A Study of the Efficacy of ABT-199 in Subjects With Relapsed/Refractory or Previously Untreated Chronic Lymphocytic Leukemia With the 17p Deletion

Not Recruiting

Trial ID: NCT01889186

Purpose

This was an open-label, multicenter, global study to determine the efficacy of ABT-199 (Venetoclax) monotherapy in participants with relapsed/refractory (R/R) or previously untreated chronic lymphocytic leukemia (CLL) harboring 17p deletion.

Official Title

A Phase 2 Open-Label Study of the Efficacy of ABT-199 (GDC-0199) in Subjects With Relapsed/Refractory or Previously Untreated Chronic Lymphocytic Leukemia Harboring the 17p Deletion

Eligibility


Inclusion Criteria:

   - Participant must be greater than or equal to 18 years of age.

   - Participant must have diagnosis of chronic lymphocytic leukemia (CLL) that meets
   published 2008 Modified IWCLL NCI-WG (International Workshop for Chronic Lymphocytic
   Leukemia National Cancer Institute-Working Group) Guidelines.

      - Participant has an indication for treatment according to the 2008 Modified IWCLL
      NCI WG Guidelines;

      - Participant has clinically measurable disease (lymphocytosis > 5 × 10^9/L and/or
      palpable and measurable nodes by physical exam and/or organomegaly assessed by
      physical exam);

      - Participant must be refractory or have relapsed after receiving at least one
      prior line of therapy (participants that have progressed after 1 cycle of
      treatment or have completed at least 2 cycles of treatment for a given line of
      therapy) or previously untreated CLL (previously untreated CLL participants must
      have received no prior chemotherapy or immunotherapy. Participants with a history
      of emergency, loco-regional radiotherapy (e.g., for relief of compressive signs
      or symptoms) are eligible. In addition, participants must meet the CLL diagnostic
      criteria above and must have > 5 × 10^9/L B-Lymphocytes in the peripheral
      blood.);

      - Participants must have 17p deletion, assessed by local laboratory (in bone marrow
      or peripheral blood) or assessed by central laboratory (peripheral blood).

   - Participant has an Eastern Cooperative Oncology Group (ECOG) performance score of less
   than or equal to 2.

   - Participant must have adequate bone marrow function at Screening as follows:

      - Absolute Neutrophil Count (ANC) greater than or equal to 1000/µL, or

      - For subjects with an ANC less than 1000/µL at Screening and bone marrow heavily
      infiltrated with underlying disease (unless cytopenia is clearly due to marrow
      involvement of CLL), growth factor support may be administered after Screening
      and prior to the first dose of ABT-199 to achieve the ANC eligibility criteria
      (greater than or equal to 1000/µL);

      - Platelets greater than 30,000/mm^3 (without transfusion support within 14 days of
      Screening, without evidence of mucosal bleeding, without known history of
      bleeding episode within 3 months of Screening, and without history of bleeding
      disorder);

      - Hemoglobin greater than or equal to 8.0 g/dL.

   - Participant must have adequate coagulation, renal, and hepatic function, per
   laboratory reference range at Screening as follows:

      - Activated partial thromboplastin time (aPTT) and prothrombin time (PT) not to
      exceed 1.5 × the upper limit of normal;

      - Calculated creatinine clearance greater than 50 mL/min using 24-hour Creatinine
      Clearance or modified Cockcroft-Gault equation (using Ideal Body Mass [IBM]
      instead of Mass). For participants that have body mass index (BMI) of > 30 kg/m^2
      or < 19 kg/m^2, 24-hour measured urine creatinine clearance is required;

      - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or
      equal to 3.0 × the upper normal limit of institution's normal range; Bilirubin
      less than or equal to 1.5 × upper limit of normal. Participants with Gilbert's
      Syndrome may have a bilirubin greater 1.5 × upper limit of normal, per
      correspondence between the investigator and AbbVie medical monitor.

   - For participants at high risk of tumor lysis syndrome a pre-approval by the AbbVie
   medical monitor is required prior to enrollment.

Exclusion Criteria:

   - Participant has undergone an allogeneic stem cell transplant.

   - Participant has developed Richter's transformation confirmed by biopsy.

   - Participant has prolymphocytic leukemia.

   - Participant has active and uncontrolled autoimmune cytopenias (for 2 weeks prior to
   Screening), including autoimmune hemolytic anemia and idiopathic thrombocytopenic
   purpura despite low dose corticosteroids.

   - Participant has previously received ABT-199.

   - Participant has received a biologic agent for anti-neoplastic intent within 30 days
   prior to the first dose of study drug.

   - Participant has received any of the following within 14 days or 5 half-lives as
   applicable prior to the first dose of study drug, or has not recovered to less than
   Common Toxicity Criteria (CTC) grade 2 clinically significant adverse
   effect(s)/toxicity(s) of the previous therapy:

      - Any anti-cancer therapy including chemotherapy, or radiotherapy;

      - Investigational therapy, including targeted small molecule agents.

   - Participant has known allergy to both xanthine oxidase inhibitors and rasburicase.

Intervention(s):

drug: ABT-199 (Main Cohort)

drug: ABT-199 (Safety Expansion Cohort)

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061

New Trial Alerts