LeukemiaPhase 2NCT01258933
Ofatumumab for Minimal Residual Disease (MRD) and Maintenance Therapy
A Phase 2 study testing Ofatumumab in people with Leukemia and Lymphoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Ofatumumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jul 2011to 18 Oct 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: 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.
Read the 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 cancers of B-cells such as B-CLL.
Study Drug Administration If you are found to be eligible to take part in this study, you will receive ofatumumab up to 20 times during this study. You will receive 8 weekly infusions and then an infusion every 2 months for 2 years or until the disease gets worse. You will receive ofatumumab by vein over about 6 ½ hours the first time and over 4 hours for all the following infusions. The first infusion will be the smallest dose. The second and later infusions will be 3 times larger than the first.
Before you receive the study drug each time, you will receive Tylenol (acetaminophen) by mouth to reduce the risk of fever. You will receive Benadryl (diphenhydramine) by mouth or vein and prednisolone (a steroid) by vein over about 30 minutes to reduce the risk of an allergic reaction or an infusion reaction.
During the infusions, you will be monitored closely. You will be expected to stay in clinic for about 71/2 hours on the day of the first infusion and 5 hours for all other infusions.
You will be seen at MD Anderson for mandatory visits for enrollment, ofatumumab infusions, for response assessment after 8 weekly ofatumumab doses (Month 3), during maintenance every 6 months and for follow-up at least once a year. Your local doctor may perform other visits and laboratory studies.
If you decide to have your local doctor perform study visits and laboratory studies, a letter will be sent to your doctor, describing your participation in this study and asking for your doctor's agreement to help manage your care.
Study Visits
The following tests and procedures will be performed every other week during Weeks 1- 8 (Weeks 1, 3, 5 and 7):
You will have a complete physical exam including measurement of your vital signs.
Your medical history will be recorded. Blood (about 2 teaspoons) will be drawn for routine tests.
Starting at Month 3, you will have the following tests and procedures every 2 Months:
You will have a complete physical exam including measurement of your vital signs.
Your medical history will be recorded. Blood (about 2 teaspoons) will be drawn for routine tests.
Starting at Month 3, you will also have the following tests and procedures every 6 months, in addition to the ones performed every 2 months:
Blood (about an additional 1 teaspoon) will be drawn for other routine tests. You may have CT scans to check the status of the disease, if your doctor thinks that this test is needed (at Month 3 only).
You will have a bone marrow aspirate/biopsy to check the status of the disease.
Additional Information Depending on the results of your hepatitis tests performed at the screening visit, you may have additional hepatitis tests. The study staff will tell you if you will have these tests performed. If you do have the additional hepatitis tests, blood (about 2 teaspoons) will be drawn during Months 3-24. The blood will be drawn at the same time of the routine blood draws to prevent unnecessary needle sticks.
Length of Study You may continue taking the study drug for up to 20 doses (up to 24 months). You will no longer be able to take the study drug if the disease gets worse or intolerable side effects occur.
Your participation on the study will be over once you have completed the follow-up visits, which will last until you begin receiving any other treatment.
Follow Up Visits Every 3 Months You will have a complete physical exam including measurement of your vital signs.
Your medical history will be recorded. Blood (about 2 teaspoons every 3 months, about 1 teaspoon every 6 months) will be drawn for routine tests.
If your doctor thinks it is needed, blood (about 2 teaspoons) will be drawn for hepatitis testing.
Every 6 Months, you will have a bone marrow aspirate/biopsy to check the status of the disease.
This is an investigational study. Ofatumumab is FDA approved for CLL resistant to standard chemotherapy. Ofatumumab's use in patients with residual CLL or SLL is investigational.
Ofatumumab will be provided at no cost to you while you are on the study.
Up to 42 patients will take part in this study. All will be enrolled at MD Anderson.
- Being tested
- Ofatumumab
- Keywords
- Leukemia, Chronic Lymphocytic Leukemia, CLL, Lymphoma, Small Lymphocytic Lymphoma, SLL, Ofatumumab
- Medical subject headings
- Leukemia, Lymphoma, Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OfatumumabDrug
Also called Arzerra
300 mg Dose 1, then 1,000 mg weekly x 7, (treatment) then 1,000 mg every 2 months beginning on week 12
| Study group | Role | What they receive |
|---|---|---|
| Ofatumumab | Experimental | Ofatumumab 300 mg dose 1, then 1,000 mg weekly * 7, (treatment) then 1,000 mg every 2 months beginning on week 12 for a total of 2 years of treatment or until progression (maintenance) of disease. The follow-up period will be the period after completion of maintenance. Receives: Drug: Ofatumumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Objective Response
Response assessment according to 2008 International Working Group for CLL (IWCLL), prior to 9th dose of ofatumumab (prior to first bimonthly dose). Responses of (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)) evaluated by physical examination, CBC, CT of chest, abdomen, pelvis, and bone marrow aspirate and biopsy with evaluation of residual disease (MRD) by 4-color flow cytometry.
Measured: Week 12
Secondary outcomes (2)
Time-to-Treatment Failure (TTF)
Time from date of treatment start until the date of failure or death from any cause.
Measured: Start of study drug up to approximately 1 year and 7 months.
Progression-Free Survival (PFS)
Time from date of treatment start until the date of progression or death from leukemia.
Measured: Start of study drug up to approximately 7 years and 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2010 (estimated)
- Study start6 Jul 2011
- Primary completion18 Oct 2024
- Study completion18 Oct 2024
Why it stopped: Slow Accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- William G Wierda, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01258933
- Sponsor's protocol ID
- 2010-0266
- Other IDs
- NCI-2011-00274
- Status last verified
- Sep 2025
- First submitted
- 9 Dec 2010
- Last updated
- 1 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ofatumumab for Residual Disease and Maintenance Following Chemotherapy or Chemoimmunotherapy in Patients With Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)
- ClinicalTrials.gov ID
- NCT01258933
- Acronym / sponsor ID
- 2010-0266
- Keywords
- Leukemia, Chronic Lymphocytic Leukemia, CLL, Lymphoma, Small Lymphocytic Lymphoma, SLL, Ofatumumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow Accrual
- Enrolment
- 4 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- 6 Jul 2011 (actual)
- Primary completion
- 18 Oct 2024 (actual)
- Study completion
- 18 Oct 2024 (actual)
- First posted
- 13 Dec 2010 (estimated)
- Results
- Posted 1 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 cancers of B-cells such as B-CLL.
Study Drug Administration If you are found to be eligible to take part in this study, you will receive ofatumumab up to 20 times during this study. You will receive 8 weekly infusions and then an infusion every 2 months for 2 years or until the disease gets worse. You will receive ofatumumab by vein over about 6 ½ hours the first time and over 4 hours for all the following infusions. The first infusion will be the smallest dose. The second and later infusions will be 3 times larger than the first.
Before you receive the study drug each time, you will receive Tylenol (acetaminophen) by mouth to reduce the risk of fever. You will receive Benadryl (diphenhydramine) by mouth or vein and prednisolone (a steroid) by vein over about 30 minutes to reduce the risk of an allergic reaction or an infusion reaction.
During the infusions, you will be monitored closely. You will be expected to stay in clinic for about 71/2 hours on the day of the first infusion and 5 hours for all other infusions.
You will be seen at MD Anderson for mandatory visits for enrollment, ofatumumab infusions, for response assessment after 8 weekly ofatumumab doses (Month 3), during maintenance every 6 months and for follow-up at least once a year. Your local doctor may perform other visits and laboratory studies.
If you decide to have your local doctor perform study visits and laboratory studies, a letter will be sent to your doctor, describing your participation in this study and asking for your doctor's agreement to help manage your care.
Study Visits
The following tests and procedures will be performed every other week during Weeks 1- 8 (Weeks 1, 3, 5 and 7):
You will have a complete physical exam including measurement of your vital signs.
Your medical history will be recorded. Blood (about 2 teaspoons) will be drawn for routine tests.
Starting at Month 3, you will have the following tests and procedures every 2 Months:
You will have a complete physical exam including measurement of your vital signs.
Your medical history will be recorded. Blood (about 2 teaspoons) will be drawn for routine tests.
Starting at Month 3, you will also have the following tests and procedures every 6 months, in addition to the ones performed every 2 months:
Blood (about an additional 1 teaspoon) will be drawn for other routine tests. You may have CT scans to check the status of the disease, if your doctor thinks that this test is needed (at Month 3 only).
You will have a bone marrow aspirate/biopsy to check the status of the disease.
Additional Information Depending on the results of your hepatitis tests performed at the screening visit, you may have additional hepatitis tests. The study staff will tell you if you will have these tests performed. If you do have the additional hepatitis tests, blood (about 2 teaspoons) will be drawn during Months 3-24. The blood will be drawn at the same time of the routine blood draws to prevent unnecessary needle sticks.
Length of Study You may continue taking the study drug for up to 20 doses (up to 24 months). You will no longer be able to take the study drug if the disease gets worse or intolerable side effects occur.
Your participation on the study will be over once you have completed the follow-up visits, which will last until you begin receiving any other treatment.
Follow Up Visits Every 3 Months You will have a complete physical exam including measurement of your vital signs.
Your medical history will be recorded. Blood (about 2 teaspoons every 3 months, about 1 teaspoon every 6 months) will be drawn for routine tests.
If your doctor thinks it is needed, blood (about 2 teaspoons) will be drawn for hepatitis testing.
Every 6 Months, you will have a bone marrow aspirate/biopsy to check the status of the disease.
This is an investigational study. Ofatumumab is FDA approved for CLL resistant to standard chemotherapy. Ofatumumab's use in patients with residual CLL or SLL is investigational.
Ofatumumab will be provided at no cost to you while you are on the study.
Up to 42 patients will take part in this study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ofatumumab | Experimental | Drug: OfatumumabOfatumumab 300 mg dose 1, then 1,000 mg weekly * 7, (treatment) then 1,000 mg every 2 months beginning on week 12 for a total of 2 years of treatment or until progression (maintenance) of disease. The follow-up period will be the period after completion of maintenance. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OfatumumabAlso: Arzerra300 mg Dose 1, then 1,000 mg weekly x 7, (treatment) then 1,000 mg every 2 months beginning on week 12 | Drug | Ofatumumab |
Primary outcome
Number of Patients With Objective Response
Time frame: Week 12
Response assessment according to 2008 International Working Group for CLL (IWCLL), prior to 9th dose of ofatumumab (prior to first bimonthly dose). Responses of (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)) evaluated by physical examination, CBC, CT of chest, abdomen, pelvis, and bone marrow aspirate and biopsy with evaluation of residual disease (MRD) by 4-color flow cytometry.
2 secondary outcomes
Time-to-Treatment Failure (TTF)
Time frame: Start of study drug up to approximately 1 year and 7 months.
Progression-Free Survival (PFS)
Time frame: Start of study drug up to approximately 7 years and 6 months.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William G Wierda, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ofatumumab in people with Leukemia and Lymphoma, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients With Objective Response (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025.