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ABBV 1913   |   13-1173
A Phase 2 Open-Label Study of the Efficacy of ABT-199 (GDC-0199) in Subjects with Relapsed or Refractory Chronic Lymphocytic Leukemia Harboring the 17p Deletion

Leukemia, Chronic Lymphocytic (CLL)
Main Campus
Phase 2

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  1. The primary objective of this study is to evaluate the efficacy of ABT-199 monotherapy in subjects with relapsed or refractory chronic lymphocytic leukemia (CLL) harboring the 17p deletion. Efficacy will be measured by overall response rate (ORR).
  2. The secondary objectives are to evaluate the duration of overall response, complete remission rate (CR rate), partial remission rate (PR rate), progression-free survival (PFS), time to progression (TTP), overall survival (OS) and percent of subjects who move on to stem cell transplant. The safety and tolerability of ABT-199 in subjects with relapsed or refractory CLL harboring 17p deletion will also be evaluated.

Inclusion Criteria
  1. Subject must voluntarily sign and date an informed consent, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study specific procedures.
  2. Subject must be ≥ 18 years of age.
  3. Subject must have diagnosis of CLL that meets published 2008 IWCLL NCI-WG criteria.
    1. Subject has an indication for treatment according to the 2008 IWCLL NCI-WG criteria;
    2. Subject has clinically measurable disease;
    3. Subject must have relapsed or be refractory after receiving at least one prior line of therapy (a line of therapy is defined as completing at least 2 cycles of treatment for a given line of therapy);
    4. Subjects must have 17p deletion, assessed by central laboratory, and determined by FISH using the Vysis CLL probe kit.
  4. Subject has an Eastern Cooperative Oncology Group (ECOG) performance score of ≤ 2.
  5. Subject must have adequate bone marrow function at Screening as follows:
    1. Absolute Neutrophil Count (ANC) ≥ 1000/mL, or
    2. For subjects with an ANC < 1000/mL at Screening and bone marrow heavily infiltrated with underlying disease (approximately 80% or more), G-CSF may be administered after Screening and prior to the first dose of ABT-199 to achieve the ANC eligibility criteria (≥ 1000/mL);
    3. Platelets > 40,000/mm^3 (entry platelet count must be independent of transfusion within 14 days of Screening);
    4. Hemoglobin ≥ 8.0 g/dL.
  6. Subject must have adequate coagulation, renal, and hepatic function, per laboratory reference range at Screening as follows:
    1. aPTT and PT not to exceed 1.5 � the upper limit of normal (ULN);
    2. Calculated creatinine clearance > 50 mL/min using 24-hour Creatinine Clearance or modified Cockcroft-Gault equation (using Ideal Body Mass [IBM] instead of Mass):
    3. AST and ALT ≤ 3.0 � the upper normal limit (ULN) of institutions normal range; Bilirubin ≤ 1.5 � ULN. Subjects with Gilberts Syndrome may have a bilirubin > 1.5 � ULN, per discussion between the investigator and AbbVie medical monitor.
  7. Female subjects of childbearing potential and non-sterile male subjects must practice at least one of the following methods of birth control with partner(s) beginning with initial study drug administration and continuing to 90 days after the last dose of study drug:
    1. Total abstinence from sexual intercourse as the preferred life style of the subject; periodic abstinence is not acceptable;
    2. Surgically sterile partner(s); acceptable sterility surgeries are: vasectomy, bilateral tubal ligation, bilateral oophorectomy or hysterectomy;
    3. Intrauterine device (IUD);
    4. Double-barrier method (contraceptive sponge, diaphragm or cervical cap with spermicidal jellies or cream AND a condom);
    5. Hormonal contraceptives (oral, parenteral or transdermal) for at least 3 months prior to study drug administration; If hormonal contraceptives are used, the specific contraceptive must have been used for at least 3 months prior to study drug administration. If the subject is currently using a hormonal contraceptive, she should also use a barrier method during this study from initial study drug administration to 90 days after the last dose of study drug. Any contraception method must be continued for 90 days after the last dose of study drug.
  8. Females of childbearing potential (i.e., not postmenopausal for at least 2 years or surgically sterile) must have negative results for pregnancy test performed:
    1. At Screening with a serum sample obtained within 14 days prior to the first study drug administration, and
    2. Prior to dosing with a urine sample obtained on Week 1 Day 1, if it has been > 7 days since obtaining the serum pregnancy test results.
  9. Male subjects must agree to refrain from sperm donation, from initial study drug administration until 90 days after the last dose of study drug.
  10. For high risk subjects (as defined in Section 6.7.1) a pre-approval by the AbbVie medical monitor is required prior to enrollment.

Exclusion Criteria
  1. Subject has undergone an allogeneic stem cell transplant.
  2. Subject has developed Richters transformation.
  3. Subject has active and uncontrolled autoimmune cytopenias (for 2 weeks), including autoimmune hemolytic anemia (AIHA) and idiopathic thrombocytopenic purpura (ITP).
  4. Subject has previously received ABT-199.
  5. Subject has tested positive for HIV (due to potential drug-drug interactions between anti-retroviral medications and ABT-199, as well as anticipated ABT-199 mechanism based lymphopenia that may potentially increase the risk of opportunistic infections).
  6. Subject has received the following within 8 weeks prior to the first dose of study drug:
    1. A biologic agent (i.e., monoclonal antibodies) for anti-neoplastic intent.
  7. Subject has received any of the following within 14 days prior to the first dose of study drug, or has not recovered to less than CTC grade 2 clinically significant adverse effect(s)/toxicity(s) of the previous therapy:
    1. Any anti-cancer therapy including chemotherapy, or radiotherapy;
    2. Investigational therapy, including targeted small molecule agents.
  8. Subject has received the following within 7 days prior to the first dose of study drug:
    1. Steroid therapy for anti-neoplastic intent;
    2. CYP3A inhibitors (such as fluconazole, ketoconazole, and clarithromycin);
    3. Potent CYP3A inducers (e.g., rifampin, phenytoin, carbamazepine or St. Johns Wort);
    4. Warfarin or requires the use of warfarin (due to potential drug-drug interactions that may potentially increase the exposure of warfarin and complications of this effect);
    5. Antiretroviral medications.
  9. Subject has consumed the following within 3 days prior to the first dose of study drug.
    1. Grapefruit or grapefruit products;
    2. Seville oranges (including marmalade containing Seville oranges);
    3. Star fruit.
  10. Subject has known allergy to both xanthine oxidase inhibitors and rasburicase.
  11. Subject has a cardiovascular disability status of New York Heart Association Class ≥ 2. Class 2 is defined as cardiac disease in which subjects are comfortable at rest but ordinary physical activity, results in fatigue, palpitations, dyspnea or anginal pain.
  12. Subject exhibits evidence of other clinically significant uncontrolled condition(s) including, but not limited to:
    1. Uncontrolled systemic infection (viral, bacterial, or fungal).
  13. Subject has a significant history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, cardiovascular, or hepatic disease that in the opinion of the investigator would adversely affect his/her participating in this study. For subjects who have required an intervention for any above diseases within the past 6 months a discussion with the investigator and the AbbVie medical monitor must occur.
  14. A female subject is pregnant or breast-feeding.
  15. Subject has a history of active malignancies other than CLL within the past 2 years prior to study entry, with the exception of:
    1. Adequately treated in situ carcinoma of the cervix uteri;
    2. Adequately treated basal cell carcinoma or localized squamous cell carcinoma of the skin;
    3. Previous malignancy confined and surgically resected (or treated with other modalities) with curative intent.
  16. Subject has malabsorption syndrome or other condition that precludes enteral route of administration.

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