Chronic Lymphocytic LeukemiaPhase 2NCT01243190
Ofatumumab for High-Risk Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
A Phase 2 study testing Ofatumumab in people with Chronic Lymphocytic Leukemia, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to learn if ofatumumab can help to control CLL/SLL that has not yet been treated. The safety of this drug will also be studied. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia
- What is being tested?
- Ofatumumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to 28 Mar 2023
- 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 chronic lymphocytic leukemia (CLL)/ small lymphocytic leukemia (SLL), previously untreated, Rai stage 0-ll
- At least 1 of the following high-risk features for previously untreated patients: Rai stage II disease; Rai stage 0-I with disease-related fatigue; Serum beta2M >/= 3 mg/L; Absolute lymphocyte count >/= 25,000/uL; Unmutated IGHV gene or IGHV3-21; ZAP70 positive (>/= 20% by flow cytometry or positive by immunohistochemistry); CD38 positive (>/= 30% by flow cytometry); OR Deletion 11q or 17p by FISH
- ECOG PS </= 2
- Age >/= 18 years
- Patients must have adequate renal and hepatic function (creatinine <2mg/dL, total bilirubin <2mg/dL). Patients with renal or liver dysfunction due to organ infiltration with CLL may be eligible after discussion with the study chairman
- Provide informed consent
- Female patients (including those < 1 year post-menopausal) and male patients who have not undergone previous surgical sterilization must agree to use contraception.
Who cannot join
- Presence of 2008 IWCLL/NCI-WG indication for CLL treatment: Constitutional symptoms related to CLL/SLL: Fever > 100.5 degrees F for >/= 2 weeks or night sweats for > 1 mo, both without evidence of infection; Unintentional weight loss of >/= 10% body weight in previous 6 months; Extreme fatigue (ECOG PS > 2; inability to work or perform usual activities); Lymphocyte doubling time of </= 6 months or 50% increase in absolute lymphocyte count within 2 months; Progressive anemia (Rai stage III) or thrombocytopenia (Rai stage IV); Recurrent infections unrelated to hypogammaglobulinemia; Autoimmune phenomenon poorly responsive to corticosteroids or other standard therapy; Massive, progressive or symptomatic lymphadenopathy (> 10 cm in longest diameter) or splenomegaly (> 6 cm below left costal margin)
- Prior or concurrent chemotherapy, radiotherapy, or immunotherapy for CLL
- Active infection (febrile and requiring IV/PO antibiotics), including hepatitis C or HIV, or significant medical illness including renal, cardiac, pulmonary disease, or current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment)
- 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 patient will be excluded. -- Consult with a physician experienced in care and management of subjects with hepatitis B to manage/treat subjects who are anti-HB positive.
- Pregnant or breast feeding females are not eligible.
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 Early Treatment for High-Risk Treatment-Naive, Early Stage (0-II) Patients With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
The goal of this clinical research study is to learn if ofatumumab can help to control CLL/SLL that has not yet been treated. The safety of this drug will also be studied.
Read the detailed description
The Study Drug:
Ofatumumab is designed to bind to the surface of some of the white blood cells (B-cells). It may destroy cancer cells that come from B-cells.
Study Drug Administration:
If you are found to be eligible to take part in this study, you will receive a "loading dose" (a lower dose given first, to lower the risk of a bad reaction to the study drug) of ofatumumab by vein on Day 1 of Cycle 1. The loading dose is less than one-third (1/3) of the normal dose. You will then receive the normal dose over 4 hours 1 time each week (+/- 3 days). The doses may be given more slowly, if your doctor thinks it is needed. All doses of the study drug will be given at M. D. Anderson.
Benadryl (diphenhydramine) and glucocorticoids (steroids such as prednisolone) will be given by vein 30 minutes to 2 hours before you receive ofatumumab to help prevent side effects. You will also take pills of acetaminophen (Tylenol) to help prevent side effects. If no side effects occur, these "pre-medications" may be reduced or not given after the second infusion.
Study Visits:
One (1) time each week, before you receive ofatumumab:
- You will have a physical exam, including measurement of your vital signs.
- You will be asked about how you are feeling, about any side effects you may be having, and about any changes in your health since the last visit.
- Blood (about 2 teaspoons) will be drawn for routine tests.
Length of Study:
You may continue taking the study drug until Day 50, as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, if you develop hepatitis B, or if you decide to go off study.
End-of-Treatment Visit:
On the day of your last treatment or after you stop receiving the study drug for any reason, the following tests and procedures will be performed:
- You will have a physical exam, including measurement of your vital signs.
- You will be asked about how you are feeling, about any side effects you may be having, and about any changes in your health since the last visit.
- Blood (about 2 teaspoons) will be drawn for routine tests.
- If the doctor thinks it is needed, blood (about 2 teaspoons) will be drawn for hepatitis testing.
Follow-Up:
About 3 months (+/- 2 weeks) after the end-of-treatment visit, the following tests and procedures will be performed:
- You will have a physical exam, including measurement of your vital signs.
- You will be asked about how you are feeling, about any side effects you may be having, and about any changes in your health since the last visit.
- You will have a bone marrow aspirate and biopsy, as well as CT scans of the chest, abdomen, and pelvis, to check the status of the disease.
- Blood (about 2 teaspoons) will be drawn for routine tests.
- If the doctor thinks it is needed, blood (about 2 teaspoons) will be drawn for hepatitis testing.
Every 3 months (+/- 4 weeks) after the end-of-treatment visit for 6 months:
- You will have a physical exam, including measurement of your vital signs.
- You will be asked about how you are feeling, about any side effects you may be having, and about any changes in your health since the last visit.
- Blood (about 2 teaspoons) will be drawn for routine tests.
- If the doctor thinks it is needed, blood (about 2 teaspoons) will be drawn for hepatitis testing.
Every year (+/- 4 weeks) after the end-of-treatment visit:
- You will have a physical exam, including measurement of your vital signs.
- You will be asked about how you are feeling, about any side effects you may be having, and about any changes in your health since the last visit.
- Blood (about 2 teaspoons) will be drawn for routine tests.
- You will have a bone marrow aspirate and biopsy, as well as CT scans of the chest, abdomen, and pelvis, to check the status of the disease.
This is an investigational study. Ofatumumab is FDA approved and commercially available for use in the treatment of CLL. The use of ofatumumab as an early treatment for patients with CLL/SLL who have not received other treatment is investigational.
Up to 44 patients will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Chronic Lymphocytic Leukemia
- Being tested
- Ofatumumab
- Keywords
- leukemia, small lymphocytic leukemia, SLL, CLL, ofatumumab, untreated, early stage, high-risk
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OfatumumabDrug
Also called Arzerra
Loading first dose 300 mg by vein on Day 1 of Cycle 1; and full dose 1000 mg over 4 hours 1 time each week for 7 additional weekly doses (8 doses).
| Study group | Role | What they receive |
|---|---|---|
| Ofatumumab | Experimental | Loading dose 300 mg by vein on Day 1 of Cycle 1; and full dose 1000 mg over 4 hours 1 time each week for 7 additional weekly doses (8 doses). Receives: Drug: Ofatumumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Complete Response (CR)
2008 International Workshop on CLL (IWCLL) update of the National Cancer Institute-sponsored Working Group (NCI-WG) outlined specific criteria of Complete Response (CR) for diagnosing CLL. CR is defined as Marrow normocellular, no CLL cells, no B-lymphoid nodules, hemoglobin of ≥11.0 g/dL (untransfused and without erythropoietin), Platelet count of ≥100 × 10^9/L, circulating lymphocyte count normal, no constitutional symptoms, Liver and/or spleen size <13 cm; liver size normal, lymph nodes ≥ 1.5 cm.
Measured: Up to 12 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2010 (estimated)
- Study startMar 2011
- Primary completion28 Mar 2023
- Study completion28 Mar 2023
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 Chronic Lymphocytic 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
- 44 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. Weirda, BS,MD,PhD, Study chair, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01243190
- Sponsor's protocol ID
- 2010-0241
- Other IDs
- NCI-2011-00745
- Status last verified
- Aug 2024
- First submitted
- 12 Nov 2010
- Last updated
- 19 Sep 2024
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ofatumumab Early Treatment for High-Risk Treatment-Naive, Early Stage (0-II) Patients With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
- ClinicalTrials.gov ID
- NCT01243190
- Acronym / sponsor ID
- 2010-0241
- Conditions
- Chronic Lymphocytic Leukemia
- Keywords
- leukemia, small lymphocytic leukemia, SLL, CLL, ofatumumab, untreated, early stage, high-risk
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Mar 2011 (actual)
- Primary completion
- 28 Mar 2023 (actual)
- Study completion
- 28 Mar 2023 (actual)
- First posted
- 18 Nov 2010 (estimated)
- Results
- Posted 19 Sep 2024
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 learn if ofatumumab can help to control CLL/SLL that has not yet been treated. The safety of this drug will also be studied.
Detailed description
The Study Drug:
Ofatumumab is designed to bind to the surface of some of the white blood cells (B-cells). It may destroy cancer cells that come from B-cells.
Study Drug Administration:
If you are found to be eligible to take part in this study, you will receive a "loading dose" (a lower dose given first, to lower the risk of a bad reaction to the study drug) of ofatumumab by vein on Day 1 of Cycle 1. The loading dose is less than one-third (1/3) of the normal dose. You will then receive the normal dose over 4 hours 1 time each week (+/- 3 days). The doses may be given more slowly, if your doctor thinks it is needed. All doses of the study drug will be given at M. D. Anderson.
Benadryl (diphenhydramine) and glucocorticoids (steroids such as prednisolone) will be given by vein 30 minutes to 2 hours before you receive ofatumumab to help prevent side effects. You will also take pills of acetaminophen (Tylenol) to help prevent side effects. If no side effects occur, these "pre-medications" may be reduced or not given after the second infusion.
Study Visits:
One (1) time each week, before you receive ofatumumab:
- You will have a physical exam, including measurement of your vital signs.
- You will be asked about how you are feeling, about any side effects you may be having, and about any changes in your health since the last visit.
- Blood (about 2 teaspoons) will be drawn for routine tests.
Length of Study:
You may continue taking the study drug until Day 50, as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, if you develop hepatitis B, or if you decide to go off study.
End-of-Treatment Visit:
On the day of your last treatment or after you stop receiving the study drug for any reason, the following tests and procedures will be performed:
- You will have a physical exam, including measurement of your vital signs.
- You will be asked about how you are feeling, about any side effects you may be having, and about any changes in your health since the last visit.
- Blood (about 2 teaspoons) will be drawn for routine tests.
- If the doctor thinks it is needed, blood (about 2 teaspoons) will be drawn for hepatitis testing.
Follow-Up:
About 3 months (+/- 2 weeks) after the end-of-treatment visit, the following tests and procedures will be performed:
- You will have a physical exam, including measurement of your vital signs.
- You will be asked about how you are feeling, about any side effects you may be having, and about any changes in your health since the last visit.
- You will have a bone marrow aspirate and biopsy, as well as CT scans of the chest, abdomen, and pelvis, to check the status of the disease.
- Blood (about 2 teaspoons) will be drawn for routine tests.
- If the doctor thinks it is needed, blood (about 2 teaspoons) will be drawn for hepatitis testing.
Every 3 months (+/- 4 weeks) after the end-of-treatment visit for 6 months:
- You will have a physical exam, including measurement of your vital signs.
- You will be asked about how you are feeling, about any side effects you may be having, and about any changes in your health since the last visit.
- Blood (about 2 teaspoons) will be drawn for routine tests.
- If the doctor thinks it is needed, blood (about 2 teaspoons) will be drawn for hepatitis testing.
Every year (+/- 4 weeks) after the end-of-treatment visit:
- You will have a physical exam, including measurement of your vital signs.
- You will be asked about how you are feeling, about any side effects you may be having, and about any changes in your health since the last visit.
- Blood (about 2 teaspoons) will be drawn for routine tests.
- You will have a bone marrow aspirate and biopsy, as well as CT scans of the chest, abdomen, and pelvis, to check the status of the disease.
This is an investigational study. Ofatumumab is FDA approved and commercially available for use in the treatment of CLL. The use of ofatumumab as an early treatment for patients with CLL/SLL who have not received other treatment is investigational.
Up to 44 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: OfatumumabLoading dose 300 mg by vein on Day 1 of Cycle 1; and full dose 1000 mg over 4 hours 1 time each week for 7 additional weekly doses (8 doses). |
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 chronic lymphocytic leukemia (CLL)/ small lymphocytic leukemia (SLL), previously untreated, Rai stage 0-ll
- At least 1 of the following high-risk features for previously untreated patients: Rai stage II disease; Rai stage 0-I with disease-related fatigue; Serum beta2M >/= 3 mg/L; Absolute lymphocyte count >/= 25,000/uL; Unmutated IGHV gene or IGHV3-21; ZAP70 positive (>/= 20% by flow cytometry or positive by immunohistochemistry); CD38 positive (>/= 30% by flow cytometry); OR Deletion 11q or 17p by FISH
- ECOG PS </= 2
- Age >/= 18 years
- Patients must have adequate renal and hepatic function (creatinine <2mg/dL, total bilirubin <2mg/dL). Patients with renal or liver dysfunction due to organ infiltration with CLL may be eligible after discussion with the study chairman
Key exclusion criteria (5 listed)
- Presence of 2008 IWCLL/NCI-WG indication for CLL treatment: Constitutional symptoms related to CLL/SLL: Fever > 100.5 degrees F for >/= 2 weeks or night sweats for > 1 mo, both without evidence of infection; Unintentional weight loss of >/= 10% body weight in previous 6 months; Extreme fatigue (ECOG PS > 2; inability to work or perform usual activities); Lymphocyte doubling time of </= 6 months or 50% increase in absolute lymphocyte count within 2 months; Progressive anemia (Rai stage III) or thrombocytopenia (Rai stage IV); Recurrent infections unrelated to hypogammaglobulinemia; Autoimmune phenomenon poorly responsive to corticosteroids or other standard therapy; Massive, progressive or symptomatic lymphadenopathy (> 10 cm in longest diameter) or splenomegaly (> 6 cm below left costal margin)
- Prior or concurrent chemotherapy, radiotherapy, or immunotherapy for CLL
- Active infection (febrile and requiring IV/PO antibiotics), including hepatitis C or HIV, or significant medical illness including renal, cardiac, pulmonary disease, or current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment)
- 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 patient will be excluded. -- Consult with a physician experienced in care and management of subjects with hepatitis B to manage/treat subjects who are anti-HB positive.
- Pregnant or breast feeding females are not eligible.
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: ArzerraLoading first dose 300 mg by vein on Day 1 of Cycle 1; and full dose 1000 mg over 4 hours 1 time each week for 7 additional weekly doses (8 doses). | Drug | Ofatumumab |
Primary outcome
Number of Patients With Complete Response (CR)
Time frame: Up to 12 years
2008 International Workshop on CLL (IWCLL) update of the National Cancer Institute-sponsored Working Group (NCI-WG) outlined specific criteria of Complete Response (CR) for diagnosing CLL. CR is defined as Marrow normocellular, no CLL cells, no B-lymphoid nodules, hemoglobin of ≥11.0 g/dL (untransfused and without erythropoietin), Platelet count of ≥100 × 10^9/L, circulating lymphocyte count normal, no constitutional symptoms, Liver and/or spleen size <13 cm; liver size normal, lymph nodes ≥ 1.5 cm.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- University of Texas MD Anderson Cancer Center WebsiteLink 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. Weirda, BS,MD,PhD study chair
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 Chronic Lymphocytic Leukemia, 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 5 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: finished, as of the sponsor's last update on 19 Sep 2024. 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 19 Sep 2024). 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 Complete Response (CR) (time frame: Up to 12 years). 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 19 Sep 2024.