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LymphomaPhase 2NCT00062114

Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab 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 Alliance for Clinical Trials in Oncology at 94 sites in United States.

Completed

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

Official record
Search all trials

Trial summary

RATIONALE: Monoclonal antibodies such as yttrium Y 90 ibritumomab tiuxetan and rituximab can locate cancer cells and either kill them or deliver radioactive cancer-killing substances to them without harming normal cells. 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 yttrium Y 90 ibritumomab tiuxetan
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
94 sitesUnited States
Study dates
Apr 2004to Apr 2007
Phase
Phase 2
Are there results?
None posted in the registry

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

DISEASE CHARACTERISTICS:

  • Histologically confirmed transformed CD20+ B-cell non-Hodgkin's lymphoma (NHL)
  • Transformation defined as:
  • Progression to a more aggressive diffuse lymphoma, excluding conversion to a more aggressive grade of follicular lymphoma (e.g., WHO/REAL follicular center, large, grade III NHL)
  • Initial large cell follicular lymphoma must progress to a diffuse large cell lymphoma
  • De novo transformed NHL ineligible
  • Requiring treatment as determined by any of the following characteristics:
  • An increase in overall tumor size
  • Presence of B symptoms
  • Presence of masses that are causing ongoing clinical symptomatology
  • Must have less than 25% bone marrow involvement with lymphoma
  • Must have received and either relapsed or failed to respond to prior therapy for initial low grade or follicular NHL
  • Must have bidimensionally measurable disease defined as:
  • Greater than 2 cm OR 1.5 cm if 0.5 cm slices are used during spiral CT scan
  • Nonmeasurable disease includes any of the following:
  • Bone lesions
  • Leptomeningeal disease
  • Ascites
  • Pleural or pericardial effusion
  • Inflammatory breast disease
  • Lymphangitis cutis/pulmonis
  • Abdominal masses that are not confirmed and followed by imaging techniques
  • Cystic lesions
  • Lesions that are situated in a previously irradiated area
  • No expected impairment in bone marrrow reserve meeting any of the following criteria:
  • Platelet count less than 150,000/mm^3
  • Hypocellular bone marrow (less than 15% cellularity)
  • Marked reduction in bone marrow precursors of one or more cell lines (e.g., granulocytic, megakaryocytic, or erythroid)
  • History of failed stem cell collection
  • Patients with peritoneal invasion and/or ascites with positive cytology for lymphoma OR pleural invasion and/or effusion with positive cytology for lymphoma are eligible only if their effusion or ascites can be tapped dry
  • No significant remaining malignant effusion or ascites at the time of study drug administration
  • No known meningeal lymphoma or known parenchymal CNS 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

  • 18 and over

Performance status

  • 0-2

Life expectancy

  • Not specified

Hematopoietic

  • See Disease Characteristics
  • Absolute neutrophil count at least 1,500/mm^3
  • Lymphocyte count no greater than 5,000/mm^3
  • Platelet count at least 150,000/mm^3

Hepatic

  • Bilirubin no greater than 2.0 mg/dL

Renal

  • Creatinine no greater than 2.0 mg/dL

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 1 year after study treatment
  • HIV negative
  • No other malignancy except nonmelanoma skin cancer unless patient has completed therapy and is considered to be at less than 30% risk of relapse
  • No human anti-mouse antibody (HAMA) reactivity (patients with prior exposure to murine antibodies)

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • See Radiotherapy
  • At least 3 weeks since prior anticancer immunotherapy (6 weeks for rituximab) and recovered
  • More than 2 weeks since prior filgrastim (G-CSF) or sargramostim (GM-CSF)
  • No prior myeloablative therapy with bone marrow transplantation or peripheral blood stem cell rescue

Chemotherapy

  • See Biologic therapy
  • At least 3 weeks since prior anticancer chemotherapy (6 weeks for nitrosourea or mitomycin) and recovered

Endocrine therapy

  • No concurrent systemic corticosteroids with either of the following dose schedules:
  • No greater than 50 mg of prednisone as a single dose (or equivalent)
  • No greater than 50 mg of prednisone per dose (or equivalent) for more than 6 doses

Radiotherapy

  • See Disease Characteristics
  • At least 3 weeks since prior anticancer radiotherapy and recovered
  • No prior radioimmunotherapy, including yttrium Y 90 ibritumomab tiuxetan
  • No prior external beam radiotherapy to more than 25% of active bone marrow (involved field or regional)

Surgery

  • At least 3 weeks since prior anticancer surgery and recovered
  • More than 4 weeks since prior major surgery (other than diagnostic surgery)

Other

  • At least 3 weeks since other prior anticancer therapy and recovered

Trial locations and contacts

94 sites in 1 country.

94 sites in 1 country

United States94 sites

  • American Fork Hospital

    American Fork, Utah, 84003

  • AnMed Cancer Center

    Anderson, South Carolina, 29621

  • Rush-Copley Cancer Care Center

    Aurora, Illinois, 60507

  • St. Francis Hospital and Health Centers - Beech Grove Campus

    Beech Grove, Indiana, 46107

  • Mountainview Medical

    Berlin Corners, Vermont, 05602

  • St. Luke's Cancer Network at St. Luke's Hospital

    Bethlehem, Pennsylvania, 18015

  • CCOP - Montana Cancer Consortium

    Billings, Montana, 59101

  • Hematology-Oncology Centers of the Northern Rockies - Billings

    Billings, Montana, 59101

  • Northern Rockies Radiation Oncology Center

    Billings, Montana, 59101

  • St. Vincent Healthcare Cancer Care Services

    Billings, Montana, 59101

  • Billings Clinic Cancer Center

    Billings, Montana, 59107-5100

  • Billings Clinic - Downtown

    Billings, Montana, 59107-7000

  • Dana-Farber/Brigham and Women's Cancer Center

    Boston, Massachusetts, 02115

  • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Cancer Research Center at Boston Medical Center

    Boston, Massachusetts, 02118

  • Bozeman Deaconess Cancer Center

    Bozeman, Montana, 59715

  • Providence Saint Joseph Medical Center - Burbank

    Burbank, California, 91505

  • Fletcher Allen Health Care - University Health Center Campus

    Burlington, Vermont, 05401

  • St. James Healthcare Cancer Care

    Butte, Montana, 59701

  • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

    Chapel Hill, North Carolina, 27599-7295

  • University of Illinois Cancer Center

    Chicago, Illinois, 60612-7243

  • University of Chicago Cancer Research Center

    Chicago, Illinois, 60637-1470

  • Case Comprehensive Cancer Center

    Cleveland, Ohio, 44106

  • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University

    Columbus, Ohio, 43210-1240

  • Grandview Hospital

    Dayton, Ohio, 45405

  • Good Samaritan Hospital

    Dayton, Ohio, 45406

  • David L. Rike Cancer Center at Miami Valley Hospital

    Dayton, Ohio, 45409

  • Samaritan North Cancer Care Center

    Dayton, Ohio, 45415

  • Veterans Affairs Medical Center - Dayton

    Dayton, Ohio, 45428

  • CCOP - Dayton

    Dayton, Ohio, 45429

  • Union Hospital Cancer Program at Union Hospital

    Elkton MD, Maryland, 21921

  • Blanchard Valley Medical Associates

    Findlay, Ohio, 45840

  • Charles R. Wood Cancer Center at Glens Falls Hospital

    Glens Falls, New York, 12801

  • Wayne Memorial Hospital, Incorporated

    Goldsboro, North Carolina, 27534

  • Wayne Radiation Oncology

    Goldsboro, North Carolina, 27534

  • Great Falls Clinic - Main Facility

    Great Falls, Montana, 59405

  • Study site

    Great Falls, Montana, 59405

  • St. Peter's Hospital

    Helena, Montana, 59601

  • Joliet Oncology-Hematology Associates, Limited - West

    Joliet, Illinois, 60435

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007-3731

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

  • Borgess Medical Center

    Kalamazooaa, Michigan, 49001

  • Glacier Oncology, PLLC

    Kalispell, Montana, 59901

  • Kalispell Medical Oncology at KRMC

    Kalispell, Montana, 59901

  • Kalispell Regional Medical Center

    Kalispell, Montana, 59901

  • Kingsbury Center for Cancer Care at Cheshire Medical Center

    Keene, New Hampshire, 03431

  • Charles F. Kettering Memorial Hospital

    Kettering, Ohio, 45429

  • Moores UCSD Cancer Center

    La Jolla, California, 92093-0658

  • Norris Cotton Cancer Center at Dartmouth - Hitchcock Medical Center

    Lebanon, New Hampshire, 03756-0002

  • Beebe Medical Center

    Lewes, Delaware, 19958

  • Central Maine Comprehensive Cancer Center at Central Maine Medical Center

    Lewiston, Maine, 04240

  • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • Logan Regional Hospital

    Logan, Utah, 84321

  • Saint Anthony Memorial Health Centers

    Michigan City, Indiana, 46360

  • Middletown Regional Hospital

    Middletown, Ohio, 45044

  • Community Medical Center

    Missoula, Montana, 59801

  • Guardian Oncology and Center for Wellness

    Missoula, Montana, 59804

  • Montana Cancer Specialists at Montana Cancer Center

    Missoula, Montana, 59807-7877

  • Montana Cancer Center at St. Patrick Hospital and Health Sciences Center

    Missoula, Montana, 59807

  • Cottonwood Hospital Medical Center

    Murray, Utah, 84107

  • New York Weill Cornell Cancer Center at Cornell University

    New York, New York, 10021

  • CCOP - Christiana Care Health Services

    Newark, Delaware, 19713

  • McKay-Dee Hospital Center

    Ogden, Utah, 84403

  • Methodist Estabrook Cancer Center

    Omaha, Nebraska, 68114

  • Utah Valley Regional Medical Center - Provo

    Provo, Utah, 84604

  • Reid Hospital & Health Care Services, Incorporated

    Richmond, Indiana, 47374

  • Virginia Commonwealth University Massey Cancer Center

    Richmond, Virginia, 23298-0037

  • Frisbie Memorial Hospital

    Rochester, New Hampshire, 03867

  • Rutherford Hospital

    Rutherfordton, North Carolina, 28139

  • Tammy Walker Cancer Center at Salina Regional Health Center

    Salina, Kansas, 67401

  • Utah Cancer Specialists at UCS Cancer Center

    Salt Lake City, Utah, 84106

  • Latter Day Saints Hospital

    Salt Lake City, Utah, 84143

  • Kaiser Permanente Medical Office -Vandever Medical Office

    San Diego, California, 92120

  • Welch Cancer Center at Sheridan Memorial Hospital

    Sheridan, Wyoming, 82801

  • Avera Cancer Institute

    Sioux Falls, South Dakota, 57105

  • Sioux Valley Hospital and University of South Dakota Medical Center

    Sioux Falls, South Dakota, 57117-5039

  • CCOP - Upstate Carolina

    Spartanburg, South Carolina, 29303

  • Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

    Spartanburg, South Carolina, 29303

  • CCOP - Cancer Research for the Ozarks

    Springfield, Missouri, 65802

  • St. John's Regional Health Center

    Springfield, Missouri, 65804

  • Hulston Cancer Center at Cox Medical Center South

    Springfield, Missouri, 65807

  • Dixie Regional Medical Center - East Campus

    St. George, Utah, 84770

  • Stony Brook University Cancer Center

    Stony Brook, New York, 11794-8174

  • CCOP - Scott and White Hospital

    Temple, Texas, 76508

  • Our Lady of Mercy Medical Center Comprehensive Cancer Center

    The Bronx, New York, 10466

  • Cotton-O'Neil Cancer Center

    Topeka, Kansas, 66604

  • St. Francis Comprehensive Cancer Center

    Topeka, Kansas, 66606

  • UVMC Cancer Care Center at Upper Valley Medical Center

    Troy, Ohio, 45373-1300

  • Carle Cancer Center at Carle Foundation Hospital

    Urbana, Illinois, 61801

  • CCOP - Carle Cancer Center

    Urbana, Illinois, 61801

  • Cancer Institute of New Jersey at Cooper - Voorhees

    Voorhees Township, New Jersey, 08043

  • Wilson Medical Center

    Wilson, North Carolina, 27893-3428

  • Wake Forest University Comprehensive Cancer Center

    Winston-Salem, North Carolina, 27157-1096

  • Ruth G. McMillan Cancer Center at Greene Memorial Hospital

    Xenia, Ohio, 45385

Other trials in United States

About this study

Official title: A Phase II Study To Evaluate The Safety And Efficacy Of Zevalin (IND # BB IND 4850) Therapeutic Regimen In Patients With Transformed CD20 + B-Cell Non-Hodgkin's Lymphoma

RATIONALE: Monoclonal antibodies such as yttrium Y 90 ibritumomab tiuxetan and rituximab can locate cancer cells and either kill them or deliver radioactive cancer-killing substances to them without harming normal cells.

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

Read the detailed description

OBJECTIVES:

  • Determine the efficacy of yttrium Y 90 ibritumomab tiuxetan and rituximab, in terms of overall response rate (complete, unconfirmed complete, and partial) and duration of response, in patients with transformed CD20+ B-cell non-Hodgkin's lymphoma.
  • Determine the safety of this regimen in these patients.
  • Determine the event-free survival and time to treatment progression in patients treated with this regimen.
  • Determine the immunogenicity of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive rituximab IV followed within 4 hours by indium In 111 ibritumomab tiuxetan IV (for imaging) over 10 minutes on day 1. Patients undergo 1 (or 2 if needed) imaging scan between days 2-5. In the absence of altered biodistribution, patients receive rituximab IV followed within 4 hours by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 8.

Patients are followed monthly for 3 months, every 3 months for 2 years, and then every 6 months for 2 years.

Conditions
Lymphoma
Being tested
rituximab, yttrium Y 90 ibritumomab tiuxetan
Keywords
recurrent adult diffuse large cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult immunoblastic large cell lymphoma
Medical subject headings
Lymphoma, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Non-Hodgkin, Lymphoma, Large-Cell, Immunoblastic

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 NCT00062114
Study groupRoleWhat they receive
rituximab + yttrium Y 90 ibritumomab tiuxetanExperimentalPatients receive rituximab IV followed within 4 hours by yttrium Y 90 ibritumomab tiuxetan IV (for imaging) over 10 minutes on day 1. Patients undergo 1 (or 2 if needed) imaging scan between days 2-5. In the absence of altered biodistribution, patients receive rituximab IV followed within 4 hours by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 8. Patients are followed monthly for 3 months, every 3 months for 2 years, and then every 6 months for 2 years.
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. Overall response rate

    Measured: Up to 4 years

  2. Duration of response

    Measured: Up to 4 years

Secondary outcomes (4)

  1. Complete response (CR), unconfirmed CR, and partial response

    Measured: Up to 4 years

  2. Event-free survival

    Measured: Up to 4 years

  3. Time to progression

    Measured: Up to 4 years

  4. Time to next lymphoma treatment

    Measured: Up to 4 years

Timeline

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

  1. First posted6 Jun 2003 (estimated)
  2. Study startApr 2004
  3. Primary completionApr 2007
  4. Study completionApr 2007

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
84 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00062114
Sponsor's protocol ID
CALGB-50201
Other IDs
CALGB-50201, CDR0000304498
Status last verified
Jul 2016
First submitted
5 Jun 2003
Last updated
6 Jul 2016
Results posted
No
Data monitoring committee
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 Alliance for Clinical Trials in Oncology at 94 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: finished, as of the sponsor's last update on 6 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 94 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Overall response rate (time frame: Up to 4 years). 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?

On the ClinicalTrials.gov record for NCT00062114.

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 6 Jul 2016.

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