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Lymphoma, Non-HodgkinPhase 2NCT01263418

Ofatumumab In Older Patients With Untreated Low Or Intermediate Risk Indolent B-Cell Lymphomas

A Phase 2 study testing Ofatumumab in people with Lymphoma, Non-Hodgkin and Lymphoma, Follicular, run by UNC Lineberger Comprehensive Cancer Center.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This research study will only include two types of non-Hodgkin Lymphoma (NHL), follicular lymphoma or marginal zone lymphoma and participants will be age 70 or older. The purpose of this research study is to learn about the safety of the treatment with the drug ofatumumab to find out what effects, both good and bad… Read more about this study

Who is it for?
Ages 70 years and older
What is being tested?
Ofatumumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Jun 2011to Jan 2018
Phase
Phase 2
Are there results?
None posted in the registry

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 70 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Stage II, III, or IV follicular or marginal zone B-cell CD20+ lymphomas not previously treated with systemic therapy
  • Low/intermediate risk grade 1 or 2 follicular NHL or marginal zone lymphoma defined by 2004 Follicular Lymphoma International Prognostic Index (FLIPI) scores
  • Measurable disease as assessed by 2 dimensional measurement by CT and/or by bone marrow histopathology.
  • Age ≥ 70 years at time of informed consent
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  • Life expectancy of at least 3 months
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  • Documented negative serologic testing for human immunodeficiency virus (HIV)
  • Documented negative serologic testing for Hepatitis B (HB); this is defined as negative for HBsAg;
  • If negative for HBsAg but HBcAb positive (regardless of HBsAb status), an hepatitis B virus (HBV) DNA test will be performed and must be negative for eligibility. Those with negative HBV DNA may be included but must undergo HBV DNA PCR testing every 2 months (see Time and Events table). Prophylactic antiviral therapy may be initiated at the discretion of the investigator in these patients.
  • Adequate bone marrow function (without transfusion support within four weeks of screening) as demonstrated by:
  • Hemoglobin ≥ 8 g/dL
  • Absolute neutrophil count (ANC) ≥ 1,000 cells/mm3
  • Platelet count ≥ 50,000/mm3
  • Adequate hepatic and renal function as demonstrated by:
  • Aspartate aminotransferase (AST/ALT) ≤ 2.5 × upper limit of normal (ULN)
  • Total serum bilirubin ≤ 1.5 × ULN
  • Alkaline phosphatase ≤ 2.5 × ULN
  • Serum creatinine ≤ 1.5 × ULN
  • If sexually active male with female partner of reproductive capability, has agreed to use a medically accepted form of contraception from time of enrollment to completion of initial follow-up study visit. Adequate contraception is defined as hormonal birth control, intrauterine device, double barrier method, or total abstinence.
  • Signed an institutional review board (IRB)-approved informed consent document for this protocol

Who cannot join

  • Prior therapies for lymphoma except involved field radiation therapy
  • Prior anti-CD20 monoclonal antibody or alemtuzumab within 3 months prior to first infusion of ofatumumab for any reason
  • Evidence of transformation to aggressive lymphoma
  • More than 10 x 109/L circulating CD20+ lymphoma cells
  • History of previous allergic reactions to compounds of similar biological or chemical composition as ofatumumab
  • Medical or other condition that would represent an inappropriate risk to the patient or would likely compromise achievement of the primary study objective
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  • Other past or current malignancies with the exception of:
  • Patients who have been free of malignancy for at least 5 years
  • Completely resected, non-melanoma skin cancer
  • Successfully treated in situ carcinoma
  • Patients who have current active hepatic or biliary disease (with exception Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment)
  • Treatment with any known non-marketed drug substance or experimental therapy within 5 terminal half lives or 4 weeks prior to first infusion of ofatumumab, whichever is longer, or currently participating in any other interventional clinical study
  • Chronic or current infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment such as, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis, tuberculosis and active Hepatitis C.
  • History of significant cerebrovascular disease in the past 6 months or ongoing event with active symptoms or sequelae
  • Clinically significant cardiac disease including unstable angina, acute myocardial infarction within six months prior to first infusion of ofatumumab, congestive heart failure (NYHA III-IV), and arrhythmia (unless controlled by therapy), with the exception of extra systoles or minor conduction abnormalities.
  • Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease which in the opinion of the investigator may represent a risk for the patient.
  • Positive serology for Hepatitis B (HB) defined as a positive test for HBsAg. In addition, if negative for HBsAg but HBcAb positive (regardless of HBsAb status), a HBV DNA test will be performed and if positive the patient will be excluded.

About this study

Official title: A Phase II Trial Of Ofatumumab In Older (≥70 Years) Patients With Previously Untreated Low Or Intermediate Risk Indolent B-Cell Lymphomas

This research study will only include two types of non-Hodgkin Lymphoma (NHL), follicular lymphoma or marginal zone lymphoma and participants will be age 70 or older.

The purpose of this research study is to learn about the safety of the treatment with the drug ofatumumab to find out what effects, both good and bad this treatment has on lymphoma. Ofatumumab is a monoclonal antibody. Monoclonal antibodies are being used to treat some types of cancer. Monoclonal antibodies are a type of protein made in a laboratory that can bind substances in the body including cancer cells. Ofatumumab binds to the protein called CD20, which is found on B-cells and lymphoma cells.

Read more

The study drug, Ofatumumab, is approved by the United States Food and Drug Administration (FDA) for treatment of other types of blood cancer and is not approved for use in patients with non-Hodgkin Lymphoma. The use of ofatumumab in this study is considered investigational.

In addition to learning about ofatumumab, the researchers are interested in learning about how this cancer treatment affects daily activities. Participants will be asked to complete a Geriatric Assessment (GA). GAs are designed to gather information on memory, nutritional status, mental health, and level of social support. This assessment will help the health care team understand a participant's "functional age" as compared to a participant's actual age.

The researchers also want to collect blood samples to study molecules in follicular lymphoma cells called 'biomarkers' to learn about how the lymphoma responds to therapy. A biomarker is a molecule (for example, DNA or protein) found in the blood or tissues that is a marker for disease. In this study, the investigators will measure the changes of the biomarker called bcl-2. This biomarker research will only be in subjects with follicular lymphoma.

Read the detailed description

This multicenter Phase II clinical study will investigate the overall response rate (ORR) after 2 months of therapy with weekly ofatumumab in older (≥70 years of age) patients with previously untreated low or intermediate risk indolent NHL (n=37). Secondary objectives include progression free survival (PFS) at 2 years, and an evaluation of the toxicity and tolerability of ofatumumab in this population.

We will also evaluate molecular response to ofatumumab by performing PCR analysis for BCL2/IgH from the peripheral blood.

We will conduct an exploratory analysis of the minimum observed serum concentration (Cmin) of ofatumumab prior to the last dose and correlate this level with ORR.

This trial includes administration of a Geriatric Assessment (GA) tool which patients will be asked to complete serially during the trial.

Being tested
Ofatumumab
Keywords
Follicular Lymphoma, Marginal Zone Lymphoma, Non-Hodgkins Lymphoma, Elderly, Newly Diagnosed, Lineberger Comprehensive Cancer Center, University of North Carolina, Ofatumumab, Arzerra, Phase 2, Geriatric, Lymphoma
Medical subject headings
Lymphoma, Non-Hodgkin, Lymphoma, Follicular, Lymphoma, B-Cell, Marginal Zone, Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OfatumumabDrug

    Also called ARZERRA, (BLA) 125326

    Intravenous; Dosage: 1000mg; Frequency: one time per week; Duration: 8 weeks

Study groups in NCT01263418
Study groupRoleWhat they receive
OfatumumabExperimentalNot described
Receives: Drug: Ofatumumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To determine overall response rates (ORR) following ofatumumab treatment in older (≥ 70 years old) patients with previously untreated low or intermediate risk indolent NHL

    The ORR will be evaluated as the rate of complete responses (CR) + partial responses (PR) as defined by the Revised Response Criteria for Malignant Lymphoma (RRCML)

    Measured: 2 years

Secondary outcomes (4)

  1. To determine the complete response rate (CR) following ofatumumab treatment in older patients without prior systemic therapy for low or intermediate risk indolent NHL

    Measured: 2 years

  2. To evaluate the toxicity and tolerability of ofatumumab treatment in the study population

    Measured: 2 years

  3. Estimate progression free survival (PFS) at 2 years after ofatumumab treatment

    PFS is defined as the time from study entry until lymphoma progression or death as a result of any cause.

    Measured: 4 years

  4. Evaluate molecular response to ofatumumab therapy by performing PCR analysis for BCL2/IgH from the peripheral blood at baseline and 3 months from initiation of treatment

    Molecular response is defined as the percentage of patients with detectable BCL2 PCR at baseline who convert from BCL2 PCR-detectable to undetectable disease status in the peripheral blood.

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Dec 2010 (estimated)
  2. Study startJun 2011
  3. Primary completionJan 2016 (estimated)
  4. Study completionJan 2018 (estimated)

Why it stopped: No patients enrolled and funding has been withdrawn.

Resources

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01263418
Sponsor's protocol ID
LCCC 1018
Other IDs
IRB # 10-1910
Status last verified
Oct 2015
First submitted
16 Dec 2010
Last updated
12 Oct 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ofatumumab in people with Lymphoma, Non-Hodgkin and Lymphoma, Follicular, run by UNC Lineberger Comprehensive Cancer Center.

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 20 inclusion and 17 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: withdrawn, as of the sponsor's last update on 12 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

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?

The study was withdrawn before enrolling participants, so there are no results.

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?

To determine overall response rates (ORR) following ofatumumab treatment in older (≥ 70 years old) patients with previously untreated low or intermediate risk indolent NHL (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01263418.

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 12 Oct 2015.

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