Phase
Condition
Lymphoma, B-cell
Follicular Lymphoma
Hematologic Cancer
Treatment
N/AClinical Study ID
Ages > 60 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 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 EuropeanAmerican lymphoma (REAL)/ World health organization (WHO) classification (from initialdiagnosis made prior to starting R-CHOP therapy. Results from a pre R-CHOP marrowshall 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 ofcomplete 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 IPIwas defined by one point for Lactate dehydrogenase (LDH) > upper limit of normal (ULN); Stage III or IV; and Karnofsky performance status <80% or WHO/ easterncooperative operations group (ECOG) performance status >1.
- First-line treatment of DLBCL must have been 6 cycles of standard R-CHOP21, R-CHOP14or dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin,and rituximab (DA-EPOCH-R) chemotherapy. Participants who received pre-phase therapyfor the purpose of improving performance status prior to initiating R-CHOP areeligible.
- Complete remission (CR) according to the International Workshop Response Criteria fornon-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 ofchemotherapy. Applicability of the neck CT means that the participant had involvementof the neck region by palpation / physical examination at first diagnosis.
- A negative Fluorine-18-deoxyglucose positron emission tomography (FDG-PET) scanconfirming 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 determinedlocally (Morschhauser 200735).
- Bone marrow cellularity greater than 15%, no evidence of myelodysplasiamorphologically and no evidence of involvement with lymphoma either at the pre R-CHOPmarrow or on repeat assessment pre-Zevalin. After completing R-chemotherapy, a repeatmarrow is required for participant randomized to the Zevalin arm only.
- A world health organization/eastern cooperative oncology group (WHO/ECOG) performancestatus 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.
Exclusion
Exclusion Criteria:
- Presence of any other malignancy or history of prior malignancy within 5 years ofstudy entry. Within 5 years, participants treated for Stage I or II cancers areeligible provided they have a life expectancy of > 5 years. The 5-year exclusion ruledoes 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 atfirst diagnosis.
- Histological transformation of low-grade NHL.
- Active hepatitis B or C.
- Known history of human immunodeficiency virus (HIV) infection.
- Abnormal liver function: total bilirubin > 2 × ULN unless secondary to Gilbertdisease.
- Abnormal renal function: serum creatinine > 2.0 × ULN.
- Non-recovery from the toxic effects of chemotherapy to < grade 2, or interfering withZevalin treatment.
- Known hypersensitivity to murine or chimeric antibodies or proteins.
- Granulocyte-colony stimulating factor (G-CSF) or Granulocyte macrophage-colonystimulating 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 anduncontrolled 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 orobservation.
- Major surgery less than 4 weeks prior to Zevalin or start of observation.
- Concurrent systemic corticosteroid use for any reason except as premedication in caseof known or suspected allergies to contrast media or as premedication for potentialside effects of rituximab treatment. Participants on a chronic dose of prednisone fora medical condition (e.g. Asthma or autoimmune disease) less than or equal to 20milligram (mg) daily, stable for 4 weeks, are permissible.
- Unwillingness or inability to comply with the protocol.
Study Design
Connect with a study center
Royal Hobart Hospital
Hobart, Tasmania 7001
AustraliaSite Not Available
Royal Melbourne
Parkville, Victoria 3052
AustraliaSite Not Available
Royal Adelaide Hospital
Adelaide,
AustraliaSite Not Available
Barwon Health
Geelong, 3220
AustraliaSite Not Available
Western Hospital
Melbourne,
AustraliaSite Not Available
Medizinische Universität Wien -AKH Wien
Vienna, A-1090
AustriaSite Not Available
Nuclear Medicine Physician, Jules Bordet Institute
Bruxelles, 1000
BelgiumSite Not Available
University Hospital Gasthuisberg
Leuven, 3000
BelgiumSite Not Available
Thunder Bay Regional Health Sciences Centre-Regional Cancer Care
Thunder Bay, Ontario P7B 6V4
CanadaSite Not Available
Sunnybrook Research Institute
Toronto, Ontario
CanadaSite Not Available
CSSS Champlain Charles LeMoyne
Greenfield Park, Quebec J4V2H1
CanadaSite Not Available
CHU Dupuytren
Limoges, Cedex 87042
FranceSite Not Available
CHU A Michallon
Grenoble, Cedex 9 38043
FranceSite Not Available
CHU Amiens, Hôpital Sud
Amiens, 80054
FranceSite Not Available
CH Avignon
Avignon, 84902
FranceSite Not Available
CH de la Côte Basque, Service d'Hématologie
Bayonne, 64109
FranceSite Not Available
Hématologie - CHU Jean Minjoz
Besancon, 25030
FranceSite Not Available
Institut Bergonié
Bordeaux, 33076
FranceSite Not Available
Hopital MORVAN - CHU Brest
Brest, 29609
FranceSite Not Available
Centre François Baclesse, Comite Hématologie
Caen, 14076
FranceSite Not Available
Hôpital Henri MONDOR
Creteil, 94010
FranceSite Not Available
CHD Vendée
La Roche-sur-Yon, 85925
FranceSite Not Available
CHRU Lille- Hospital Claude Huriez
Lille, 59037
FranceSite Not Available
Institut Paoli-Calmettes
Marseille, 13273
FranceSite Not Available
CHR Metz-Thionville
Metz, 57085
FranceSite Not Available
CH de Mulhouse - Hôpital Emile Muller
Mulhouse, 68100
FranceSite Not Available
Centre Antoine Lacassagne
Nice, 06189
FranceSite Not Available
CHR Orléans
Orleans, 45100
FranceSite Not Available
Institut Curie
Paris, 75005
FranceSite Not Available
Centre Hospitalier Saint Jean
Perpignan, 66000
FranceSite Not Available
Hôpital Haut-Levêque Centre F.Magendie
Pessac, 33600
FranceSite Not Available
Centre Hospitalier René Dubos,
Pontoise, 95303
FranceSite Not Available
Service d'Hématologie Centre Henri Becquerel
Rouen, 76038
FranceSite Not Available
CHU de Brabios
Vandoeuvre-les-nancy, 54511
FranceSite Not Available
St James 's Hospital
Dublin, 8
IrelandSite Not Available
University Hospital Galway
Galway,
IrelandSite Not Available
Soroka Medical Centre
Beersheba, 84101
IsraelSite Not Available
Rambam Health Care Campus
Haifa,
IsraelSite Not Available
Hadassah Medical Organization
Jerusalem, 91120
IsraelSite Not Available
Shaare Zedek Medical Center
Jerusalem, 93722
IsraelSite Not Available
Tel Aviv Sourasky Medical Centre
Tel Aviv, 64239
IsraelSite Not Available
Chaim Sheba Medical Center
Tel-Hashomer, 52621
IsraelSite Not Available
Policlinico S Orsola Malpighi, Istituto di Ematologia ''L.e A. Seragnoli''
Bologna, 40138
ItalySite Not Available
New Ematologia dell'Ospedale "Spedali Civili" di Brescia
Brescia, 25123
ItalySite Not Available
Divisione di Ematoncologia
Milano, 20141
ItalySite Not Available
Azienda Ospedaliera Sant'Andrea
Roma, 00189
ItalySite Not Available
Azienda Ospedaliera San. Giovanni Battista di Torino, Dipartimento di Oncologia U.O.A Ematologia, Le Molinette,
Torino, 10126
ItalySite Not Available
Meander Medisch Centrum
Amersfoort, 3813 TZ
NetherlandsSite Not Available
VU Medisch Centrum
Amsterdam, 1081
NetherlandsSite Not Available
Haga Ziekenhuis
Den Haag, 2545 CH
NetherlandsSite Not Available
University Medical Centre Groningen (UMCG)
Groningen, 9713GZ
NetherlandsSite Not Available
Spaarne Ziekenhuis, Internal Medicine/Ocology
Hoofddorp, 2134TM
NetherlandsSite Not Available
Medisch Centrum Leeuwarden
Leeuwarden, 8934 AD
NetherlandsSite Not Available
St. Antonius Hospital
Nieuwegein, 3435 CM
NetherlandsSite Not Available
University Medical Center Radboud Nijmegen
Nijmegen, 6525
NetherlandsSite Not Available
Erasmus Medisch Centrum
Rotterdam, NL-3015
NetherlandsSite Not Available
Auxilio Mutuo Cancer Center
San Juan, 00918
Puerto RicoSite Not Available
Clínica Universidad de Navarra (CUN)
Pamplona,
SpainSite Not Available
Hospital Universitario Miguel Servet
Zaragoza, 50009
SpainSite Not Available
Miguel Servet University Hospital
Zaragoza,
SpainSite Not Available
Department of Haematology Bristol Royal Infirmary
Bristol, BS2 8HW
United KingdomSite Not Available
Poole General Hospital
Dorset, BH15
United KingdomSite Not Available
Beatson Cancer Centre
Glasgow, G12 0YN
United KingdomSite Not Available
King's College Hospital
London, SE5 9RS
United KingdomSite Not Available
The Christie NHS Foundation Trust, The Christie Hospital,
Manchester, M20 4BX
United KingdomSite Not Available
Cancer Treatment Services Arizona
Casa Grande, Arizona 85122
United StatesSite Not Available
Sutter East Bay Hospitals
Berkeley, California 94704
United StatesSite Not Available
Sutter East Bay Hospitals
Berkley, California 94704
United StatesSite Not Available
City of Hope
Duarte, California 91010
United StatesSite Not Available
Halifax Health Medical Center
Daytona Beach, Florida 32114
United StatesSite Not Available
H. Lee Moffitt Cancer Center
Tampa, Florida 33612
United StatesSite Not Available
Piedmont Hospital Cancer Center
Atlanta, Georgia 30318
United StatesSite Not Available
St. Luke's Mountain States Tumor Institute (MSTI)
Boise, Idaho 83712
United StatesSite Not Available
Northwestern University Feinberg School of Medicine
Chicago, Illinois 60611
United StatesSite Not Available
Rush University Medical Center
Chicago, Illinois 60612
United StatesSite Not Available
Decatur Memorial Hospital Cancer Care Specialists of Central Illinois
Decatur, Illinois 62526
United StatesSite Not Available
Illinois Cancer Specialists
Niles, Illinois 60714
United StatesSite Not Available
Midwestern Regional Medical Center
Zion, Illinois 60099
United StatesSite Not Available
University of Iowa Hospitals and Clinics
Iowa City, Iowa 52242
United StatesSite Not Available
Norton Cancer Institute, Suburban
Louisville, Kentucky 40207
United StatesSite Not Available
Norton Cancer Institute, Suburban
Lousiville, Kentucky 40207
United StatesSite Not Available
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
United StatesSite Not Available
St. John Hospital and Medical Center
Grosse Pointe Woods, Michigan 48236
United StatesSite Not Available
Oncology Research-Park Nicollet Institute
Saint Louis Park, Minnesota 55426
United StatesSite Not Available
Oncology Research-Park Nicollet Institute
St. Louis Park, Minnesota 55426
United StatesSite Not Available
Saint Louis University
Saint Louis, Missouri 63110
United StatesSite Not Available
Saint Louis University
St. Louis, Missouri 63110
United StatesSite Not Available
Comprehensive Cancer Centers of Nevada
Henderson, Nevada 89044
United StatesSite Not Available
Hackensack UMC / John Theurer Cancer Center
Hackensack, New Jersey 07601
United StatesSite Not Available
Memorial Sloan-Kettering Cancer Center
New York, New York 10065
United StatesSite Not Available
Adams Cancer center
Gettysburg, Pennsylvania 17325
United StatesSite Not Available
York Cancer Center / Cancer Care Associates of York
York, Pennsylvania 17403
United StatesSite Not Available
Saint Francis Hospital
Greenville, South Carolina 29601
United StatesSite Not Available
Avera Hematology and Transplant
Sioux Falls, South Dakota 57105
United StatesSite Not Available
Associates In Oncology and Hematology
Chattanooga, Tennessee 37421
United StatesSite Not Available
The University of Texas M.D. Anderson Cancer Center
Houston, Texas 77030
United StatesSite Not Available
Seattle Cancer Care Alliance
Seattle, Washington 98109
United StatesSite Not Available
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