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Follicular LymphomaPhase 2NCT01389076

Trial of Low-Dose Methotrexate and I 131 Tositumomab for Previously Untreated, Advanced-Stage, Follicular Lymphoma

A Phase 2 study testing Bexxar and Low Dose Methotrexate in people with Follicular Lymphoma, run by University of Michigan Rogel Cancer Center 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

Patients with a type of non-Hodgkin lymphoma, called follicular lymphoma and have not yet had previous systemic treatment, such as chemotherapy or immunotherapy will be invited to participate. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Follicular Lymphoma
What is being tested?
Bexxar and Low Dose Methotrexate
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteUnited States
Study dates
Jul 2011to Jun 2016
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 a histologically-confirmed diagnosis of follicular non-Hodgkin's B-cell lymphoma, grade 1-2 (grade 1 or grade 2 by WHO classification prior to 2009).
  • Patients must have Ann Arbor Stage III or IV extent of disease after complete staging.
  • Patients must have a willingness and ability to follow prescribed radiation precautions
  • Patients must not have had any previous treatment for low-grade lymphoma including chemotherapy or radiation. They may be newly diagnosed or observed without treatment after diagnosis. Symptomatic and asymptomatic patients will be eligible.
  • Patients must have a performance status of 0-2 on the Eastern Cancer Oncology Group (ECOG) scale and an anticipated survival of at least 3 months.
  • Patients must have an absolute neutrophil count >1500 cells/mm3 and a platelet count >100,000 cells/mm3 within 14 days of study entry. These blood counts must be sustained without support of hematopoietic cytokines or transfusion of blood products.
  • Patients must have adequate renal function (defined as serum creatinine <2.0) and hepatic function (defined as total bilirubin <1.5 x ULN and Aspartate Aminotransferase (AST) <3 x ULN) within 14 days of study entry.
  • Patients must have bi-dimensionally measurable disease.

Who cannot join

  • Patients with follicular Grade 3a or 3b by WHO Classification.
  • Patients with evidence of active infection requiring IV antibiotics at the time of study entry.
  • Patients with New York Heart Association Class III or IV heart disease or other serious illness that would preclude evaluation.
  • Patients with active obstructive hydronephrosis.
  • Patients with prior malignancy other than lymphoma, except for adequately treated skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for 5 years.
  • Patients with known HIV infection.
Show all 13Show fewer
  • Patients with known brain or leptomeningeal metastases.
  • Patients who are pregnant or nursing. Patients of childbearing potential must undergo a pregnancy test within 7 days of study entry and methotrexate is not to be administered until a negative result is obtained. Males and females must agree to use effective contraception for 6 months following the radioimmunotherapy.
  • Patients with previous allergic reactions to iodine. This does not include reacting to IV iodine-containing contrast materials.
  • Patients with previous allergic reactions to methotrexate.
  • Patients who were previously given any monoclonal antibody, regardless of species, for any condition.
  • Detectable serum levels of HAMA.
  • Patients who are concurrently receiving either approved or non-approved (through another protocol) anti-cancer drugs or biologics.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Michigan

    Ann Arbor, Michigan, 48109

Other trials in United States

About this study

Official title: Phase II Trial of Low-Dose Methotrexate and Iodine I 131 Tositumomab for Previously Untreated, Advanced-Stage, Follicular Lymphoma

Patients with a type of non-Hodgkin lymphoma, called follicular lymphoma and have not yet had previous systemic treatment, such as chemotherapy or immunotherapy will be invited to participate. This research study is being conducted in order to evaluate the combination of lowdose methotrexate and Iodine I 131 tositumomab (Bexxar) with regards to whether the combination will reduce the occurrence of the HAMA (Human Anti-Mouse Antibody) response. HAMA is an immune reaction against the tositumomab protein. Symptoms arising from HAMA can range from a mild form, like a rash, to a more extreme and possibly life-threatening level. HAMA can also decrease the effectiveness of the treatment, or create a future reaction if a patient is given another treatment containing mouse antibodies. In addition to evaluating the occurrence of HAMA, this research study will also look at the short and long-term effectiveness of this combination in the treatment of lymphoma, as well as its safety.

Read the detailed description

This is a single-arm, single institution, Phase II study to test the use of low-dose methotrexate in combination with I-131 tositumomab for its ability to lower the rate of (human anti-mouse antibody) HAMA formation in patients with previously untreated low-grade follicular lymphoma. Low-dose methotrexate will be given beginning 3 weeks prior to the first infusion of I-131 tositumomab (4 weekly doses) and continued for 6 weeks (10 total doses), the period of time during which the development of HAMA is most detrimental. A total of 61 patients will be enrolled. The primary endpoint of the study is the determination of the rate of HAMA conversion within the first seven weeks following treatment. The secondary endpoints include response rates, progression-free and overall survival, and safety.

Being tested
Bexxar, Low Dose Methotrexate
Keywords
Previously Untreated, Advanced-Stage, Follicular Lymphoma
Medical subject headings
Lymphoma, Follicular

What participants receive

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

  • BexxarDrug

    Also called Iodine I 131 tositumomab

    Iodine I 131 tositumomab (Bexxar) is a radioimmunotherapy (RIT) drug. RIT is a treatment strategy designed to target radiation specifically to cancer cells by attaching a radioactive atom to a monoclonal antibody, an immune system protein that binds to a particular protein. The Iodine I 131 tositumomab (Bexxar) therapeutic regimen is delivered in two sets of intravenous infusions given about 7 days apart. Nonradioactive Tositumomab is given before both the "dosimetric" infusion and the "therapeutic" infusion to improve distribution of these doses throughout the body.

  • Low Dose MethotrexateDrug

    Methotrexate is an antifolate drug. It interferes with cells' ability to copy their DNA. This mainly affects cells that are dividing frequently, such as immune system cells and cancer cells. Methotrexate will be used in this study to try to prevent the occurrence of HAMA by limiting your body's ability to produce anti mouse antibodies.

Study groups in NCT01389076
Study groupRoleWhat they receive
Treatment armExperimentalLow dose methotrexate and Bexxar
Receives: Drug: Bexxar; Drug: Low Dose Methotrexate

What is being measured

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

  1. Rate of Early Onset HAMA (Human Anti-mouse Antibody) Conversion Following Treatment

    The percentage of patients that experience early onset HAMA conversion following treatment. Early-onset HAMA is defined as antimouse antibody levels (in blood serum) of at least 5 times the level of detection, occurring at or prior to the 7th week of I-131 tositumomab therapy.

    Measured: 7 weeks

Secondary outcomes (4)

  1. Percentage of Participants That Respond to Treatment

    The overall response rate (PR [partial response] + CR [complete response]) was determined.

    Partial response is defined as the regression of measurable disease with no new sites of disease.

    Complete response is defined as the disappearance of all evidence of disease.

    Measured: 2 years

  2. The Percentage of Participants Alive at 2 Years

    Overall survival was examined at 2 years

    Measured: 2 years

  3. Median Progression Free Survival (PFS) Time

    The median time patients survived without progression.

    Measured: 2 Years

  4. Number of Participants That Experienced SAEs During Treatment.

    Measured: Up to week 13

Timeline

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

  1. First posted7 Jul 2011 (estimated)
  2. Study startJul 2011
  3. Primary completionFeb 2014
  4. Study completionJun 2016

Why it stopped: Bexxar isn't being produced by the manufacturer as of Feb. 2014

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
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01389076
Sponsor's protocol ID
UMCC 2010.098
Other IDs
HUM00043235
Status last verified
Dec 2016
First submitted
5 Jul 2011
Last updated
30 Jan 2017
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bexxar and Low Dose Methotrexate in people with Follicular Lymphoma, run by University of Michigan Rogel 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 8 inclusion and 13 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 Jan 2017. 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 12 Jul 2016). 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?

Rate of Early Onset HAMA (Human Anti-mouse Antibody) Conversion Following Treatment (time frame: 7 weeks). 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 NCT01389076.

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 Jan 2017.

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