Status:
TERMINATED
Ofatumumab for Minimal Residual Disease (MRD) and Maintenance Therapy
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Leukemia
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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.
Detailed Description
The Study Drug: Ofatumumab is designed to bind to the surface of some white blood cells (B-cells) and to kill these cells. It can destroy cancer cells that come from B-cells, and can be used to treat...
Eligibility Criteria
Inclusion
- 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.
- Patients (CR, nPR, or PR at enrollment) must have measurable disease, which may include MRD by 4-color flow cytometry.
- 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.
- Age \>/= 18 years.
- ECOG performance status of 0-2.
- Provide informed consent indicating patient is aware of the investigational nature of this study according to the policies of the MDACC IRB.
- 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.
Exclusion
- 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.
- Concurrent chemotherapy, radiotherapy, or immunotherapy, including other monoclonal antibodies. Localized radiotherapy to an area not comprising bone marrow function does not apply.
- 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).
- Pregnant and breastfeeding females are excluded.
Key Trial Info
Start Date :
July 6 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 18 2024
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT01258933
Start Date
July 6 2011
End Date
October 18 2024
Last Update
October 1 2025
Active Locations (1)
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1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030