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Recurrent Adult Diffuse Large Cell LymphomaPhase 2NCT01397591

Ofatumumab and Bortezomib in Subjects With Relapsed CD20+Diffuse Large B Cell, Follicular, or Mantle Cell Lymphoma

A Phase 2 study testing Ofatumumab and Bortezomib in people with Recurrent Adult Diffuse Large Cell Lymphoma and Recurrent Grade 1 Follicular Lymphoma, run by OHSU Knight Cancer Institute at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This phase II trial studies how well giving ofatumumab together with bortezomib works in treating patients with relapsed diffuse large B cell lymphoma (DLBCL), follicular lymphoma (FL), or mantle cell lymphoma (MCL). Monoclonal antibodies, such as ofatumumab, can block cancer growth in different ways. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Ofatumumab and Bortezomib
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
1 siteUnited States
Study dates
Oct 2011to Jul 2013
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

  • Patients must have biopsy sample obtained within 6 months of study entry that:
  • Is histologically confirmed DLBCL, MCL or FL, by an Oregon Health and Science University (OHSU) hematopathologist
  • Retains expression of CD20+
  • Patients must be refractory to or have recurrent disease after prior rituximab containing treatment; relapse or progression is defined according the International Working Group (IWG) response criteria
  • FL patients must have disease-related symptoms, cytopenias, threatened end-organ function, bulky or progressive disease, or it is the patient's preference to be treated
  • DLBCL and MCL patients must be either transplant ineligible or have refused high dose therapy
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  • Patients must have radiographically measurable disease, as defined by the IWG criteria; the same method of assessment used to measure each lesion at baseline must be used for all subsequent tumor measurements throughout the study
  • There is no limit to the number of prior treatments
  • Eastern Cooperative Oncology Group (ECOG) performance status =< 2
  • Absolute neutrophil count >= 1.0 K/mm^3
  • Platelets >= 50 K /mm^3
  • Total bilirubin =< 1.5 x normal institutional limits, unless secondary to Gilbert's disease
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase (SGOT))/alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase (SGPT)) =< 2.5 x institutional upper limit of normal (ULN)
  • Alkaline Phosphatase < 2.5 times ULN (unless due to disease involvement of the liver or bone marrow)
  • Patients must be able to comply with study procedures and follow-up examinations
  • Women of childbearing potential (not surgically sterile or < 12 months naturally post-menopausal) must be willing to use medically accepted method of contraception for the duration and 6 months following the end of the treatment; acceptable methods of contraception include abstinence, barrier method with spermicidal or hormonal contraceptive (oral, transdermal, implanted and injected) in conjunction with a barrier method
  • Men who are not surgically sterile must practice abstinence or use a barrier method of birth control for the duration and 6 months following the end of treatment
  • Patients must have the ability to understand and the willingness to sign a written informed consent document

Who cannot join

  • Subjects who have current active hepatic or biliary disease (with the exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment)
  • Patients who have had chemotherapy, antibody or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C); corticosteroids for symptom control are allowed up to 7 days of starting protocol treatment
  • Patients may not have received any other investigational agents within 4 weeks, or may not be currently participating in any other interventional clinical study
  • Prior treatment with ofatumumab or bortezomib
  • Prior treatment with anti-CD20 monoclonal antibody or alemtuzumab within 3 months prior to start of therapy
  • Diagnosis of another malignancy, unless the patient has been disease-free or at least 5 years following the completion of curative intent therapy with the following exceptions: patients with treated non-melanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia, regardless of the disease-free duration, are eligible for this study if definitive treatment for the condition has been completed; patients with organ-confined prostate cancer with no evidence of recurrent or progressive disease based on prostate-specific antigen (PSA) values are also eligible for this study if hormonal therapy has been initiated or a radical prostatectomy has been performed
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  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to ofatumumab or bortezomib
  • Peripheral neuropathy or neuropathic pain of Grade 2 or greater
  • Chronic or current infectious disease requiring systemic antibiotics, antifungal, or anti-viral treatment such as, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis and tuberculosis
  • 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 randomization, congestive heart failure (New York Heart Association (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
  • Pregnant or breast feeding women
  • Known human immunodeficiency virus (HIV) infection
  • Positive serology for Hepatitis B (HB) defined as a positive test for HB surface antigen (HBsAg); in addition, if negative for HBsAG but HB core antibody (HBcAb) positive (regardless of HBsAb status), a HB deoxyribonucleic acid (DNA) test will be performed; if positive the subject will be excluded
  • Active hepatitis C infection (HC) defined as a positive test for hepatitis C antibody (HCAb), in which case the investigator should reflexively perform a HC Recombinant Immunoblot assay (RIBA) on the same sample to confirm the result
  • Known lymphoma involvement of the central nervous system (CNS)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • OHSU Knight Cancer Institute

    Portland, Oregon, 97239

Other trials in United States

About this study

Official title: Phase II Trial of Ofatumumab and Bortezomib in Subjects With Relapsed Cluster of Differentiation Antigen 20 (CD20)+ Diffuse Large B Cell Lymphoma, Follicular Lymphoma, or Mantle Cell Lymphoma

This phase II trial studies how well giving ofatumumab together with bortezomib works in treating patients with relapsed diffuse large B cell lymphoma (DLBCL), follicular lymphoma (FL), or mantle cell lymphoma (MCL). Monoclonal antibodies, such as ofatumumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving ofatumumab together with bortezomib may help kill more cancer cells

Read the detailed description

PRIMARY OBJECTIVES:

  1. To determine the efficacy, as measured by overall response (complete response (CR) + partial response (PR)) of ofatumumab in combination with bortezomib in subjects with relapsed cluster of differentiation (CD)20+ DLBCL, FL or MCL.

SECONDARY OBJECTIVES:

  1. To explore duration of efficacy of ofatumumab in combination with bortezomib in the same population as measured by progression free survival (PFS), overall survival (OS) and disease free survival (DFS).

II. To assess response as compared to prior treatment. III. To assess the safety and tolerability of ofatumumab in combination with bortezomib in the same patient population.

TERTIARY OBJECTIVES:

  1. Correlation of trough ofatumumab blood levels to response. II. Correlation fragment crystallizable receptor (FcR) gamma 3 allotype and response.

OUTLINE:

Patients receive ofatumumab intravenously (IV) over 2.5 hours on days 1 and 8 of course 1, and day 1 of all subsequent courses. Patients also receive bortezomib IV over 3-5 seconds on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment patients are followed up every 3 months for 2 years.

Being tested
Ofatumumab, Bortezomib
Medical subject headings
Lymphoma, Large B-Cell, Diffuse, Lymphoma, Follicular, Lymphoma, Mantle-Cell

What participants receive

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

  • OfatumumabBiological

    Also called Arzerra, HuMax-CD20

    Given intravenously

  • BortezomibDrug

    Also called LDP 341, MLN341, VELCADE

    Given intravenously

Study groups in NCT01397591
Study groupRoleWhat they receive
Ofatumumab with BortezomibExperimentalOfatumumab was given intravenously on cycle 1 day 1 at a dose of 300mg, followed by a cycle 1 day 8 dose of 1000mg. During cycles 2 through cycle 6, Ofatumumab was given at a dose of 1000mg on day 1 of each cycle, with no dosing on any other day of the cycle. Bortezomib was given intravenously at a dose of 1.6mg/m2 on days 1, 8, and 15 of each cycle, following the Ofatumumab infusion, if given.
Receives: Biological: Ofatumumab; Drug: Bortezomib

What is being measured

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

  1. Response Rate of Ofatumumab in Combination With Bortezomib in Patients With Relapsed CD20+ (Cluster of DIfferentiation Antigen 20) Diffuse Large B Cell Lymphoma, Follicular Lymphoma, or Mantle Cell Lymphoma

    Based on International Working Group (IWG) criteria, recorded in four categories: Complete Response (CR), disappearance of all evidence of disease; Partial Response (PR), regression of measurable disease and no new sites of disease; Progressive Disease (PD), Any new lesion or increase by >= 50% of previously involved sites from nadir. Stable Disease (SD), failure to attain CR/PR or PD. A response is defined to be either CR/PR. A failure in response includes SD/PD.

    Measured: Every 2 cycles during treatment and then every 3 months for 2 years

Secondary outcomes (4)

  1. Overall Survival

    This outcome measure is defined as the time from initiation of treatment to death due to any cause.

    Measured: Up to every 3 months for 2 years

  2. Progression Free Survival

    This outcome measure is defined as the length of time after treatment during which the patient survives with no sign of the disease.

    Measured: Up to every 3 months for 2 years

  3. Disease Free Survival

    The period of time between complete remission and recurrence of disease.

    Measured: Up to every 3 months for 2 years

  4. Number of Participants With Adverse Events (Toxicity)

    Toxicities and adverse experiences will be assessed at each visit using the NCI Common Toxicity Criteria for Adverse Events v4.0 Interim analyses on toxicity will be implemented based on the toxicity endpoints of the first 6 patients, and will be conducted sequentially 4 weeks after the treatment of each patient, or when serious toxicity has been observed for the patient, whichever comes earlier. we assume a non-informative prior distribution (Beta (0.001, 0.001)) for toxicity rate, and compute the posterior distribution of toxicity rate sequentially.

    Measured: Days 1, 8, and 15 of each course and 4-6 weeks after final treatment

Timeline

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

  1. First posted19 Jul 2011 (estimated)
  2. Study startOct 2011
  3. Primary completionMay 2013
  4. Study completionJul 2013

Why it stopped: Study closed by PI due to lower than expected accrual.

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01397591
Sponsor's protocol ID
IRB00007042
Other IDs
NCI-2011-01032, OFT113735
Status last verified
Jul 2014
First submitted
13 Jul 2011
Last updated
30 Jul 2014
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ofatumumab and Bortezomib in people with Recurrent Adult Diffuse Large Cell Lymphoma and Recurrent Grade 1 Follicular Lymphoma, run by OHSU Knight Cancer Institute 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 18 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: stopped early, as of the sponsor's last update on 30 Jul 2014. 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 30 Jul 2014). 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?

Response Rate of Ofatumumab in Combination With Bortezomib in Patients With Relapsed CD20+ (Cluster of DIfferentiation Antigen 20) Diffuse Large B Cell Lymphoma, Follicular Lymphoma, or Mantle Cell Lymphoma (time frame: Every 2 cycles during treatment and then every 3 months for 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 NCT01397591.

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 30 Jul 2014; AzTrials last refreshed its copy on 6 Nov 2026.

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