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Contiguous Stage II Grade 1 Follicular LymphomaPhase 2NCT01682044

Pegfilgrastim and Rituximab in Treating Patients With Untreated, Relapsed, or Refractory Follicular Lymphoma, Small Lymphocytic Lymphoma, or Marginal Zone Lymphoma

A Phase 2 study testing pegfilgrastim, rituximab and flow cytometry in people with Contiguous Stage II Grade 1 Follicular Lymphoma and Contiguous Stage II Grade 2 Follicular Lymphoma, run by Roswell Park Cancer Institute 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

This phase II trial studies the side effects and how well giving pegfilgrastim together with rituximab works in treating patients with untreated, relapsed, or refractory follicular lymphoma, small lymphocytic lymphoma (SLL), or marginal zone lymphoma (MZL). Read more about this study

Who is it for?
Ages 19 years and older
What is being tested?
pegfilgrastim, rituximab and flow cytometry
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
17 Apr 2007to 22 Dec 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 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Untreated or relapsed/refractory follicular, SLL or MZL (i.e. no limit to number of prior treatments as long as patients meet other study criteria)
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Measurable tumor size (at least one node measuring 4 cm^2 in bidimensional measurement)
  • Expected survival of > 6 months
  • Prior rituximab or other monoclonal immunotherapy permitted and eligible for rituximab monotherapy
  • Full recovery from any significant toxicity associated with prior surgery, radiation therapy, chemotherapy, or immunotherapy
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  • Absolute neutrophil count > 1.0 x 10^9/L
  • Platelets > 50 x 10^9/L
  • Patients may receive erythropoietin growth factors to maintain adequate hemoglobin levels (>= 8.0 mg/dl)
  • Creatinine < 1.5 x upper normal levels (UNL)
  • Total bilirubin < 1.5 mg/dL (> 25.65 umol/L)
  • Aspartate aminotransferase < 5 x UNL
  • Alkaline phosphatase < 5 x UNL
  • Informed consent approved in institutional review board (lRB)
  • CD20+ B-cell lymphoma

Who cannot join

  • Prior history of human immunodeficiency virus (HIV)-positivity (routine HIV testing is required pretreatment)
  • Serious non-malignant disease (e.g. active uncontrolled bacterial, viral, or fungal infections) or other conditions which, in the opinion of the principal investigator would compromise other protocol objectives
  • Presence of central nervous system (CNS) lymphoma
  • Chemotherapy within 4 weeks of the first scheduled study treatment
  • Another primary malignancy (other than squamous or basal cell carcinoma of the skin or in-situ carcinoma of the cervix) for which the patient has not been disease-free for at least five years
  • Major surgery, other than diagnostic surgery, within four weeks
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  • Patients with non-Hodgkin lymphoma (NHL) other than relapsed/refractory follicular, MZL or SLL
  • Patients must not have a history of cardiac disease, defined as New York Heart Association Class II or greater or clinical evidence of congestive heart failure
  • Concurrent use of other investigational agents
  • Pregnant or breast feeding
  • Subjects of reproductive potential who are not using adequate contraceptive precautions, in the judgment of the investigator
  • Known hypersensitivity to any recombinant E coli-derived product, murine proteins, or any components of the study medications
  • Concerns for the subject's compliance with the protocol
  • Any premalignant myeloid condition or any malignancy with myeloid characteristics (e.g. myelodysplastic syndromes, acute or chronic myelogenous leukemia)
  • Patient is currently enrolled in, or has not yet completed at least 30 days since ending another investigational device or drug trial

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

Other trials in United States

About this study

Official title: Phase II Clinical Trial of Rituximab in Combination With Pegfilgrastim in Patients With Indolent B-Cell (CD-20-Positive) Lymphoma

This phase II trial studies the side effects and how well giving pegfilgrastim together with rituximab works in treating patients with untreated, relapsed, or refractory follicular lymphoma, small lymphocytic lymphoma (SLL), or marginal zone lymphoma (MZL). Colony-stimulating factors, such as pegfilgrastim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of therapy. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer to grow and spread. Others find cancer cells and help kill them or tumor cancer-killing substances to them. Giving pegfilgrastim together with rituximab may kill more cancer cells

Read the detailed description

PRIMARY OBJECTIVES:

  1. To evaluate the safety of Pegfilgrastim in combination with rituximab in patients with untreated or relapsed/refractory follicular, SLL or MZL.

SECONDARY OBJECTIVES:

  1. To evaluate the efficacy (including overall response rate and durability of objective responses) of Pegfilgrastim in combination with rituximab in patients with untreated or relapsed/refractory follicular, SLL or MZL.

II. To evaluate functional and phenotypic characteristics of host neutrophils undergoing treatment with Pegfilgrastim and rituximab.

III. To evaluate changes in cluster of differentiation (CD)20 antigen expression and density of expression in patients receiving Pegfilgrastim and rituximab.

IV. To evaluate changes in serum levels of tumor necrosis factor (TNF), interferon alpha (INFalpha) and free radical levels in patients undergoing treatment with Pegfilgrastim and rituximab.

OUTLINE:

Patients receive pegfilgrastim subcutaneously (SC) followed by rituximab intravenously (IV) 3 days later in weeks 1, 3, 5, 7, 15, 23, 31, and 39. Treatment continues in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 4 months for 1 year, every 6 months for 2 years, and then yearly for 1 year.

Medical subject headings
Lymphoma, B-Cell, Marginal Zone, Lymphoma, Follicular, Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

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

  • pegfilgrastimBiological

    Also called Filgrastim SD-01, GCSF-SD01, Neulasta, SD-01 sustained duration G-CSF

    Given SC

  • rituximabBiological

    Also called IDEC-C2B8, IDEC-C2B8 monoclonal antibody, Mabthera, MOAB IDEC-C2B8

    Given IV

  • flow cytometryOther

    Correlative studies

  • biopsyProcedure or surgery

    Also called biopsies

    Correlative studies

  • immunohistochemistry staining methodOther

    Also called immunohistochemistry

    Correlative studies

  • western blottingGenetic

    Also called Blotting, Western, Western Blot

    Correlative studies

Study groups in NCT01682044
Study groupRoleWhat they receive
Treatment (colony-stimulating factor and monoclonal antibody)ExperimentalPatients receive pegfilgrastim SC followed by rituximab IV 3 days later in weeks 1, 3, 5, 7, 15, 23, 31, and 39. Treatment continues in the absence of disease progression or unacceptable toxicity.
Receives: Biological: pegfilgrastim; Biological: rituximab; Other: flow cytometry; Procedure: biopsy; Other: immunohistochemistry staining method; Genetic: western blotting

What is being measured

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

  1. Number of Participants With Adverse Events

    Frequency of Adverse Events, Graded According to NCI CTCAE v3.0. Grade 1: Mild AE; Grade 2: Moderate AE; Grade 3: Severe AE; Grade 4: Life-threatening or disabling AE; Grade 5: Death related to AE

    Measured: Up to 90 days after the last dose of study drugs

Secondary outcomes (6)

  1. Overall Response Rate

    Overall Response is defined as Complete Response: During observation, no disease is apparent, including measurable and non-measurable disease, and no evidence of disease is observed for at least 28 days, as confirmed by a second assessment following the original observation of no disease; and Partial Response: A 50% or greater decrease from baseline in the sum of the products of the longest perpendicular diameters of all the measured lesions is noted for at least 28 days as confirmed by a second assessment following the observation of the 50% or greater decrease, and no appearance of new lesions is noted.

    Measured: Up to 43 weeks

  2. Percent Change in Functional and Phenotypic Characteristics of Host Neutrophils From Baseline

    Mean percent change in CD11b level from baseline at each visit

    Measured: Baseline and weeks 1, 3, 5, 7, 15, 23, 31, and 39

  3. Percent Change in CD20 Antigen Expression and Density of Expression

    Percent change in CD20 antigen expression and density of expression

    Measured: At 4 years

  4. Percent Change in Serum Levels of Tumor Necrosis Factor (TNF) From Baseline

    Mean percent change in TNF level from baseline at each visit.

    Measured: Baseline and weeks 1, 3, 5, 7, 15, 23, 31, and 39

  5. Percent Change in Serum Levels of Interferon Alpha (INF) From Baseline

    Mean percent change in INF level from baseline.

    Measured: Baseline and weeks 1, 3, 5, 7, 15, 23, 31, and 39

  6. Percent Change in Serum Levels of Free Radical Levels (MFI) From Baseline

    Mean percent change in MFI level from baseline.

    Measured: Baseline and weeks 1, 3, 5, 7, 15, 23, 31, and 39

Timeline

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

  1. First posted10 Sep 2012 (estimated)
  2. Study start17 Apr 2007
  3. Primary completion22 Nov 2013
  4. Study completion22 Dec 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
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01682044
Sponsor's protocol ID
I 83106
Other IDs
NCI-2011-00134
Status last verified
Sep 2017
First submitted
5 Sep 2012
Last updated
9 Oct 2017
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing pegfilgrastim, rituximab and flow cytometry in people with Contiguous Stage II Grade 1 Follicular Lymphoma and Contiguous Stage II Grade 2 Follicular Lymphoma, run by Roswell Park 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 15 inclusion and 15 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 9 Oct 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 9 Oct 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?

Number of Participants With Adverse Events (time frame: Up to 90 days after the last dose of study drugs). 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 NCT01682044.

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 9 Oct 2017.

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