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Phase 2
18 Years
Open (Enrolling)
Chronic Lymphocytic Leukemia (CLL)

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Trial Information

Inclusion Criteria:

- Patients must fulfill all of the following criteria to be eligible for admission to
the study:

- A confirmed diagnosis of B-cell CLL by IWCLL 2008 criteria (Appendix 1)

- Patients must have evidence of disease progression as evidenced by rapid
doubling of peripheral lymphocyte count, progressive lymphadenopathy or
hepatosplenomegaly, worsening anemia or thrombocytopenia, or progressive
constitutional symptoms [including fatigue, weight loss, night sweats, fever
(without infection)]

- Must be relapsed or refractory to at least one prior fludarabine-containing
regimen (no maximum number of prior regimens).

- Age > 18 years.

- ECOG performance status of 0, 1 or 2 (Appendix 3)

- Signed the Informed Consent form

- Life expectancy of ≥ 6 months

- Able to swallow and retain oral medication

- Normal HbA1C ≤ 0.07

- Fasting blood sugar < 7mmol/L

Exclusion Criteria:

- Subjects meeting any of the following criteria are excluded from this study:

- CLL therapy, including stem cell transplantation, within 4 weeks of study
initiation. Corticosteroids alone may be administered up to seven days prior to
the first dose of study drug.

- Treatment with any known non-marketed drug substance or experimental therapy
within 5 terminal half lives or 4 weeks prior to enrollment, whichever is
longer, or currently participating in any other interventional clinical study

- Prior treatment with anti-CD20 monoclonal antibody or alemtuzumab within 3
months prior to start of therapy

- Known hypersensitivity to ofatumumab, GSK2110183, or any components therein.

- Anticoagulants are permitted only if the subject meets PTT and INR entry
criteria (INR and PTT ≤ 1.5 times upper normal limit). Their use must be
monitored in accordance with local institutional practice.

- Current use of any anti-platelet agent (e.g. dipyridamole, clopidogrel) other
than aspirin (81mg daily).

- Current use of a prohibited medication based on potential drug-drug interaction
- a complete list is found in Appendix 1

- Known CNS involvement with CLL

- Transformation to aggressive B-cell malignancy (e.g. large B-cell lymphoma,
Richter's syndrome, prolymphocytic leukemia [PLL])

- "Active" autoimmune disease - prior history of autoimmune hemolysis (DAT
positive or negative) or immune thrombocytopenia without current active
autoimmune disease is allowed

- Subjects who have current active hepatic or biliary disease (with exception of
patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or
stable non-hepatitis B or C chronic liver disease per investigator assessment -
please see below for Hepatitis B and C criteria)

- Previously diagnosed diabetes mellitus (Type 1 or 2)

- Other past or current malignancy. Subjects who have been free of malignancy for
at least 5 years, or have a history of completely resected non-melanoma skin
cancer, or successfully treated in situ carcinoma are eligible.

- Chronic or current infectious disease requiring systemic antibiotics,
antifungal, or antiviral treatment such as, but not limited to, chronic renal
infection, chronic chest infection with bronchiectasis, and tuberculosis.

- Any medical condition that would require long-term use (> 1 month) of systemic
corticosteroids during study treatment (excludes topical or inhaled
corticosteroid use)

- History of significant cerebrovascular disease in the past 6 months or ongoing
event with active symptoms or sequelae

- QTc ≥ 470 msec on screening ECG

- Clinically significant cardiac disease including unstable angina, acute
myocardial infarction within six months prior to study entry, congestive heart
failure (NYHA III-IV), and arrhythmia unless controlled by therapy, with the
exception of extra systoles or minor conduction abnormalities.

- Significant concurrent, uncontrolled medical condition including, but not
limited to, renal, hepatic, gastrointestinal, endocrine, pulmonary,
neurological, cerebral or psychiatric disease which in the opinion of the
investigator may represent a risk for the patient.

- Any major surgery within the prior 4 weeks.

- Known HIV positive

- 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.

- Positive serology for hepatitis C (HC) defined as a positive test for HCAb, in
which case reflexively perform a HC RIBA immunoblot assay on the same sample to
confirm the result

- Screening laboratory values: platelets ≤ 30 x 109/L,neutrophils ≤ 0.7 x
109/L,creatinine ≥ 2.0 times upper normal limit, total bilirubin ≥ 1.5 times
upper normal limit (unless due to a known history of Gilbert's disease), ALT ≥
2.5 times upper normal limit, alkaline phosphatase ≥ 2.5 times upper normal
limit, INR and PTT ≤ 1.5 times upper normal limit

- Pregnant or lactating women. Women of childbearing potential must have a
negative pregnancy test at screening.

- Women of childbearing potential, including women whose last menstrual period was
less than one year prior to screening, unable or unwilling to use adequate
contraception from study start to one year after the last dose of protocol
therapy. Adequate contraception is defined as intrauterine device, double
barrier method or total abstinence. Oral contraceptives are not adequate due to
potential drug-drug interaction.

- Male subjects unable or unwilling to use adequate contraception methods from
study start to one year after the last dose of protocol therapy.

Type of Study:


Study Design:

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

Outcome Measure:

overall response rate, including complete and partial responses as per the IWCLL 2008 response criteria

Outcome Description:

Assessment of efficacy (overall response rate, including complete and partial responses as per the IWCLL 2008 response criteria) of ofatumumab in combination with GSK2110183 in the treatment of patients with relapsed or refractory CLL who have received at least one prior fludarabine-containing regimen.

Outcome Time Frame:

36 months

Safety Issue:


Principal Investigator

Christine Chen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Health Network, Toronto


Canada: Health Canada

Study ID:




Start Date:

February 2012

Completion Date:

February 2015

Related Keywords:

  • Chronic Lymphocytic Leukemia (CLL)
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid