Cancer drug aims to mop up remaining leukemia cells after chemo
NCT ID NCT01258933
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested the drug ofatumumab (Arzerra) in people with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who still had signs of disease after chemotherapy. The goal was to see if the drug could clear remaining cancer cells and keep the disease under control. Only 4 people took part, and the trial was stopped early, so the findings are very limited.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Ofatumumab (Arzerra)
- What this could lead to
- If successful, this could show that ofatumumab helps clear remaining cancer cells after chemotherapy, potentially delaying relapse in CLL or SLL patients.
- What could go wrong
- This was a very small, early-phase trial that was terminated early, so results are limited. The drug may not work for everyone and can cause side effects like infusion reactions or infections.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
4 people
The number who actually took part.
- Started
-
Jul 2011
- Finished
-
Oct 2024
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 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. Exclusion Criteria: 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
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Other studies related to the condition(s) this trial covers.
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