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LymphomaPhase 2NCT00110149

Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Non-Hodgkin's Lymphoma

A Phase 2 study testing rituximab and yttrium Y 90 ibritumomab tiuxetan in people with Lymphoma, run by Beth Israel Deaconess Medical Center at 3 sites 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

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, such as yttrium Y 90 ibritumomab tiuxetan, find cancer cells and help kill them or carry cancer-killing substances to them without harming normal cells. Read more about this study

Who is it for?
Ages 18 to 120 years
Conditions the study is for
Lymphoma
What is being tested?
rituximab and yttrium Y 90 ibritumomab tiuxetan
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
3 sitesUnited States
Study dates
May 2004to Mar 2015
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 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed indolent non-Hodgkin's lymphoma (NHL), including 1 of the following histologic subtypes:
  • Grade1 or 2 follicular lymphoma
  • Small lymphocytic lymphoma (SLL)
  • Marginal zone B-cell lymphoma
  • CD20-positive disease confirmed by immunohistochemistry or flow cytometry
  • Bidimensionally measurable disease
  • At least 1 lesion measuring ≥ 2.0 cm in a single dimension by CT scan
  • Less than 25% bone marrow involvement with lymphoma by bilateral iliac crest bone marrow aspiration and biopsy within the past 6 weeks
  • No clinically significant impaired bone marrow reserve as evidenced by any of the following:
  • Hypocellular marrow, as evidenced by 1 of the following:
  • ≤ 15% cellularity
  • Marked reduction in bone marrow precursors
  • Platelet count < 100,000/mm^3
  • Absolute neutrophil count < 1,500/mm^3
  • History of failed stem cell collection
  • Prior myeloablative therapy
  • No greater than 5,000/mm^3 circulating tumor cells in peripheral blood
  • Requires antilymphoma therapy, as indicated by any of the following:
  • Systemic symptoms
  • B symptoms
  • Cytopenias
  • Malaise
  • Organ compromise
  • Discomfort
  • Pain
  • Disfigurement
  • Rapidly progressive disease
  • Undue anxiety related to not receiving treatment
  • No transformation to intermediate or high-grade NHL
  • No known brain metastases or CNS involvement by lymphoma NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.

PATIENT CHARACTERISTICS:

Age

  • Over 18

Performance status

  • ECOG 0-2 OR
  • WHO 0-2 OR
  • Karnofsky 70-100%

Life expectancy

  • More than 3 months

Hematopoietic

  • See Disease Characteristics
  • WBC ≥ 3,000/mm^3
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Lymphocyte count < 5,000/mm^3 (for patients with SLL )

Hepatic

  • Bilirubin ≤ 2.0 mg/dL
  • AST and ALT ≤ 2.5 times upper limit of normal

Renal

  • Creatinine ≤ 2.0 mg/dL OR
  • Creatinine clearance > 60 mL/min

Cardiovascular

  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia

Immunologic

  • No anti-murine antibody reactivity (in patients with prior exposure to murine antibodies or proteins)
  • No ongoing or active infection
  • No history of allergic reaction attributed to compounds of similar chemical or biologic composition to yttrium Y 90 ibritumomab tiuxetan

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for at least 1 year after study treatment
  • No other active malignancy except non-melanoma skin cancer
  • No other serious nonmalignant disease that would preclude study participation
  • No psychiatric illness or social situation that would preclude study compliance
  • No other uncontrolled illness

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • More than 4 weeks since prior pegfilgrastim
  • More than 2 weeks since prior filgrastim (G-CSF) or sargramostim (GM-CSF)

Chemotherapy

  • No prior chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • No prior external beam radiotherapy to > 25% of active bone marrow (involved field or regional)

Surgery

  • More than 4 weeks since prior major surgery except diagnostic surgery

Other

  • No prior systemic antilymphoma therapy
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No other concurrent anticancer therapy
  • No other concurrent investigational agents
  • No other concurrent antilymphoma therapy

Trial locations and contacts

3 sites in 1 country.

United States3 sites
  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Vermont Cancer Center at University of Vermont

    Burlington, Vermont, 05401-3498

  • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756-0002

Other trials in United States

About this study

Official title: A Phase II Study of Yttrium-90-Labeled Ibritumomab Tiuxetan (Zevalin) Radioimmunotherapy as First Line Treatment in Indolent Non-Hodgkin's Lymphoma

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, such as yttrium Y 90 ibritumomab tiuxetan, find cancer cells and help kill them or carry cancer-killing substances to them without harming normal cells. Giving rituximab together with yttrium Y 90 ibritumomab tiuxetan may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving rituximab together with yttrium Y 90 ibritumomab tiuxetan works in treating patients with indolent non-Hodgkin's lymphoma.

Read the detailed description

OBJECTIVES:

Primary

  • Determine 12-week overall and complete response rate in patients with indolent non-Hodgkin's lymphoma treated with rituximab and yttrium Y 90 ibritumomab tiuxetan as first-line treatment.

Secondary

  • Determine 1-year event-free survival of patients treated with this regimen.
  • Determine time to progression and time to next antilymphoma therapy in patients treated with this regimen.
  • Determine the molecular response rate in patients treated with this regimen.
  • Determine the hematological and non-hematological toxicity of this regimen in these patients.
  • Assess the quality of life of patients treated with this regimen.

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

Patients receive rituximab IV followed, no more than 4 hours later, by indium In 111 ibritumomab tiuxetan (for imaging) IV over 10 minutes on day 1. If biodistribution is acceptable, patients receive rituximab IV followed, no more than 4 hours later, by a single dose of yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 7, 8, or 9 in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, weeks 6, 10, and 14, every 3 months for 2 years, and then every 6 months for 2 years.

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

PROJECTED ACCRUAL: A total of 18-28 patients will be accrued for this study within 2 years.

Conditions
Lymphoma
Being tested
rituximab, yttrium Y 90 ibritumomab tiuxetan
Keywords
contiguous stage II grade 1 follicular lymphoma, noncontiguous stage II grade 1 follicular lymphoma, stage I grade 1 follicular lymphoma, stage III grade 1 follicular lymphoma, stage IV grade 1 follicular lymphoma, contiguous stage II grade 2 follicular lymphoma, noncontiguous stage II grade 2 follicular lymphoma, stage I grade 2 follicular lymphoma, stage III grade 2 follicular lymphoma, stage IV grade 2 follicular lymphoma, contiguous stage II marginal zone lymphoma, noncontiguous stage II marginal zone lymphoma, splenic marginal zone lymphoma, stage I marginal zone lymphoma, stage III marginal zone lymphoma, stage IV marginal zone lymphoma, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue, nodal marginal zone B-cell lymphoma, contiguous stage II small lymphocytic lymphoma, noncontiguous stage II small lymphocytic lymphoma
Medical subject headings
Lymphoma, Lymphoma, Follicular, Lymphoma, B-Cell, Marginal Zone, Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

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

  • rituximabBiological

  • yttrium Y 90 ibritumomab tiuxetanRadiation

Study groups in NCT00110149
Study groupRoleWhat they receive
Rituximab and Yttrium Y 90 Ibritumomab TiuxetanExperimentalRituximab and Yttrium Y 90 Ibritumomab Tiuxetan
Receives: Biological: rituximab; Radiation: yttrium Y 90 ibritumomab tiuxetan

What is being measured

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

  1. Response Rate (Complete Response, Unconfirmed Complete Response, and Partial Response) at 12 Weeks

    INTERNATIONAL WORKSHOP RESPONSE CRITERIA FOR NON HODGKIN'S LYMPHOMA

    Cheson BD, Horning SJ, Coiffier B, Shipp MA, Fisher RI, Connors JM, et al. Report of an international workshop to standardize response criteria for non Hodgkin's lymphoma. J Clin Oncol 1999;17(4):1244-53.

    Measured: 14 weeks

  2. EFS

    Event = Death, second malignancy , disease progression.

    Measured: 1 year

Timeline

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

  1. First posted4 May 2005 (estimated)
  2. Study startMay 2004
  3. Primary completionMay 2012
  4. Study completionMar 2015

Why it stopped: Company withdrew drug supply

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
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00110149
Sponsor's protocol ID
2004P000044
Other IDs
CDR0000409723, NCI-2011-02445
Status last verified
Oct 2017
First submitted
3 May 2005
Last updated
21 Nov 2017
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing rituximab and yttrium Y 90 ibritumomab tiuxetan in people with Lymphoma, run by Beth Israel Deaconess Medical Center at 3 sites 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?

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 21 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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 21 Nov 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?

Response Rate (Complete Response, Unconfirmed Complete Response, and Partial Response) at 12 Weeks (time frame: 14 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 21 Nov 2017.

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