Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized Study of Ruxolitinib Tablets Compared to Best Available Therapy in Subjects With Primary Myelofibrosis, Post-Polycythemia Vera-Myelofibrosis or Post-Essential Thrombocythemia Myelofibrosis
Brief Summary: This was an open label, randomized study comparing the efficacy and safety of randomized 2:1 Ruxolitinib tablets versus best-available therapy, as selected by the investigator. The purpose was to compare the efficacy, safety and tolerability of Ruxolitinib (INC424/INCB018424) given twice daily to the best-available therapy, in subjects with primary myelofibrosis (PMF), post polycythemia vera myelofibrosis (PPV-MF) or post essential thrombocythemia myelofibrosis (PET-MF).


Options:
A: Inclusion Criteria:

* Subjects must be diagnosed with PMF, PPV-MF or PET-MF according to the 2008 World Health Organization criteria
* Subjects with MF requiring therapy must be classified as high risk OR intermediate risk level 2 according to the prognostic factors defined by the International Working Group
* Subjects with an ECOG performance status of 0, 1, 2 or 3
* Subjects with peripheral blood blast count of \< 10%.
* Subjects who have not previously received treatment with a JAK inhibitor

Exclusion Criteria:

* Subjects with a life expectancy of less than 6 months
* Subjects with inadequate bone marrow reserve as demonstrated by specific clinical laboratory counts
* Subjects with any history of platelet counts \< 50,000/µL or ANC \< 500/µL except during treatment for a myeloproliferative disorder or treatment with cytotoxic therapy for any other reason
* Subjects with inadequate liver or renal function
* Subjects with clinically significant bacterial, fungal, parasitic or viral infection which require therapy
* Subjects with an active malignancy over the previous 5 years except specific skin cancers
* Subjects with severe cardiac conditions
* Subjects who have had splenic irradiation within 12 months
B: Inclusion Criteria:

* Diagnosed with PMF, PPV-MF or PET-MF as confirmed by bone marrow biopsy
* Discontinuation of all drugs used to treat underlying MF disease at least 14 days prior to baseline visit
* INR \<= 1.5 or PTT value \< 1.5 x upper limit of normal (ULN) at study entry
* Hemoglobin level at least 6.5 g/dL at Screening visit
* Willingness to be transfused to treat low hemoglobin levels

Exclusion Criteria:

* Females who are pregnant, unable to comply with birth control use to avoid becoming pregnant or breastfeeding
* Males who cannot comply with birth control use to avoid fathering a child
* Platelet count \< 50 x10\^9/L or absolute neutrophil count (ANC) \< 1 x10\^9/L at the Screening visit
* Inadequate liver or renal function; Intracranial bleeds or invasive malignancy over the previous 2 years - international normalized ratio (INR) laboratory values cannot be \> 1.5 x upper limit of normal at study entry.
C: Inclusion Criteria:

* Subjects must be diagnosed with primary myelofibrosis (PMF), post-polycythemia vera-myelofibrosis (PPV-MF) or post-essential thrombocythemia-myelofibrosis (PET-MF) according to the 2008 World Health Organization criteria
* Subjects with myelofibrosis requiring therapy must be classified as high risk OR intermediate risk level 2 according to the prognostic factors defined by the International Working Group
* Subjects with an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, 2 or 3
* Subjects who have not previously received treatment with a Janus kinase (JAK) inhibitor

Exclusion Criteria:

* Subjects with a life expectancy of less than 6 months
* Subjects with inadequate bone marrow reserve as demonstrated by specific clinical laboratory counts
* Subjects with inadequate liver or renal function
* Subjects with clinically significant bacterial, fungal, parasitic or viral infection which require therapy
* Subjects with an active malignancy over the previous 5 years except specific skin cancers.
* Subjects with severe cardiac conditions
* Subjects who have had splenic irradiation within 12 months
D: Inclusion Criteria:

1. Diagnosis of myelofibrosis requiring therapy, including those previously treated and relapsed or refractory, or if newly diagnosed, with intermediate or high risk according to Lille scoring system (risk factors are: Hb \< 10 g/dl, White blood count (WBC) \< 4 or \> 30 x 109/L; risk group: 0 factor(s) = low, 1 factor(s) = intermediate, 2 factor(s) = high) or with symptomatic splenomegaly
2. Understanding and voluntary signing an Institutional Review Board (IRB)-approved informed consent form.
3. Age \>/= 18 years at the time of signing the informed consent.
4. Disease-free of prior malignancies for \>/= 2-years with exception of basal cell or squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast.
5. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
6. Patients must have adequate organ function as demonstrated by the following: Total bilirubin \</= 2.0 mg/dL (unless higher due to MF); Serum creatinine \</= 2.0 mg/dL (unless higher due to MF); Absolute neutrophil count \>/= 1 x 10\^9/L; Alanine transaminase (ALT) \</= 3 x upper limit of normal (unless higher due to MF).
7. Females of childbearing potential (FCBP)† must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior to and again within 24 hours of starting lenalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 4 weeks before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing.
8. Continuation of 7. Men must agree to use a condom during sexual contact with a female of child bearing potential even if they have had a successful vasectomy. All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure. See Appendix J: Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods
9. footnote to no 7. † A female of childbearing potential is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
10. All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®.

Exclusion Criteria:

1. Use of any other standard (e.g. hydroxyurea, anagrelide, growth factors) or experimental drug or therapy within 28 days of starting lenalidomide and/or lack of recovery from all toxicity from previous therapy to grade 1 or better.
2. Known prior clinically relevant hypersensitivity reaction to thalidomide, including the development of erythema nodosum if characterized by a desquamating rash.
3. Prior therapy with lenalidomide.
4. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
5. Suspected Pregnancy. Pregnant or lactating females.
6. Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
7. Known positive for HIV or infectious hepatitis, type A, B or C.
8. Known prior clinically relevant hypersensitivity to prednisone.
9. Participants with a heart rate (HR) of less than or equal to 50, as a HR less than 50 indicates underlying cardiac abnormalities.
10. Participants with prior history of thromboembolic disease (i.e.-deep venous thrombosis (DVT) or pulmonary embolism (PE)) within the last six months, as Lenalidomide has demonstrated a significantly increased risk of DVT or PE.

Answer: A