Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Single-arm, International, Multi-center Trial of HuMax-CD20, a Fully Human Monoclonal Anti-CD20 Antibody, in Patients With B-cell Chronic Lymphocytic Leukemia Who Have Failed Fludarabine and Alemtuzumab
Brief Summary: The purpose of this study is to determine whether HuMax-CD20 (ofatumumab) is effective in the treatment of patients failing both fludarabine and alemtuzumab.


Options:
A: Inclusion Criteria:

1. Tumor cell phenotype consistent with B-CLL
2. Patients with active B-CLL and with an indication for treatment
3. Failing at least one fludarabine-containing treatment regimen
4. Failing at least one alemtuzumab-containing treatment regimen
5. ECOG Performance Status of 0, 1, or 2
6. Life expectancy of at least 4 months

Exclusion Criteria:

1. Previous treatment with alemtuzumab within 6 weeks prior to Visit 2
2. Previous autologous stem cell transplantation within 6 months prior to Visit 2
3. Allogeneic stem cell transplantation
4. Radioimmunotherapy
B: Inclusion criteria

* B-CLL
* Matutes score 4 or 5
* Binet stages B or C
* Age \> 65 years old
* No previous treatment of CLL by chemotherapy, radiotherapy or immunotherapy, except glucocorticoids \< 1 month
* Patient's written informed consent
* Life expectancy \> 6 months

Exclusion criteria

* Binet stage A
* ECOG performance status 2 or more
* Presence of a 17p deletion by FISH (\> 10% positive cores)
* Clinically significant auto-immune cytopenia, Coombs-positive hemolytic anemia as judged by the treating physician
* Patients with a history of another malignancy in complete remission less than 5 years, except basal cell skin cancer or tumor treated curatively by surgery
* Concomitant disease requiring prolonged use of corticosteroids (\> 1 month)
* Any severe co-morbidities such as NYHA Class III or IV heart failure, myocardial infarction within 6 months, unstable angina, ventricular tachyarrhythmias requiring ongoing treatment, severe uncontrolled myocardiopathy, uncontrolled hypertension, severe chronic obstructive pulmonary disease with hypoxemia, or uncontrolled diabetes mellitus.
* CIRS (Cumulative Illness rating Scale) \> 6
* Known hypersensitivity to murine proteins or to any of the study drugs or to their components
* Transformation into an aggressive B-cell malignancy (e.g. diffuse large cell lymphoma, Hodgkin lymphoma) or prolymphocytic leukemia
* Active bacterial, viral or fungal infection
* Seropositivity HIV, hepatitis C or hepatitis B (unless clearly due to vaccination)
* Total bilirubin, alkaline phosphatases and aminotransferases \> 2 x ULN
* Creatinine clearance \< 60 ml/min calculated according to the formula of Cockcroft and Gault
* Any coexisting medical or psychological condition that would preclude participation to the required study procedures
* Patient with mental deficiency preventing proper understanding of the requirements of treatment

Inclusion criteria at randomization

* Patients having received the full induction phase with 4 FC and 6 rituximab courses (with/without dose adjustments as per protocol)
* Complete or partial response according to NCI and iwCLL criteria at the end of induction phase
* Recovery from FCR toxicities
* Patient willingness to continue on protocol
C: Inclusion:

* Adult subjects with previously treated recurrent CLL who have measurable lymphadenopathy
* Require therapy for CLL
* Have experienced CLL progression \< 24 months since the completion of the last prior therapy
* Currently not sufficiently fit to receive cytotoxic therapy because of chemotherapy-induced bone marrow damage or comorbidities.
D: Inclusion Criteria:

* documented chronic lymphocytic leukemia (CLL) requiring treatment according to International Working Group on CLL (iwCLL) criteria
* adequate hematologic function: platelets ≥ 25.000/µl, neutrophils ≥ 1.000/µl and hemoglobin ≥8.0 g/dL, unless directly attributable to the patient´s CLL (e.g. bone marrow infiltration)
* adequate renal function: a creatinine clearance ≥30ml/min calculated according to the modified formula of Cockcroft and Gault or directly measured with 24 hr. urine collection
* adequate liver function: total bilirubin ≤1,5x, aspartate aminotransferase (AST) / alanin aminotransferase (ALT) ≤2.5x the institutional upper limit of normal (ULN) value, unless directly attributable to the patient's CLL or to Gilbert's Syndrome
* negative serological testing for hepatitis B, negative testing for hepatitis-C RNA and negative HIV test within 6 weeks prior to registration
* age ≥ 18 years
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2, ECOG 3 is only permitted if related to CLL
* life expectancy ≥ 6 months
* ability and willingness to provide written informed consent and to adhere to the study visit schedule and other protocol requirements

Exclusion Criteria:

* transformation of CLL (i.e. Richter's transformation, prolymphocytic leukemia)
* known central nervous system (CNS) involvement
* confirmed progressive multifocal leukoencephalopathy (PML)
* malignancies other than CLL currently requiring systemic therapies
* uncontrolled infection requiring systemic treatment
* any comorbidity or organ system impairment rated with a cumulative illness rating scale (CIRS) score of 4, excluding the eyes/ears/nose/throat/larynx organ system or any other life-threatening illness, medical condition or organ system dysfunction that - in the investigator´s opinion - could compromise the patients safety or interfere with the absorption or metabolism of the study drugs (e.g, inability to swallow tablets or impaired resorption in the gastrointestinal tract)
* ongoing inflammatory bowel disease
* ongoing drug induced pneumonitis
* use of investigational agents which would interfere with the study drug ≤28 days prior to registration
* known hypersensitivity to GA101 (obinutuzumab), CAL-101 (idelalisib) or any of the excipients
* pregnant women and nursing mothers
* fertile men or women of childbearing potential unless surgically sterile or ≥ 2 years after the onset of menopause, or willing to use two methods of reliable contraception including one highly effective (Pearl Index \<1) and one additional effective (barrier) method during study treatment and for 18 months after end of study treatment
* vaccination with a live vaccine ≤28 days prior to registration
* legal incapacity
* prisoners or subjects who are institutionalized by regulatory or court order
* persons who are in dependence to the sponsor or an investigator

Answer: A