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Diffuse Large B-cell LymphomaPhase 3NCT01510184

Study of Zevalin Versus Observation in Participants at Least 60 Years Old With Newly Diagnosed Diffuse Large B-cell Lymphoma in Positron Emission Tomography (PET)-Negative Complete Remission After Rituximab-Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) or R-CHOP-like Therapy

A Phase 3 study testing Zevalin, Y-90-Zevalin and Rituximab in people with Diffuse Large B-cell Lymphoma and Follicle Center Lymphoma, run by Spectrum Pharmaceuticals, Inc at 93 sites in 13 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

The purpose of this study is to evaluate the efficacy and safety of Zevalin compared with observation alone in participants who are in PET-negative complete remission after first-line R-CHOP or R-CHOP like therapy. Read more about this study

Who is it for?
Ages 60 years and older
What is being tested?
Zevalin, Y-90-Zevalin and Rituximab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
79 participants
Where
93 sitesin 13 countries
Study dates
19 Apr 2012to 23 Oct 2014
Phase
Phase 3
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 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participant was 60-years of age or older at time of randomization
  • Histologically confirmed Ann Arbor stage II, III, or IV diffuse large B-cell lymphoma (DLBCL); or follicular lymphoma (FCL) Grade 3B according to the Revised European American lymphoma (REAL)/ World health organization (WHO) classification (from initial diagnosis made prior to starting R-CHOP therapy. Results from a pre R-CHOP marrow shall be available for review.
  • Local pathology review confirming the DLBCL diagnosis and cluster of differentiation 20 (CD20) positivity, and no evidence of DLBCL in bone marrow upon confirmation of complete remission (CR).
  • A paraffin block or original slides available for confirmatory pathology review. Participants may be randomized based on the local pathology result.
  • Age-adjusted international prognostic index (IPI) of 1, 2, or 3. The age-adjusted IPI was defined by one point for Lactate dehydrogenase (LDH) > upper limit of normal (ULN); Stage III or IV; and Karnofsky performance status <80% or WHO/ eastern cooperative operations group (ECOG) performance status >1.
  • First-line treatment of DLBCL must have been 6 cycles of standard R-CHOP21, R-CHOP14 or dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (DA-EPOCH-R) chemotherapy. Participants who received pre-phase therapy for the purpose of improving performance status prior to initiating R-CHOP are eligible.
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  • Complete remission (CR) according to the International Workshop Response Criteria for non-Hodgkin's lymphoma (NHL) described by Cheson et al after first-line treatment. Computerized tomography (CT) scans of chest, abdomen, pelvis, and neck (if applicable) must have been performed within 6 weeks after the last dose of the last course of chemotherapy. Applicability of the neck CT means that the participant had involvement of the neck region by palpation / physical examination at first diagnosis.
  • A negative Fluorine-18-deoxyglucose positron emission tomography (FDG-PET) scan confirming complete response, with negative defined as a score of 1-3 on the Deauville 5-point scale used to quantify radionucleotide density in PET scans as determined locally (Morschhauser 200735).
  • Bone marrow cellularity greater than 15%, no evidence of myelodysplasia morphologically and no evidence of involvement with lymphoma either at the pre R-CHOP marrow or on repeat assessment pre-Zevalin. After completing R-chemotherapy, a repeat marrow is required for participant randomized to the Zevalin arm only.
  • A world health organization/eastern cooperative oncology group (WHO/ECOG) performance status of 0, 1 or 2.
  • Adequate hematopoietic functions: Absolute neutrophil count (ANC) ≥ 1.0 x 10^9/ liter (L), Hemoglobin (Hgb) ≥ 9 g/dL, Platelets ≥ 100 x 10^9/L.
  • Life expectancy of 6 months or longer.
  • Written informed consent obtained according to local guidelines.

Who cannot join

  • Presence of any other malignancy or history of prior malignancy within 5 years of study entry. Within 5 years, participants treated for Stage I or II cancers are eligible provided they have a life expectancy of > 5 years. The 5-year exclusion rule does not apply to-non melanoma skin tumors and in situ cervical cancer.
  • Prior radioimmunotherapy, including radiation therapy for Non-Hodgkin's lymphoma) NHL, or any other NHL therapy.
  • Presence of primary gastric, central nervous system (CNS), or testicular lymphoma at first diagnosis.
  • Histological transformation of low-grade NHL.
  • Active hepatitis B or C.
  • Known history of human immunodeficiency virus (HIV) infection.
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  • Abnormal liver function: total bilirubin > 2 × ULN unless secondary to Gilbert disease.
  • Abnormal renal function: serum creatinine > 2.0 × ULN.
  • Non-recovery from the toxic effects of chemotherapy to < grade 2, or interfering with Zevalin treatment.
  • Known hypersensitivity to murine or chimeric antibodies or proteins.
  • Granulocyte-colony stimulating factor (G-CSF) or Granulocyte macrophage-colony stimulating factor (GM-CSF) therapy within 4 weeks prior to Zevalin or observation.
  • Concurrent severe and/or medically uncontrolled disease (e.g. uncontrolled diabetes, congestive heart failure, myocardial infarction within 6 months of study, unstable and uncontrolled hypertension, chronic renal disease, or active uncontrolled infection) which could compromise participation in the study.
  • Treatment with investigational drugs less than 4 weeks prior to Zevalin or observation.
  • Major surgery less than 4 weeks prior to Zevalin or start of observation.
  • Concurrent systemic corticosteroid use for any reason except as premedication in case of known or suspected allergies to contrast media or as premedication for potential side effects of rituximab treatment. Participants on a chronic dose of prednisone for a medical condition (e.g. Asthma or autoimmune disease) less than or equal to 20 milligram (mg) daily, stable for 4 weeks, are permissible.
  • Unwillingness or inability to comply with the protocol.

Trial locations and contacts

93 sites in 13 countries.

93 sites in 13 countries

United States28 sites

  • Piedmont Hospital Cancer Center

    Atlanta, Georgia, 30318

  • Sutter East Bay Hospitals

    Berkeley, California, 94704

  • St. Luke's Mountain States Tumor Institute (MSTI)

    Boise, Idaho, 83712

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Cancer Treatment Services Arizona

    Casa Grande, Arizona, 85122

  • Associates In Oncology and Hematology

    Chattanooga, Tennessee, 37421

  • Northwestern University Feinberg School of Medicine

    Chicago, Illinois, 60611

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Halifax Health Medical Center

    Daytona Beach, Florida, 32114

  • Decatur Memorial Hospital Cancer Care Specialists of Central Illinois

    Decatur, Illinois, 62526

  • City of Hope

    Duarte, California, 91010

  • Adams Cancer center

    Gettysburg, Pennsylvania, 17325

  • Saint Francis Hospital

    Greenville, South Carolina, 29601

  • St. John Hospital and Medical Center

    Grosse Pointe Woods, Michigan, 48236

  • Hackensack UMC / John Theurer Cancer Center

    Hackensack, New Jersey, 07601

  • Comprehensive Cancer Centers of Nevada

    Henderson, Nevada, 89044

  • The University of Texas M.D. Anderson Cancer Center

    Houston, Texas, 77030

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • Norton Cancer Institute, Suburban

    Louisville, Kentucky, 40207

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065

  • Illinois Cancer Specialists

    Niles, Illinois, 60714

  • Oncology Research-Park Nicollet Institute

    Saint Louis Park, Minnesota, 55426

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98109

  • Avera Hematology and Transplant

    Sioux Falls, South Dakota, 57105

  • Saint Louis University

    St Louis, Missouri, 63110

  • H. Lee Moffitt Cancer Center

    Tampa, Florida, 33612

  • York Cancer Center / Cancer Care Associates of York

    York, Pennsylvania, 17403

  • Midwestern Regional Medical Center

    Zion, Illinois, 60099

Other trials in United States

France23 sites

  • CHU Amiens, Hôpital Sud

    Amiens, 80054

  • CH Avignon

    Avignon, 84902

  • CH de la Côte Basque, Service d'Hématologie

    Bayonne, 64109

  • Hématologie - CHU Jean Minjoz

    Besançon, 25030

  • Institut Bergonié

    Bordeaux, 33076

  • Hopital MORVAN - CHU Brest

    Brest, 29609

  • Centre François Baclesse, Comite Hématologie

    Caen, 14076

  • Hôpital Henri MONDOR

    Créteil, 94010

  • CHU A Michallon

    Grenoble, Cedex 9, 38043

  • CHD Vendée

    La Roche-sur-Yon, 85925

  • CHRU Lille- Hospital Claude Huriez

    Lille, 59037

  • CHU Dupuytren

    Limoges, Cedex, 87042

  • Institut Paoli-Calmettes

    Marseille, 13273

  • CHR Metz-Thionville

    Metz, 57085

  • CH de Mulhouse - Hôpital Emile Muller

    Mulhouse, 68100

  • Centre Antoine Lacassagne

    Nice, 06189

  • CHR Orléans

    Orléans, 45100

  • Institut Curie

    Paris, 75005

  • Centre Hospitalier Saint Jean

    Perpignan, 66000

  • Hôpital Haut-Levêque Centre F.Magendie

    Pessac, 33600

  • Centre Hospitalier René Dubos,

    Pontoise, 95303

  • Service d'Hématologie Centre Henri Becquerel

    Rouen, 76038

  • CHU de Brabios

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Netherlands9 sites

  • Meander Medisch Centrum

    Amersfoort, 3813 TZ

  • VU Medisch Centrum

    Amsterdam, 1081

  • University Medical Centre Groningen (UMCG)

    Groningen, 9713GZ

  • Spaarne Ziekenhuis, Internal Medicine/Ocology

    Hoofddorp, 2134TM

  • Medisch Centrum Leeuwarden

    Leeuwarden, 8934 AD

  • St. Antonius Hospital

    Nieuwegein, 3435 CM

  • University Medical Center Radboud Nijmegen

    Nijmegen, 6525

  • Erasmus Medisch Centrum

    Rotterdam, NL-3015

  • Haga Ziekenhuis

    The Hague, 2545 CH

Other trials in Netherlands

Israel6 sites

  • Soroka Medical Centre

    Beersheba, 84101

  • Rambam Health Care Campus

    Haifa

  • Hadassah Medical Organization

    Jerusalem, 91120

  • Shaare Zedek Medical Center

    Jerusalem, 93722

  • Tel Aviv Sourasky Medical Centre

    Tel Aviv, 64239

  • Chaim Sheba Medical Center

    Tel HaShomer, 52621

Other trials in Israel

Australia5 sites

  • Royal Adelaide Hospital

    Adelaide

  • Barwon Health

    Geelong, 3220

  • Royal Hobart Hospital

    Hobart, Tasmania, 7001

  • Western Hospital

    Melbourne

  • Royal Melbourne

    Parkville, Victoria, 3052

Other trials in Australia

Italy5 sites

  • Policlinico S Orsola Malpighi, Istituto di Ematologia ''L.e A. Seragnoli''

    Bologna, 40138

  • New Ematologia dell'Ospedale "Spedali Civili" di Brescia

    Brescia, 25123

  • Divisione di Ematoncologia

    Milan, 20141

  • Azienda Ospedaliera Sant'Andrea

    Roma, 00189

  • Azienda Ospedaliera San. Giovanni Battista di Torino, Dipartimento di Oncologia U.O.A Ematologia, Le Molinette,

    Torino, 10126

Other trials in Italy

United Kingdom5 sites

  • Department of Haematology Bristol Royal Infirmary

    Bristol, BS2 8HW

  • Poole General Hospital

    Dorset, BH15

  • Beatson Cancer Centre

    Glasgow, G12 0YN

  • King's College Hospital

    London, SE5 9RS

  • The Christie NHS Foundation Trust, The Christie Hospital,

    Manchester, M20 4BX

Other trials in United Kingdom

Canada3 sites

  • CSSS Champlain Charles LeMoyne

    Greenfield Park, Quebec, J4V2H1

  • Thunder Bay Regional Health Sciences Centre-Regional Cancer Care

    Thunder Bay, Ontario, P7B 6V4

  • Sunnybrook Research Institute

    Toronto, Ontario

Other trials in Canada

Spain3 sites

  • Clínica Universidad de Navarra (CUN)

    Pamplona

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009

  • Miguel Servet University Hospital

    Zaragoza

Other trials in Spain

Belgium2 sites

  • Nuclear Medicine Physician, Jules Bordet Institute

    Brussels, 1000

  • University Hospital Gasthuisberg

    Leuven, 3000

Other trials in Belgium

Ireland2 sites

  • St James 's Hospital

    Dublin, 8

  • University Hospital Galway

    Galway

Other trials in Ireland

Austria1 site

  • Medizinische Universität Wien -AKH Wien

    Vienna, A-1090

Other trials in Austria

Puerto Rico1 site

  • Auxilio Mutuo Cancer Center

    San Juan, 00918

Other trials in Puerto Rico

About this study

Official title: A Phase 3, Open-label, Multicenter, Randomized Study of Sequential Zevalin (Ibritumomab Tiuxetan) Versus Observation in Patients at Least 60 Years of Age With Newly Diagnosed Diffuse Large B-cell Lymphoma in PET-negative Complete Remission After R-CHOP or R-CHOP-like Therapy

The purpose of this study is to evaluate the efficacy and safety of Zevalin compared with observation alone in participants who are in PET-negative complete remission after first-line R-CHOP or R-CHOP like therapy.

Being tested
Zevalin, Y-90-Zevalin, Rituximab, In-111 Zevalin
Medical subject headings
Lymphoma, Large B-Cell, Diffuse, Lymphoma, Follicular

What participants receive

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

  • ZevalinDrug

    Also called Ibritumomab Tiuxetan

    Zevalin administered intravenous infusion.

  • Y-90-ZevalinDrug

    Y-90-Zevalin administered by intravenous infusion.

  • RituximabDrug

    Rituximab administered by intravenous infusion.

  • In-111 ZevalinDrug

    In-111-Zevalin administered by intravenously.

Study groups in NCT01510184
Study groupRoleWhat they receive
ZevalinExperimentalParticipants received rituximab 250 milligram per meter square (mg/m^2) by intravenous infusion on Day 1. If required by the governing regulatory agency, rituximab was to be followed 4 hours later by In-111-Zevalin 5.0 millicurie (mCi) on Day 1. And on Days 7-9: participants received rituximab 250 mg/m^2 by intravenous infusion, followed 4 hours later by Y-90-Zevalin 0.4 millicurie/kilogram (mCi/kg) 10-minute intravenous push (0.3 mCi/kg in participants with a platelet count in 100,000/ microliter [μL] to 149,000/μL).
Receives: Drug: Zevalin; Drug: Y-90-Zevalin; Drug: Rituximab; Drug: In-111 Zevalin
ObservationNo interventionParticipants who were randomized in this arm group did not receive any anti-lymphoma therapy unless they had a relapse of their disease.

What is being measured

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

  1. Overall Survival (OS) for Living Participants

    OS was the time from randomization to death. In living participants, survival time was censored on the last date that participants were known to be alive. OS for living participant was calculated as (end of study date/last visit date - randomization date)+ 1/30.4375. Overall Survival was summarized separately for living participants as only few participants died in this study.

    Measured: From randomization till death or end of study, whichever occurs first (Up to approximately 2.5 years)

  2. Overall Survival for Death

    OS was the time from randomization to death. OS for death calculated as (date of death - randomization date)+ 1/30.4375. Overall Survival was summarized separately for participants who were died as only few participants died in this study.

    Measured: From randomization till death or end of study, whichever occurs first (Up to approximately 2.5 years)

Secondary outcomes (2)

  1. Progression-Free Survival (PFS)

    PFS was defined as the time interval between the date of randomization and the date of relapse or death from any cause.

    Measured: From randomization till death or end of study, whichever occurs first (Up to approximately 2.5 years)

  2. Overall Survival Rate at 24 Months

    The OS rate at 24-month defined as the percentage of all randomized participants who died within 24 months of randomization.

    Measured: 24 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 Jan 2012 (estimated)
  2. Study start19 Apr 2012
  3. Primary completion23 Oct 2014
  4. Study completion23 Oct 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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
79 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01510184
Sponsor's protocol ID
SPI-ZEV-11-301
Status last verified
Nov 2021
First submitted
6 Jan 2012
Last updated
16 Dec 2021
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Zevalin, Y-90-Zevalin and Rituximab in people with Diffuse Large B-cell Lymphoma and Follicle Center Lymphoma, run by Spectrum Pharmaceuticals, Inc at 93 sites in 13 countries.

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 13 inclusion and 16 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 16 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 93 sites in United States, France, Netherlands, Israel, Australia and 8 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 16 Dec 2021). 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?

Overall Survival (OS) for Living Participants (time frame: From randomization till death or end of study, whichever occurs first (Up to approximately 2.5 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 NCT01510184.

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 16 Dec 2021.

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