Tissue Collection for Correlation Between ATM Alterations by Next-Generation Sequencing and ATM Loss-of-Protein

Exclusion Criteria

• •Group C patients who meet any of the following criteria will be excluded from study entry:
• •1. Have a significant bleeding disorder or vasculitis or had a Grade 3 bleeding episode within 12 weeks prior to enrollment.
• •2. Presumed ineligible for enrollment to REFMAL 721/ART0380C001:
• •* Psychological, familial, sociological, or geographical conditions that that would compromise the patient's ability to adhere to future procedures likely in a Phase I protocol (such as REFMAL 721/ ART0380C001).
• •* Women who are pregnant, breast feeding, or who plan to become pregnant within the next 6 months.
• •* Men who plan to father a child within the next 6 months.
• •* Have a serious concomitant systemic disorder that would compromise the patient's ability to adhere to a future protocol (REFMAL 721/ ART0380C001) including:
• •1. One or more opportunistic HIV/AIDs-related infections within the past 12 months.
• •2. Documented active or chronic infection with hepatitis B virus (positive hepatitis B surface antigen \[+HBsAg\]), or hepatitis C virus.
• •3. Known history of clinical diagnosis of tuberculosis.
• •4. Have had a malignancy prior to the current malignancy. Patients with carcinoma in situ of any origin and patients with prior malignancies who are in remission and whose likelihood of recurrence is very low (such as basal cell carcinoma), as judged by the medical monitor, are eligible for this study.
• •* Have evidence of interstitial lung disease or pneumonitis (whether symptomatic or asymptomatic).
• •* Have moderate or severe cardiovascular disease, such as the following:
• •1. Have the presence of cardiac disease.
• •2. Have valvulopathy that is severe, moderate, or deemed clinically significant.
• •3. Have documented major electrocardiogram (ECG) abnormalities which are clinically significant.
• •* Have symptomatic or uncontrolled brain metastases, spinal cord compression, or leptomeningeal disease requiring concurrent treatment, including but not limited to surgery, radiation, and/or corticosteroids (patients receiving anticonvulsants are eligible).