Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of SGN-35 and Best Supportive Care (BSC) Versus Placebo and BSC in the Treatment of Patients at High Risk of Residual Hodgkin Lymphoma Following Autologous Stem Cell Transplant
Brief Summary: This is a randomized, double-blind, placebo-controlled, multicenter phase 3 trial to evaluate the efficacy and safety of brentuximab vedotin (SGN-35) and best supportive care (BSC) compared to placebo and BSC in treatment of residual Hodgkin lymphoma (HL) following autologous stem cell transplant (ASCT).


Options:
A: 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
B: Inclusion Criteria:

* Hodgkin Lymphoma (histologically proven)
* CS (PS) IIB with one or both of the risk factors:

  * bulky mediastinal mass (\> 1/3 of maximum transverse thorax diameter)
  * extranodal involvement
* CS (PS) III, IV
* Written informed consent

Exclusion Criteria:

* Leucocytes \< 3000/µl
* Platelets \< 100000/µl
* Hodgkin´s lymphoma as "composite lymphoma"
* Activity index (WHO) \< grade 2
C: 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%).
D: 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

Answer: D