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LymphomaPhase 2NCT00411086

Rituximab and GM-CSF in Treating Patients With Newly Diagnosed Follicular B-Cell Lymphoma

A Phase 2 study testing Rituximab and Sargramostim (GM-CSF) in people with Lymphoma, run by M.D. Anderson Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Monoclonal antibodies, such as rituximab, 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphoma
What is being tested?
Rituximab and Sargramostim (GM-CSF)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
Nov 2006to Nov 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 histologically confirmed newly diagnosed follicular B-cell lymphoma.
  • Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >/= 20 mm with conventional techniques or as >/= 10 mm with spiral CT scan.
  • Patients should not have received prior therapy of any kind for follicular B-cell lymphoma.
  • Age >/= 18 years. Because no dosing or adverse event data are currently available for the use of rituximab in combination with sargramostim in patients (males or females) <18 years of age, children are excluded from this study.
  • Eastern Cooperative Oncology (ECOG) performance status </= 2 (Karnofsky >/= 60%).
  • Patients must have normal organ and marrow function as defined below: - leukocytes >/= 3,000/microL; - absolute neutrophil count >/= 1,500/microL; - platelets >/= 100,000/microL; -total bilirubin within normal institutional limits; - AST(SGOT)/ALT(SGPT) </= 2.5 X institutional upper limit of normal; - creatinine within normal institutional limits OR - creatinine clearance >/= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
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  • Hemoglobin >/= 8.0 gm/dL
  • The effects of rituximab and sargramostim on the developing human fetus at the recommended therapeutic doses are unknown. For this reason women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
  • Ability to understand and the willingness to sign an informed consent document.

Who cannot join

  • Prior therapy of any kind for follicular B-cell lymphoma.
  • Patients may not be receiving any other investigational agents.
  • Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to rituximab or other agents used in the study.
  • Rituximab is contraindicated in patients with known anaphylaxis or IgE-mediated hypersensitivity to murine proteins. Sargramostim is contraindicated in patients with excessive leukemic myeloid blasts, with known hypersensitivity to GM-CSF or yeast-derived components of the recombinant, and for concomitant (or within 24 hours ± of) uses with chemotherapy or radiotherapy.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
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  • Pregnant women are excluded from this study.
  • Patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy. Therefore, HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions.
  • Patients with evidence of active or prior infection of Hepatitis B are excluded. (Note: Persons vaccinated for Hepatitis B who have positive antibodies are not excluded).

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030-4009

Other trials in United States

About this study

Official title: Single-Arm, Open-Label, Phase II Trial of Rituximab Plus Sargramostim for the Treatment of Newly Diagnosed Follicular B-Cell Lymphoma in Adults

RATIONALE: Monoclonal antibodies, such as rituximab, 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. Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood. Giving rituximab together with GM-CSF may be an effective treatment for follicular B-cell lymphoma.

PURPOSE: This phase II trial is studying the side effects and how well giving rituximab together with GM-CSF works in treating patients with newly diagnosed follicular B-cell lymphoma.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the safety and efficacy of rituximab and sargramostim (GM-CSF), in terms of complete response at 12 weeks, in patients with newly diagnosed follicular B-cell lymphoma.

Secondary

  • Determine the overall response rate in patients treated with this regimen.
  • Determine the progression-free survival at 3 years in patients treated with this regimen.
  • Determine the adverse event profile of this regimen in these patients.
  • Determine the survival of patients treated with this regimen.
  • Determine the effect of Fc gamma receptor polymorphism on response rate and time to progression in patients treated with this regimen.

OUTLINE: This is an open-label, multicenter study.

Patients receive rituximab IV on days 1, 8, 15, and 22 and sargramostim (GM-CSF) subcutaneously on days 1, 3, and 5. Treatment with GM-CSF repeats weekly for up to 8 weeks in the absence of disease progression or unacceptable toxicity.

Patients undergo blood collection at baseline for correlative laboratory studies of Fc-gamma receptor RIIIa 158 polymorphism.

After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 1 year.

Conditions
Lymphoma
Being tested
Rituximab, Sargramostim (GM-CSF)
Keywords
contiguous stage II grade 1 follicular lymphoma, contiguous stage II grade 2 follicular lymphoma, contiguous stage II grade 3 follicular lymphoma, noncontiguous stage II grade 1 follicular lymphoma, noncontiguous stage II grade 2 follicular lymphoma, noncontiguous stage II grade 3 follicular lymphoma, stage I grade 1 follicular lymphoma, stage I grade 2 follicular lymphoma, stage I grade 3 follicular lymphoma, stage III grade 1 follicular lymphoma, stage III grade 2 follicular lymphoma, stage III grade 3 follicular lymphoma, stage IV grade 1 follicular lymphoma, stage IV grade 2 follicular lymphoma, stage IV grade 3 follicular lymphoma, Granulocyte-Macrophage Colony Stimulating Factor, GM-CSF, Rituximab, Rituxan
Medical subject headings
Lymphoma, Lymphoma, Follicular

What participants receive

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

  • RituximabBiological

    Also called Rituxan

    375 mg/m^2 By Vein Weekly on Days 1, 8, 15, and 22.

  • Sargramostim (GM-CSF)Biological

    Also called Granulyte, Leukene, Granulocyte-Macrophage Colony Stimulating Factor

    250 mcg subcutaneously three times weekly for 8 weeks, starting at least 1 hour before first dose of rituximab.

Study groups in NCT00411086
Study groupRoleWhat they receive
Rituximab + GM-CSFExperimentalRituximab 375 mg/m^2 By Vein Weekly on Days 1, 8, 15, and 22. Sargramostim (GM-CSF) 250 mcg subcutaneously three times weekly for 8 weeks, starting at least 1 hour before first dose of rituximab.
Receives: Biological: Rituximab; Biological: Sargramostim (GM-CSF)

What is being measured

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

  1. Complete Response Rate

    Complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy, and normalization of those biochemical abnormalities [e.g., lactate dehydrogenase (LDH)] definitely assignable to NHL.

    Response and progression evaluated using the International Criteria proposed in the Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas.

    Measured: 12 weeks (3 months)

Secondary outcomes (2)

  1. Median Progression-Free Survival (PFS)

    PFS is defined as the duration of time from start of treatment to time of progression; and, for PFS time calculated from chemo start date to progression date or death date, whichever happened first. Patients were censored at the last follow-up date if neither progression nor death occurred. Response and progression evaluated using the International Criteria proposed in the Report of an International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas. The Kaplan-Meier method was used for time-to-event analysis including PFS.

    Measured: 3 years

  2. Overall Response (OR) Rate

    OS defined as percentage of participants alive at a certain period following start of chemotherapy treatment.

    Measured: 3 Months

Timeline

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

  1. First posted13 Dec 2006 (estimated)
  2. Study startNov 2006
  3. Primary completionNov 2016
  4. Study completionNov 2016

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
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00411086
Sponsor's protocol ID
MDA-2006-0260
Other IDs
P30CA016672, MDA-2006-0260, CDR0000521620, NCI-2009-00187
Status last verified
Nov 2017
First submitted
11 Dec 2006
Last updated
5 Dec 2017
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Rituximab and Sargramostim (GM-CSF) in people with 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 9 inclusion and 9 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 5 Dec 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 5 Dec 2017). 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?

Complete Response Rate (time frame: 12 weeks (3 months)). 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 NCT00411086.

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 5 Dec 2017.

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