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A Phase 1b Study Evaluating the Safety and Tolerability of ABT-199 in Combination With Rituximab in Subjects With Relapsed Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma

Phase 1
18 Years
Open (Enrolling)
Small Lymphocytic Lymphoma, Chronic Lymphocytic Leukemia

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Trial Information

A Phase 1b Study Evaluating the Safety and Tolerability of ABT-199 in Combination With Rituximab in Subjects With Relapsed Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma

Inclusion Criteria:

- Subject must be greater then or equal to 18 years of age.

- Subject must have relapsed Chronic Lymphocytic Leukemia or Small Lymphocytic

- Subject has an Eastern Cooperative Oncology Group performance score of less than or
equal to 1.

- Subject must have adequate bone marrow independent of growth factor support per local
laboratory reference range at Screening.

- Subject must have adequate coagulation, renal, and hepatic function, per laboratory
reference range at Screening.

Exclusion Criteria:

- Chronic lymphocytic leukemia or Small Lymphocytic Lymphoma subject has undergone an
allogeneic or autologous stem cell transplant.

- Subject has uncontrolled autoimmune hemolytic anemia or thrombocytopenia.

- Subject has tested positive for human immunodeficiency virus.

- Seropositivity for hepatitis B surface antigen or hepatitis C virus antibody or
ribonucleic acid.

- History of severe allergic or anaphylactic reactions to rituximab.

- Subject has received a live viral vaccine within 6 months prior to the first dose of
study drug.

- Subject has received a monoclonal antibody for anti-neoplastic intent within 8 weeks
prior to the first dose of study drug.

- 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 grade 2 clinically significant adverse
effect(s)/toxicity(s) of the previous therapy:

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

- Investigational therapy, including targeted small molecule agents.

- Subject has a cardiovascular disability status of New York Heart Association Class
greater then or equal to 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.

- Subject has a significant history of renal, neurologic, psychiatric, pulmonary,
endocrinologic, metabolic, immunologic, cardiovascular, or hepatic disease that in
the opinion of the investigator would adversely affect his/her participating in this

- Subject has a history of other active malignancies other than CLL/SLL within the past
2 years prior to study entry, with the exception of:

- Adequately treated in situ carcinoma of the cervix uteri;

- Basal cell carcinoma of the skin or localized squamous cell carcinoma of the

- Previous malignancy confined and surgically resected (or treated with other
modalities) with curative intent.

- Subject has malabsorption syndrome or other condition that precludes enteral route of

- Subject has a history of a prior significant toxicity, other than thrombocytopenia or
neutropenia from another Bcl-2 family protein inhibitor.

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Assess the safety profile, to determine the maximum tolerated dose and Recommended Phase Two Dose of ABT-199 when administered in combination with rituximab (R) in subjects with relapsed chronic lymphocytic leukemia and small lymphocytic lymphoma.

Outcome Description:

Protocol-defined events, which are attributed as having a reasonable possibility of being related to the administration of ABT-199 and/or rituximab, or can not be attributed by the investigator to a clearly identifiable cause such as tumor progression, concurrent illness, underlying disease or concomitant medication, will be considered a dose limiting toxicity.

Outcome Time Frame:

Continuous dosing with study drug at the designated cohort dose level up to Month 6. At the end of combination treatment, ABT-199 monotherapy may continue for up to 2 years following the date of the last subject enrolled.

Safety Issue:


Principal Investigator

Elisa Cerri, MD

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

August 2012

Completion Date:

February 2016

Related Keywords:

  • Small Lymphocytic Lymphoma
  • Chronic Lymphocytic Leukemia
  • Tolerability
  • Chronic Lymphocytic Leukemia
  • Efficacy
  • Rituximab
  • Safety
  • Maximum Tolerated Dose
  • Preliminary
  • ABT-199
  • Cancer
  • Pharmacokinetics
  • Small Lymphocytic Lymphoma
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Lymphoma



Site Reference ID/Investigator# 70398 La Jolla, California  92093-0698
Site Reference ID/Investigator# 71593 Chicago, Illinois  60611
Site Reference ID/Investigator# 71813 New Hyde Park, New York  11042
Site Reference ID/Investigator# 71393 Durham, North Carolina  27710