Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase II Study of Azacitidine (Vidaza®) Combined to Epoetin Beta (NeoRecormon®) in IPSS Low-risk and Intermediate-1 MDS Patients, Resistant to ESA
Brief Summary: The study is aimed to treat low-risk MDS patients,who are dependent on red-blood cell transfusion due to disease-related anemia, and who have a proven resistance towards treatment with erythropoetin-stimulating agents (ESA). The study randomizes patients to receive a treatment with the demethylating agent 5-azacytidine alone or in combination with an ESA. The study thus evaluates, if efficacy of 5-azacytidine, notably on the red-blood cell transfusion-dependence is comparable/inferior to a combination treatment with azacitidine and an ESA (that is if 5-azacytidine can overcome the resistance towards ESA). Being a phase II study, the study assesses, duration of erythroid response, overall survival and time to progression as well as toxicity.


Options:
A: Inclusion Criteria:

MDS defined as

* RCMD, RA with or without ring sideroblasts
* RAEB 1, or CMML 1, if WBC \< 13 G /l according to the WHO classification
* with a low or int-1 IPSS score AND
* primary or secondary resistance to epoetin alpha/ beta (\> 60000 U/w) or darbepoetin (\> 250ug/w), administered for at least 12 weeks
* requirement of RBC transfusions \> 4 U in the previous 8 weeks
* Aged 18 years or more
* Adequate contraception, if relevant
* Negative pregnancy test if relevant
* Written Informed consent
* Ability to participate to a clinical trial and adhere to study procedures
* Health insurance

Exclusion Criteria:

* Therapy-related MDS (after chemo- or radiotherapy for a previous neoplasm or immune disorder)
* Patients with a planned allogeneic bone marrow transplantation
* Creatininemia \>1.5 upper normal value or estimated Ccr less than 30ml/mn
* ALAT and ASAT \>2.5 upper normal value
* Bilirubin \>2N, except unconjugated hyperbilirubinemia due to MDS-related dyserythropoiesis
* Heart failure NYHA \> II
* Known allergy to mannitol
* Other tumor, unstable for the last three years, except in situ uterine carcinoma or basal skin tumor
* ECOG \> 2
* Life expectancy less than 3 months
B: Inclusion Criteria:

* Aged 18 years or older;
* Had histologically, cytologically or clinically diagnosed malignant tumour and measurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1;
* Undergoing adjuvant or palliative chemotherapy with an expected survival of at least 3 months;
* Inadequately responsive or unresponsive to routine dosages of EPO treatment. Inadequate responders or nonresponders are defined as those CIA patients with an increase of Hb \< 1g/dL after 4 weeks of treatment with 10, 000 IU of EPO, three times weekly by subcutaneous injection).
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2;
* Are compliant and can understand the research and sign an informed consent form.

Exclusion Criteria:

* History of thromboembolism in the previous twelve months;
* Family history of hemochromatosis;
* Anaemia diagnosed with myelodysplastic syndrome or hematologic diseases such as Mediterranean anaemia;
* Received EPO treatment in the prior three months;
* Received erythrocyte suspension transfusion in the prior two weeks;
* Women who are pregnant or lactating;
* Have a history of hypertension or mental illness.
C: Inclusion Criteria:

* subjects with non-myeloid malignancies
* anemia due to cancer
* ECOG status 0 to 2
* greater than or equal to 4-month expectancy
* greater than or equal to 18 years and of legal age for informed consent
* screening hemoglobin concentration less than or equal to 11.0g/dL
* adequate serum folate and vitamin B12
* adequate renal and liver function
* written informed consent

Exclusion Criteria:

* subjects currently receiving or planned to receive cytotoxic chemotherapy or myelosuppressive radiotherapy during the study or within 4 weeks before randomization
* in complete remission, as determined by the investigator
* subjects who have other diagnoses not related to the cancer which cause anemia (eg. gastrointestinal bleeding, renal disease, etc)
* documented history of pure red cell aplasia
* Known history of seizure disorder
* cardiac condition: uncontrolled angina, congestive heart failure, known ejection fraction less than 40%, or uncontrolled cardiac arrhythmia
* uncontrolled hypertension
* clinically significant systemic infection or chronic inflammatory disease present at the time of randomization
* iron deficiency
* known positive test for HIV infection
* previously suspected of or confirmed to have neutralizing antibodies to rHuEPO or darbepoetin alfa
* received rHuEPO or darbepoetin alfa therapy within 4 weeks of randomization
* less than 30 days since receipt of any investigational drug or device that is not approved by the applicable regulatory authority
* pregnant or breast feeding
* subject of reproductive potential who is not using adequate contraceptive precautions
* known hypersensitivity to mammalian-derived product or any other ingredients in the investigational product
* previously randomized into this study
* concerns for subject's compliance with the protocol procedures
D: Inclusion Criteria:

* Age 20-70 years
* Good performance status (Zubrod score \< 2)
* No serious underlying disease
* Normal renal function test
* Normal liver function test
* Platinum based chemotherapy is the first line regimen
* No prior or receiving radiotherapy

Exclusion Criteria:

* Iron hypersensitivity
* Underlying disease which has the risk of iron overload such as chronic kidney disease, major thalassemia
* Progressive disease
* Bone marrow metastasis

Answer: A