Ofatumumab for Residual Disease and Maintenance Following Chemotherapy or Chemoimmunotherapy in Patients with Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)
The goal of this clinical research study is to find out if ofatumumab can control CLL or SLL that is left after chemotherapy or chemoimmunotherapy. The safety of the drug will also be studied.
Disease Group: Leukemia
Treatment Agent: Ofatumumab
Treatment Location: Only at MD Anderson
Primary: Response rate (complete remission (CR) conversion to minimal residual disease (MRD) negative, partial remission (PR) conversion to nodular partial remission nPR or CR, and nPR conversion to complete remission (CR) with ofatumumab treatment in patients with residual disease. Secondary: Determine the time-to-treatment failure and progression-free survival. Determine the time-to-next chronic lymphocytic leukemia (CLL) treatment after ofatumumab Evaluate the safety and tolerability of ofatumumab for residual disease. Evaluate the pharmacokinetics of ofatumumab in this trial for residual disease and in maintenance.
IRB Review and Approval Date: 07/06/2011
Recruitment Status: Closed
Projected Accrual: N/A
1) Diagnosis of CD20+ chronic lymphocytic leukemia (CLL) or small
lymphocytic lymphoma (SLL) treated with chemotherapy or
chemoimmunotherapy: Post-frontline therapy, patients must have
non-progressing disease and be 4 months to 1 year post treatment.
Post-treatment for relapsed CLL, eligible patients must have
non-progressing disease and be 3 months to 1 year post treatment.
2) Patients (CR, nPR, or PR at enrollment) must have measurable disease, which may include MRD by 4-color flow cytometry.
3) Adequate renal and hepatic function (creatinine < 2 mg/dL, bilirubin < 2 mg/dL). Patients with renal or liver dysfunction due to organ infiltration by lymphocytes may be eligible after discussion with the study chairman. Patients with Gilbert's syndrome are eligible.
4) Age >/= 18 years.
5) ECOG performance status of 0-2.
6) Provide informed consent indicating patient is aware of the investigational nature of this study according to the policies of the MDACC IRB.
7) Patients of childbearing potential (females who have not been postmenopausal for at least 12 consecutive months or who have not undergone previous surgical sterilization or males who have not been surgically sterilized) must be willing to practice birth control during the study.
1) Positive serology for Hepatitis B virus (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.
2) Concurrent chemotherapy, radiotherapy, or immunotherapy, including other monoclonal antibodies. Localized radiotherapy to an area not comprising bone marrow function does not apply.
3) Active infection or significant medical illness, including current active hepatic or biliary disease (with exception of patients with asymptomatic gallstones, liver involved with CLL or stable chronic liver disease per investigator assessment).
4) Pregnant and breastfeeding females are excluded.