N1087 Eligibility Checklist MK2206, Bendamustine Hydrochloride, and Rituximab in Treating Patients With Relapsed Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Source Form: NCI FormBuilder:

  1. 9/19/12 9/19/12 -
  2. 8/4/15 8/4/15 - Martin Dugas
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August 4, 2015

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Eligibility CLL N1087 NCT01369849

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  1. StudyEvent: N1087 Eligibility Checklist
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Required Characteristics
18 Years and older
Diagnosis of CLL according to the NCI criteria (Cheson, Bennett et al. 1996) (Hallek 2008) or SLL according to the WHO criteria (Harris, 1999). This includes previous documentation of: - Biopsy-proven small lymphocytic lymphoma (Harris, 1999) or - Diagnosis of CLL according to NCI working group criteria (Cheson, 1996 and Hallek 2008) as evidenced by all of the following: - Peripheral blood B cell count of >5 x 109/L consisting of small to moderate size lymphocytes - Immunophenotyping consistent with CLL defined as: o The predominant population of lymphocytes share both B-cell antigens [CD19, CD20 (typically dim expression), or CD23] as well as CD5 in the absence of other pan-T-cell markers (CD3, CD2, etc.) o Clonality as evidenced by kappa or lambda; light chain expression (typically dim immunoglobulin expression) or other genetic method (e.g. IGHV analysis) NOTE: Splenomegaly, hepatomegaly, or lymphadenopathy are not required for the diagnosis of CLL. - Before diagnosing CLL or SLL, mantle cell lymphoma must be excluded by demonstrating a negative FISH analysis for t(11;14)(IgH/CCND1) on peripheral blood or tissue biopsy or negative immunohistochemical stains for cyclin D1 on involved tissue biopsy
Demonstrated progression after one or two prior lines of CLL therapy (Note: Rituximab monotherapy does not count as a prior line of therapy)
Progressive disease with any one of the following characteristics based on standard criteria for treatment as defined by the NCI-WG 1996 (Cheson, 1996 and Hallek, 2008). 1. Symptomatic CLL characterized by any one of the following: a. Weight loss >=10% within the previous 6 months b. Extreme fatigue attributed to CLL c. Fevers >100.5 F for 2 weeks without evidence of infection d. Drenching night sweats without evidence of infection 2. Evidence of progressive bone marrow failure with hemoglobin <11 g/dL or platelet count <100 x 109/L 3. Massive or rapidly progressive splenomegaly (>6 cm below left costal margin) 4. Massive (>10 cm) or rapidly progressive lymphadenopathy
Life expectancy >=12 months
ECOG performance status (PS) 0, 1, or 2
ECOG Performance Status
The following laboratory values obtained <= 14 days prior to registration
Total bilirubin <=1.5 x Institutional Upper Limit of Normal (ULN) unless due to Gilbert's disease. If total bilirubin is >1.5 x ULN, a direct bilirubin should be performed and must be <1.5 mg/dL for Gilbert's disease to be diagnosed
Is total bilirubin >1.5 x ULN (This question may be answered yes or no)
SGOT (AST) <=2.5 x ULN
SGPT (ALT) <=2.5 X ULN
Creatinine <=1.5 x ULN OR creatinine clearance >=60 mL/min/1.73 m2 for patients with creatinine levels >1.5 x ULN
Is Creatinine >1.5 x ULN (This question may be answered yes or no.)
Adequate bone marrow function as defined by:-A non-transfused platelet count >=30 X 109/L-Neutrophil count (ANC) >=1 X 109/L-Hemoglobin (Hgb) >=8g/dL (Note: Cytopenias due to bone marrow failure are common in patients with relapsed CLL requiring treatment. Accordingly, normal bone marrow function is NOT required for participation)
Negative pregnancy test done <=7 days prior to registration, for women of childbearing potential only.
Ability to complete patient diaries and questionnaire(s) by themselves or with assistance
Provide informed written consent
Willing to return to NCCTG enrolling institution for follow-up
Willing to provide blood samples for correlative research purposes (see Sections 6.31 and 14.11)
Willing to provide bone marrow aspirate for correlative research purposes (see Sections 6.31 and 14.11)
Able to swallow whole tablets (NOTE: Nasogastric or G tube administration is not allowed. Tablets must not be crushed or chewed.)
Exclusion Criteria - All Responses In Section Below Must Be "no."
Prior treatment with bendamustine
Prior treatment with any experimental Akt inhibitors
More than 1 previous purine nucleoside based-therapy (i.e., fludarabine, pentostatin, cladribine)
More than 1 previous alkylating agent based-therapy (i.e. cyclophosphamide, chlorambucil)
More than 2 total prior lines of therapy for CLL
Primary refractory disease as defined by progression while receiving or within 6 months of completion of a chemoimmunotherapy regimen such as fludarabine, cyclophosphamide and rituximab (FCR) or pentostatin, cyclophosphamide and rituximab (PCR)
Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown. - Pregnant women - Nursing women - Men or women of childbearing potential who are unwilling to employ adequate contraception
Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens. Including but not limited to the following: - New York Heart Association Class III or IV heart disease - Recent myocardial infarction (<1 month) - Uncontrolled infection - Known infection with the human immunodeficiency virus (HIV/AIDS) and/or patients taking HAART as further severe immunosuppression with this regimen may occur. - Infection with known chronic, active Hepatitis C - Positive serology for Hepatitis B (HB) defined as a positive test for HBsAg. In addition, if negative for HBsAg but HBcAb positive (regardless of HBsAb status), a HB DNA test will be performed and if positive the subject will be excluded. - Uncontrolled diabetes defined as HbA1c >=8 or fasting blood glucose >=140 mg/dL
Any of the following: - History of significant ventricular arrhythmia in the last 5 years including: ventricular tachycardia or ventricular fibrillation - QTc prolongation on baseline ECG (defined as a QTc interval >450 msec for males and QTc interval >470 msec for females - Currently using a medication known to cause prolonged QTc (See Appendix III) which can not be discontinued Note: Other medications with possible risk of prolonged QTc are allowed but should be used with caution. Patients using these medications should be monitored accordingly. See Appendix IV. - Ventricular arrhythmia on baseline ECG (ventricular tachycardia or ventricular fibrillation >= 3 beats in a row). - Second or third degree heart block (NOTE: Because QTc prolongation has been reported in patients taking MK-2206, individuals with the above characteristics may not be enrolled in this study.)
Receiving any other investigational agent concurrently which would be considered as a treatment for the primary neoplasm
Other active primary malignancy requiring treatment or limits survival to <24 months
Any major surgery <=28 days prior to registration
Any radiation therapy <=4 weeks prior to registration
Current use of corticosteroids (EXCEPTION: Low doses of steroids <10 mg of prednisone or equivalent dose of other steroid used for treatment of non-hematologic medical conditions. NOTE: Previous use of corticosteroids is allowed.)
Active hemolytic anemia requiring immunosuppressive therapy or other pharmacologic treatment (NOTE: Patients who have a positive Coombs test but no evidence of hemolysis are NOT excluded from participation.)
Receiving any medications or substances that are strong or moderate inhibitors or inducers of CYP450 3A4. - Use of the following strong or moderate inhibitors are prohibited <=7 days prior to registration: Strong Inhibitors of CYP3A4: o Indinavir o Nelfinavir o Ritonavir o Clarithromycin o Itraconazole o Ketoconazole o Nefazodone o Saquinavir o Telithromycin Moderate Inhibitors of CYP3A4 o Aprepitant o Erythromycin o Fluconazole o Grapefruit juice o Verapamil o Diltiazem
Has patient received any of these strong or moderate inhibitors of CYP3A4
Receiving any medications or substances that are inducers of CYP450 3A4. - Use of the following inducers is prohibited <=12 days prior to registration: o Efavirenz o Nevirapine o Carbamapezine o Modafinil o Phenobarbital o Phenytoin o Pioglitazone o Rifabutin o Rifampin o St. John's wort
Has patient received any of these inducers of CYP3A4 (This question may be answered yes or no.)
Pre-registration Check
A mandatory correlative research component is part of this study for all patients, the patient will be automatically registered onto this component (see Sections 3.18e, 3.18f and 14.11 and 17.4)
Consent form signed and dated
Authorization for use and disclosure of protected health information signed and dated (U.S.A, institutions only If not a USA institution check NA)
Treatment cannot begin prior to registration and must begin <=14 days after registration
Pretreatment tests/procedures must be completed <= 14 days prior to registration (see Section 4.0)
All required baseline symptoms (see Section 10.3) must be documented and graded
Treatment on this protocol must commence at an NCCTG institution under the supervision of an NCCTG member physician
Study drug is available on site
Blood draw kit is available on site
Patient has given permission to store and use his/her sample(s) for use in future research to learn about, prevent, or treat cancer (At the time of registration, the following will be recorded:)
Patient has given permission to store and use his/her sample(s) for use in future research to learn about, prevent, or treat other health problems (for example: diabetes, Alzheimer's disease, or heart disease) (At the time of registration, the following will be recorded:)
Patient has given permission for NCCTG to give his/her sample(s) to outside researchers (At the time of registration, the following will be recorded:)
Patient has agreed to be enrolled on N0392 (NOTE: N0392 must be open at site and offered to patients. At the time of registration, willingness to participate will be recorded. This study is the "Was It Worth It" study and must be included in all NCCTG studies. The study must be open and available at each member site participating in the N1087 study. However, a patient can refuse to go on this study and they are still eligible for participating in N1087.)
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