation rate (ESR) ≥ 50 mm/hr with no B symptoms
    * ESR ≥ 30 mm/hr with B symptoms
    * Mediastinum/thoracic (MT) ratio ≥ 0.35
  * Favorable subset, defined as meeting all of the following criteria:

    * Clinical stage I disease OR stage II disease with ≤ 3 involved areas
    * Age \< 50 years
    * ESR \< 50 mm/hr (no B symptoms) OR ESR \< 30 mm/hr (B symptoms present)
    * MT ratio \< 0.35
* Previously untreated disease
* Planning to undergo fludeoxyglucose F 18 positron emission tomography after the first 2 courses of study chemotherapy

PATIENT CHARACTERISTICS:

* WHO performance status 0-3
* Bilirubin ≤ 2.5 times upper limit of normal (ULN)
* Creatinine ≤ 2.5 times ULN
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No severe cardiac, pulmonary, neurologic, psychiatric, or metabolic disease
* No unstable diabetes mellitus
* No other malignancies within the past 5 years except for basal cell skin cancer or adequately treated carcinoma in situ of the cervix
* No known HIV infection
* No psychological, familial, sociological, or geographical condition that would preclude study compliance

PRIOR CONCURRENT THERAPY:

* Not specified
C: 1. Documentation of Disease:

   1.1 Histologically documented Hodgkin lymphoma subclassified according to the WHO modification of the Rye Classification and staged according to the modified Ann Arbor Staging Classification system. Patients must have clinical stage IA, IB, IIA or IIB. Patients with "E" extensions will be eligible if all other criteria have been met. Nodular lymphocyte predominant Hodgkin lymphoma is excluded.
   * Core biopsies are acceptable if they contain adequate tissue for primary diagnosis and immunophenotyping. Fine needle aspirate (FNA) cytologies and bone marrow biopsies as the sole means of diagnosis are not acceptable.
   * Note: Failure to submit pathology slides within 60 days of patient registration will result in patient being declared ineligible.

   1.2 Patients may not have a mediastinal mass \> 0.33 maximum intrathoracic diameter on standing postero-anterior chest x-ray or peripheral or retroperitoneal adenopathy \> 10 cm in its largest diameter.

   1.3 Bone marrow biopsy is required for pretreatment evaluation. Bilateral biopsies are preferred but not required.
2. No prior treatment (chemotherapy or radiation therapy) for Hodgkin lymphoma.
3. Measurable disease must be present either on physical examination or imaging studies. Any tumor mass measurable in two dimensions and \> 2 cm is acceptable (or 1.5 cm if 0.5 cm slices are used as in spiral CT scans). Lesions that are considered intrinsically non-measurable include the following:

   * bone lesions
   * leptomeningeal disease
   * ascites
   * pleural/pericardial effusion
   * inflammatory breast disease
   * 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
4. Age ≥ 16 years
5. Performance status 0-2
6. LVEF by ECHO or MUGA within institutional normal limits
7. DLCO ≥ 60% with no symptomatic pulmonary disease
8. No known HIV infection. Patients with a history of intravenous drug abuse or any behavior associated with an increased risk of HIV infection should be tested for exposure to the HIV virus. Patients who test positive or who are known to be infected are not eligible due to an increased risk of infection with this chemotherapy regimen. An HIV test is not required for entry on this protocol, but is required if the patient is perceived to be at risk.
9. Non-pregnant and non-lactating. Due to the teratogenic potential of the agents used in this study, pregnant or nursing women may not be enrolled. Women and men of reproductive potential should agree to use an effective means of birth control.
10. Initial Required Laboratory Data:

    * ANC ≥ 1000/μL
    * Platelet count ≥ 100,000/μL
    * Serum Creatinine ≤ 2 mg/dL
    * Bilirubin ≤ 2 mg/dL
    * AST ≤ 2 x upper limit of normal
D: 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

Answer: C