Trial record 1 of 1 for:    spi-zev-11-301
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Study of Zevalin Versus Observation in Patients at Least 60 Yrs Old With Newly Diagnosed Diffuse Large B-cell Lymphoma in PET-negative Complete Remission After R-CHOP or R-CHOP-like Therapy

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Spectrum Pharmaceuticals, Inc
Sponsor:
Information provided by (Responsible Party):
Spectrum Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT01510184
First received: January 6, 2012
Last updated: July 2, 2014
Last verified: July 2014
  Purpose

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


Condition Intervention Phase
Diffuse Large B-cell Lymphoma
Follicle Center Lymphoma
Drug: Zevalin (ibritumomab tiuxetan)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Spectrum Pharmaceuticals, Inc:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    The overall survival rate


Secondary Outcome Measures:
  • OS rate post randomization [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
    Overall Survival (OS) rate post randomization

  • Progression-free survival [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
    Progression-free survival (PFS)


Estimated Enrollment: 490
Study Start Date: April 2012
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Zevalin (ibritumomab tiuxetan)
Day 1: Rituximab 250 mg/m2 intravenous infusion Days 7-9:Rituximab 250 mg/m2 intravenous infusion followed by Y-90-Zevalin 14.8 MBq/kg. In centers where biodistribution imaging is performed Day 1: Rituximab 250 mg/m2 intravenous infusion followed by In-111-Zevalin 185 MBq (5mCi), Days 3-4: Biodistribution imaging Days 7-9: Rituximab 250 mg/m2 intravenous infusion followed by Y-90-Zevalin 14.8 MBq/kg
Drug: Zevalin (ibritumomab tiuxetan)
Day 1: Rituximab 250 mg/m2 intravenous infusion Days 7-9:Rituximab 250 mg/m2 intravenous infusion followed by Y-90-Zevalin 14.8 MBq/kg. In centers where biodistribution imaging is performed Day 1: Rituximab 250 mg/m2 intravenous infusion followed by In-111-Zevalin 185 MBq (5mCi), Days 3-4: Biodistribution imaging Days 7-9: Rituximab 250 mg/m2 intravenous infusion followed by Y-90-Zevalin 14.8 MBq/kg
No Intervention: Observation Arm
Patients randomized to the observation (control) arm will not receive any further anti-lymphoma therapy unless they have a relapse of their disease.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient is 60-years of age or older at time of randomization
  2. Histologically confirmed Ann Arbor stage II, III, or IV DLBCL; or FCL Grade 3B according to the REAL/WHO classification (from initial diagnosis made prior to starting R-CHOP therapy). Results from a pre R-CHOP marrow shall be available for review.
  3. Local pathology review confirming the DLBCL diagnosis and CD20 positivity, and no evidence of DLBCL in bone marrow upon confirmation of CR.
  4. A paraffin block or original slides available for confirmatory pathology review. Patients may be randomized based on the local pathology result.
  5. Age-adjusted IPI of 1, 2, or 3. The age adjusted IPI is defined by one point for LDH > upper limit of normal (ULN); Stage III or IV; and Karnofsky performance status <80% or WHO/ECOG performance status >1.
  6. First-line treatment of DLBCL must have been 6 cycles of standard R-CHOP21, R-CHOP14 or DA-EPOCH-R chemotherapy. Patients who received pre-phase therapy for the purpose of improving performance status prior to initiating R-CHOP are eligible.(See CRF Manual for further clarification).
  7. Complete remission (CR) according to the International Workshop Response Criteria for NHL described by Cheson et al (Appendix 2). after first-line treatment. 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 patient had involvement of the neck region by palpation / physical examination at first diagnosis.
  8. A negative FDG-PET scan confirming complete response, with negative defined as a score of 1-3 on the Deauville 5-point scale (Appendix 3) used to quantify radionucleotide density in PET scans as determined locally (Morschhauser 200735).
  9. 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 patients randomized to the Zevalin arm only.
  10. A WHO/ECOG performance status of 0, 1 or 2.
  11. Adequate hematopoietic functions: Absolute neutrophil count (ANC) ≥ 1.0 x 109/L, Hemoglobin (Hgb) ≥ 9 g/dL, Platelets ≥ 100 x 109/L.
  12. Life expectancy of 6 months or longer
  13. Written informed consent obtained according to local guidelines

Exclusion Criteria:

  1. Presence of any other malignancy or history of prior malignancy within 5 years of study entry. Within 5 years, patients treated for Stage I or II cancers are eligible provided they have a life expectancy of > 5 years (See CRF Manual for clarification). The 5-year exclusion rule does not apply to-non melanoma skin tumors and in situ cervical cancer.
  2. Prior radioimmunotherapy, including radiation therapy for NHL, or any other NHL therapy.
  3. Presence of primary gastric, central nervous system (CNS), or testicular lymphoma at first diagnosis.
  4. Histological transformation of low-grade NHL.
  5. Active hepatitis B or C. (See CRF completion manual)
  6. Known history of HIV infection.
  7. Abnormal liver function: total bilirubin > 2 × ULN unless secondary to Gilbert disease.
  8. Abnormal renal function: serum creatinine > 2.0 × ULN.
  9. Non-recovery from the toxic effects of chemotherapy to < grade 2, or interfering with Zevalin treatment.
  10. Known hypersensitivity to murine or chimeric antibodies or proteins
  11. G-CSF or GM-CSF therapy within 4 weeks prior to Zevalin or observation.
  12. 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.
  13. Treatment with investigational drugs less than 4 weeks prior to Zevalin or observation.
  14. Major surgery less than 4 weeks prior to Zevalin or start of observation.
  15. 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. Patients on a chronic dose of prednisone for a medical condition (e.g. Asthma or autoimmune disease) less than or equal to 20mg daily, stable for 4 weeks, are permissible.
  16. Unwillingness or inability to comply with the protocol.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01510184

Contacts
Contact: Denise Uy (949) 743-9303 denise.uy@sppirx.com

  Hide Study Locations
Locations
United States, Arizona
Cancer Treatment Services Arizona Recruiting
Casa Grande, Arizona, United States, 85122
Contact: Ajay Bhatnagar, MD, MD    520-374-9905      
Principal Investigator: Ajay Bhatnagar, MD         
United States, California
Sutter East Bay Hospitals Recruiting
Berkley, California, United States, 94704
Contact: Oleg Krijanavoski    510-204-6446    KrijanO@sutterhealth.org   
Principal Investigator: Oleg Krijanavoski         
City of Hope Recruiting
Duarte, California, United States, 91010
Contact: Auayporn Nademanee, MD    626-256-4673 ext 62691      
Principal Investigator: Auayporn Nademanee, MD         
United States, Florida
Halifax Health Medical Center Recruiting
Daytona Beach, Florida, United States, 32114
Contact: Gregory Favis, MD    386-254-4213      
Principal Investigator: Gregory Favis, MD         
H. Lee Moffitt Cancer Center Active, not recruiting
Tampa, Florida, United States, 33612
United States, Georgia
Piedmont Hospital Cancer Center Withdrawn
Atlanta, Georgia, United States, 30318
United States, Idaho
St. Luke's Mountain States Tumor Institute (MSTI) Recruiting
Boise, Idaho, United States, 83712
Contact: Paul Montgomery, MD    208-381-3376      
Principal Investigator: Paul Montgomery, MD         
United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Tami Burge       Tonya_Burge@rush.edu   
Principal Investigator: Parameswaran Venugopal, MD         
Northwestern University Feinberg School of Medicine Recruiting
Chicago, Illinois, United States, 60611
Contact: Jennifer Dillman    312-695-1377    Jennifer.dillman@northwestern.edu   
Principal Investigator: Jane Winter, MD         
Decatur Memorial Hospital Cancer Care Specialists of Central Illinois Recruiting
Decatur, Illinois, United States, 62526
Contact: Cindy Stuckey    217-876-4758      
Principal Investigator: James Wade, III, MD         
Illinois Cancer Specialists Recruiting
Niles, Illinois, United States, 60714
Contact: Leonard Klein, MD    847-827-9060      
Principal Investigator: Leonard Klein, MD         
Midwestern Regional Medical Center Recruiting
Zion, Illinois, United States, 60099
Contact: Tanya Jordan       Tanya.jordan@ctca-hope.com   
Principal Investigator: Istvan Redei         
United States, Iowa
University of Iowa Hospitals and Clinics Recruiting
Iowa City, Iowa, United States, 52242
Contact: Lori Rosenstein, MD    319-467-5827      
Principal Investigator: Lori Rosenstein, MD         
Principal Investigator: Brian Link, MD         
United States, Kentucky
Norton Cancer Institute, Suburban Recruiting
Lousiville, Kentucky, United States, 40207
Contact: Don Stevens, MD    502-629-3704      
Principal Investigator: Don Stevens, MD         
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Robin Joyce, MD         
Principal Investigator: Robin Joyce, MD         
United States, Michigan
St. John Hospital and Medical Center Recruiting
Grosse pointe Woods, Michigan, United States, 48236
Contact: Mary Steigelman       Mary.Steigelman@stjohn.org   
Principal Investigator: Zyad Kafri, MD         
United States, Minnesota
Oncology Research-Park Nicollet Institute Recruiting
St. Louis Park, Minnesota, United States, 55426
Contact: Laura Maybon       Laura.Maybon@ParkNicollet.com   
Principal Investigator: Rachel Lerner, MD         
United States, Missouri
Saint Louis University Recruiting
St. Louis, Missouri, United States, 63110
Contact: Mark Fesler, MD    314-268-7061      
Principal Investigator: Mark Fesler, MD         
United States, Nevada
Comprehensive Cancer Centers of Nevada Recruiting
Henderson, Nevada, United States, 89044
Principal Investigator: Matthew Schwartz, MD         
United States, New Jersey
Hackensack UMC / John Theurer Cancer Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Tatyana Feldman, MD    201-996-3033      
Principal Investigator: Tatyana Feldman, MD         
United States, New York
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Paul Hamlin    212-639-6143    hamlinp@MSKCC.org   
Principal Investigator: Paul Hamlin, MD         
United States, Pennsylvania
Adams Cancer center Recruiting
Gettysburg, Pennsylvania, United States, 17325
Contact: Sherif Yacoub, MD         
Principal Investigator: Sherif Yacoub, MD         
York Cancer Center / Cancer Care Associates of York Recruiting
York, Pennsylvania, United States, 17403
Contact: Amit Shah, M.D.    717-741-9229      
Principal Investigator: Amit Shah, M.D.         
United States, South Carolina
Saint Francis Hospital Recruiting
Greenville, South Carolina, United States, 29601
Contact: Kristina Stoeppler-Biege    864-255-1517    kristina_stoeppler-biege@bshsi.org   
Principal Investigator: Gary Spitzer, MD         
Principal Investigator: Fahd Quddus, MD         
United States, South Dakota
Avera Hematology and Transplant Recruiting
Sioux Falls, South Dakota, United States, 57105
Contact: Kelly McCaul, M.D.    605-322-3056      
Principal Investigator: Kelly McCaul, M.D.         
United States, Tennessee
Associates In Oncology and Hematology Recruiting
Chattanooga, Tennessee, United States, 37421
Contact: Jitendra Gandhi, MD    423-622-2337      
Principal Investigator: Jitendra Gandhi, MD         
United States, Texas
The University of Texas M.D. Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Jason Westin, MD         
Principal Investigator: Luis Fayad, MD         
Principal Investigator: Jason Westin, MD         
United States, Washington
Seattle Cancer Care Alliance Recruiting
Seattle, Washington, United States, 98109
Contact: Tove Thompson    206-288-1233      
Principal Investigator: Ajay Gopal, MD         
Australia, Tasmania
Royal Hobart Hospital Recruiting
Hobart, Tasmania, Australia, 7001
Contact: Anna Johnston, MD         
Principal Investigator: Anna Johnston, MD         
Australia, Victoria
Royal Melbourne Recruiting
Parkville, Victoria, Australia, 3052
Contact: Kyle Mason       Kylie.Mason@mh.org.au   
Principal Investigator: Kylie Mason         
Australia
Royal Adelaide Hospital Recruiting
Adelaide, Australia
Contact: Pratyush Giri       pratyush.Giri@health.sa.gov.au   
Principal Investigator: Pratyush Giri         
Barwon Health Recruiting
Geelong, Australia, 3220
Contact: Philip Campbell       PHILIPC@BarwonHealth.org.au   
Principal Investigator: Philip Campbell         
Western Hospital Recruiting
Melbourne, Australia
Contact: William Renwick       william.renwick@mh.org.au   
Principal Investigator: William Renwick         
Austria
Medizinische Universität Wien -AKH Wien Recruiting
Vienna, Austria, A-1090
Contact: Markus Raderer, MD         
Principal Investigator: Markus Raderer, Prof.MD         
Belgium
Nuclear Medicine Physician, Jules Bordet Institute Recruiting
Bruxelles, Belgium, 1000
Contact: Kristoff Muylle       kristoff.muylle@bordet.be   
Principal Investigator: Kristoff Muylle         
University Hospital Gasthuisberg Recruiting
Leuven, Belgium, 3000
Contact: Gregor Verhoef       gregor.verhoef@uz.kuleuven.ac.be   
Principal Investigator: Prof Gregor E.G. Verhoef         
Canada, Ontario
Thunder Bay Regional Health Sciences Centre-Regional Cancer Care Recruiting
Thunder Bay, Ontario, Canada, P7B 6V4
Contact: Nicole Laferriere         
Principal Investigator: Nicole Laferriere, MD         
Sunnybrook Research Institute Recruiting
Toronto, Ontario, Canada
Contact: Neil Berinstein, MD    416-480-5248      
Principal Investigator: Neil Berinstein, MD         
Canada, Quebec
CSSS Champlain Charles LeMoyne Recruiting
Greenfield Park, Quebec, Canada, J4V2H1
Contact: Veronique Machebee    450-466-5000      
Principal Investigator: Céline Devaux, MD         
France
CHU A Michallon Recruiting
Grenoble, Cedex 9, France, 38043
Contact: Rémy Gressin, MD         
Principal Investigator: Rémy Gressin, MD         
CHU Dupuytren Recruiting
Limoges, Cedex, France, 87042
Contact: Dominique Bordessoule         
Principal Investigator: Dominique Bordessoule         
CHU Amiens, Hôpital Sud Recruiting
Amiens, France, 80054
Contact: Jean-Pierre MAROLLEAU         
Principal Investigator: Jean-Pierre MAROLLEAU         
CH Avignon Recruiting
Avignon, France, 84902
Contact: Borhane Slama         
Principal Investigator: Borhane Slama         
CH de la Côte Basque, Service d'Hématologie Recruiting
Bayonne, France, 64109
Contact: Anne Banos, MD         
Principal Investigator: Anne Banos, MD         
Hématologie - CHU Jean Minjoz Recruiting
Besancon, France, 25030
Contact: Eric Deconinck         
Principal Investigator: Eric Deconinck         
Institut Bergonié Recruiting
Bordeaux, France, 33076
Contact: Fontanet BIJOU         
Principal Investigator: Fontanet BIJOU         
Hopital MORVAN - CHU Brest Recruiting
Brest, France, 29609
Contact: Adrian TEMPESCUL         
Principal Investigator: Adrian TEMPESCUL         
Centre François Baclesse, Comite Hématologie Recruiting
Caen, France, 14076
Contact: Christophe Fruchart, MD         
Principal Investigator: Christophe Fruchart, MD         
Hôpital Henri MONDOR Recruiting
Creteil, France, 94010
Contact: Corinne HAIOUN         
Principal Investigator: Corinne HAIOUN         
CHD Vendée Recruiting
La Roche-sur-Yon, France, 85925
Contact: Hervé MAISONNEUVE         
Principal Investigator: Hervé MAISONNEUVE         
CHRU Lille- Hospital Claude Huriez Recruiting
Lille, France, 59037
Contact: Franck Morschhauser, MD         
Principal Investigator: Franck Morschhauser, MD         
Institut Paoli-Calmettes Recruiting
Marseille, France, 13273
Contact: Réda BOUABDALLAH, MD         
Principal Investigator: Réda BOUABDALLAH, MD         
CHR Metz-Thionville Recruiting
Metz, France, 57085
Contact: Alina ZAMFIR         
Principal Investigator: Alina ZAMFIR         
CH de Mulhouse - Hôpital Emile Muller Recruiting
Mulhouse, France, 68100
Contact: Bernard Drenou, MD         
Principal Investigator: Bernard Drenou, MD         
Centre Antoine Lacassagne Recruiting
Nice, France, 06189
Contact: Frédéric Peyrade         
Principal Investigator: Frédéric Peyrade, MD         
CHR Orléans Recruiting
Orleans, France, 45100
Contact: Omar BENBRAHIM         
Principal Investigator: Omar BENBRAHIM         
Institut Curie Recruiting
Paris, France, 75005
Contact: Frederique Kuhnowski, MD         
Principal Investigator: Frederique Kuhnowski, MD         
Centre Hospitalier Saint Jean Recruiting
Perpignan, France, 66000
Contact: Sanhes Laurence, MD         
Principal Investigator: Sanhes Laurence, MD         
Hôpital Haut-Levêque Centre F.Magendie Recruiting
Pessac, France, 33600
Contact: Kamal Bouabdallah         
Principal Investigator: Kamal Bouabdallah, MD         
Centre Hospitalier René Dubos, Recruiting
Pontoise, France, 95303
Contact: Hugo Gonzalez, MD         
Principal Investigator: Hugo Gonzalez, MD         
Service d'Hématologie Centre Henri Becquerel Recruiting
Rouen, France, 76038
Contact: Hervé TILLY         
Principal Investigator: Hervé TILLY         
CHU de Brabios Recruiting
Vandoeuvre-les-nancy, France, 54511
Contact: Serge Bologna, MD         
Principal Investigator: Serge Bologna, MD         
Ireland
St James 's Hospital Recruiting
Dublin, Ireland, 8
Contact: Elisabeth Vandenberghe       evandenberghe@STJAMES.IE   
Principal Investigator: Elisabeth Vandenberghe         
University Hospital Galway Recruiting
Galway, Ireland
Contact: Amjad Hayat       amjad.hayat@hse.ie   
Principal Investigator: Amjad Hayat         
Israel
Soroka Medical Centre Recruiting
Beersheba, Israel, 84101
Contact: Etai Levi       etail@clalit.org.il   
Principal Investigator: Etai Levi         
Rambam Health Care Campus Recruiting
Haifa, Israel
Contact: Irit Avivi       i_avivi@rambam.health.gov.il   
Principal Investigator: Irit Avivi         
Shaare Zedek Medical Center Recruiting
Jerusalem, Israel, 93722
Contact: Jacob Rowe       rowe@rambam.health.gov.il   
Principal Investigator: Jacob Rowe         
Hadassah Medical Organization Recruiting
Jerusalem, Israel, 91120
Contact: Prof. Dina Ben-Yehuda       dbyehuda@hadassah.org.il   
Principal Investigator: Prof. Dina Ben-Yehuda         
Tel Aviv Sourasky Medical Centre Recruiting
Tel Aviv, Israel, 64239
Contact: Ilya Kirgner       ilyak@tasmc.health.gov.il   
Principal Investigator: Ilya Kirgner         
Chaim Sheba Medical Center Recruiting
Tel-Hashomer, Israel, 52621
Contact: Arnon Nagler       Arnon.Nagler@sheba.health.gov.il   
Principal Investigator: Arnon Nagler         
Italy
Policlinico S Orsola Malpighi, Istituto di Ematologia ''L.e A. Seragnoli'' Recruiting
Bologna, Italy, 40138
Contact: Pier Luigi Zinzani, Prof.       pierluigi.zinzani@unibo.it   
Principal Investigator: Pier Luigi Zinzani, Prof.         
New Ematologia dell'Ospedale "Spedali Civili" di Brescia Recruiting
Brescia, Italy, 25123
Contact: Giuseppe Rossi       rossig@med.unibs.it   
Principal Investigator: Giuseppe Rossi         
Divisione di Ematoncologia Recruiting
Milano, Italy, 20141
Contact: Giovanni Martinelli       giovanni.martinelli@ieo.it   
Principal Investigator: Giovanni Martinelli         
Azienda Ospedaliera Sant'Andrea Recruiting
Roma, Italy, 00189
Contact: Christina Cox       chrisscox@gmail.com   
Principal Investigator: Christina Cox         
Azienda Ospedaliera San. Giovanni Battista di Torino, Dipartimento di Oncologia U.O.A Ematologia, Le Molinette, Recruiting
Torino, Italy, 10126
Contact: Dott Umberto Vitolo       uvitolo@cittadellasalute.to.it   
Principal Investigator: Dott Umberto Vitolo         
Netherlands
Meander Medisch Centrum Recruiting
Amersfoort, Netherlands, 3813 TZ
Contact: Rob Fijnheer, MD         
Principal Investigator: Rob Fijnheer, MD         
VU Medisch Centrum Recruiting
Amsterdam, Netherlands, 1081
Contact: Josee Zijlstra         
Principal Investigator: Josee Zijlstra, MD         
Haga Ziekenhuis Recruiting
Den Haag, Netherlands, 2545 CH
Contact: Lara Bohmer         
Principal Investigator: Lara Bohmer         
University Medical Centre Groningen (UMCG) Recruiting
Groningen, Netherlands, 9713GZ
Contact: Gustaaf Willem Van Imhoff, MD, PhD         
Principal Investigator: Gustaaf Willem Van Imhoff, MD, PhD         
Spaarne Ziekenhuis, Internal Medicine/Ocology Recruiting
Hoofddorp, Netherlands, 2134TM
Contact: Aart Beeker, MD         
Principal Investigator: Aart Beeker, MD         
Medisch Centrum Leeuwarden Recruiting
Leeuwarden, Netherlands, 8934 AD
Contact: Mels Hoogendoorn, MD         
Principal Investigator: Mels Hoogendoorn, MD         
St. Antonius Hospital Recruiting
Nieuwegein, Netherlands, 3435 CM
Contact: Harry Koene, MD         
Principal Investigator: Harry Koene, MD         
University Medical Center Radboud Nijmegen Recruiting
Nijmegen, Netherlands, 6525
Contact: Wendy Stevens         
Principal Investigator: Wendy Stevens         
Erasmus Medisch Centrum Recruiting
Rotterdam, Netherlands, NL-3015
Contact: Elly Lugtenburg       p.lugtenburg@erasmusmc.nl   
Principal Investigator: Dr Elly Lugtenburg         
Puerto Rico
Auxilio Mutuo Cancer Center Recruiting
San Juan, Puerto Rico, 00918
Contact: Idalia Liboy, MD       iliboy@auxiliomutuo.com   
Principal Investigator: Fernando Cabanillas, MD         
Spain
Clínica Universidad de Navarra (CUN) Recruiting
Pamplona, Spain
Contact: Carlos Panizo       cpanizo@unav.es   
Miguel Servet University Hospital Recruiting
Zaragoza, Spain
Contact: Pilar Giraldo       giraldo.p@gmail.com   
Principal Investigator: Pilar Giraldo         
Hospital Universitario Miguel Servet Recruiting
Zaragoza, Spain, 50009
Contact: Teresa Baringo Fuentes, MD         
Principal Investigator: Teresa Baringo Fuentes, MD         
United Kingdom
Department of Haematology Bristol Royal Infirmary Recruiting
Bristol, United Kingdom, BS2 8HW
Contact: Matthew Beasley       matthew.beasley@UHBristol.nhs.uk   
Principal Investigator: Matthew Beasley         
Poole General Hospital Recruiting
Dorset, United Kingdom, BH15
Contact: Mike Bayne       mike.bayne@poole.nhs.uk   
Principal Investigator: Mike Bayne         
Beatson Cancer Centre Recruiting
Glasgow, United Kingdom, G12 0YN
Contact: Noelle O'Rourke       Noelle.O'Rourke@ggc.scot.nhs.uk   
Principal Investigator: Noelle O'Rourke         
King's College Hospital Recruiting
London, United Kingdom, SE5 9RS
Contact: Robert Marcus, MD         
Principal Investigator: Robert Marcus, MD         
The Christie NHS Foundation Trust, The Christie Hospital, Recruiting
Manchester, United Kingdom, M20 4BX
Contact: Tim Illidge       tillidge@picr.man.ac.uk   
Principal Investigator: Tim Illidge         
Sponsors and Collaborators
Spectrum Pharmaceuticals, Inc
Investigators
Study Director: Denise Kim, MD Spectrum Pharmaceuticals, Inc
  More Information

No publications provided

Responsible Party: Spectrum Pharmaceuticals, Inc
ClinicalTrials.gov Identifier: NCT01510184     History of Changes
Other Study ID Numbers: SPI-ZEV-11-301
Study First Received: January 6, 2012
Last Updated: July 2, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Follicular
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014