Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Trial record 1 of 1 for:    spi-zev-11-301
Previous Study | Return to List | Next Study

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 has been terminated.
Sponsor:
Information provided by (Responsible Party):
Spectrum Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:
NCT01510184
First received: January 6, 2012
Last updated: August 11, 2014
Last verified: August 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)


Enrollment: 81
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

  Hide Study Locations
Locations
United States, Arizona
Cancer Treatment Services Arizona
Casa Grande, Arizona, United States, 85122
United States, California
Sutter East Bay Hospitals
Berkley, California, United States, 94704
City of Hope
Duarte, California, United States, 91010
United States, Florida
Halifax Health Medical Center
Daytona Beach, Florida, United States, 32114
H. Lee Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, Georgia
Piedmont Hospital Cancer Center
Atlanta, Georgia, United States, 30318
United States, Idaho
St. Luke's Mountain States Tumor Institute (MSTI)
Boise, Idaho, United States, 83712
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611
Decatur Memorial Hospital Cancer Care Specialists of Central Illinois
Decatur, Illinois, United States, 62526
Illinois Cancer Specialists
Niles, Illinois, United States, 60714
Midwestern Regional Medical Center
Zion, Illinois, United States, 60099
United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
United States, Kentucky
Norton Cancer Institute, Suburban
Lousiville, Kentucky, United States, 40207
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Michigan
St. John Hospital and Medical Center
Grosse pointe Woods, Michigan, United States, 48236
United States, Minnesota
Oncology Research-Park Nicollet Institute
St. Louis Park, Minnesota, United States, 55426
United States, Missouri
Saint Louis University
St. Louis, Missouri, United States, 63110
United States, Nevada
Comprehensive Cancer Centers of Nevada
Henderson, Nevada, United States, 89044
United States, New Jersey
Hackensack UMC / John Theurer Cancer Center
Hackensack, New Jersey, United States, 07601
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
United States, Pennsylvania
Adams Cancer center
Gettysburg, Pennsylvania, United States, 17325
York Cancer Center / Cancer Care Associates of York
York, Pennsylvania, United States, 17403
United States, South Carolina
Saint Francis Hospital
Greenville, South Carolina, United States, 29601
United States, South Dakota
Avera Hematology and Transplant
Sioux Falls, South Dakota, United States, 57105
United States, Tennessee
Associates In Oncology and Hematology
Chattanooga, Tennessee, United States, 37421
United States, Texas
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
United States, Washington
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
Australia, Tasmania
Royal Hobart Hospital
Hobart, Tasmania, Australia, 7001
Australia, Victoria
Royal Melbourne
Parkville, Victoria, Australia, 3052
Australia
Royal Adelaide Hospital
Adelaide, Australia
Barwon Health
Geelong, Australia, 3220
Western Hospital
Melbourne, Australia
Austria
Medizinische Universität Wien -AKH Wien
Vienna, Austria, A-1090
Belgium
Nuclear Medicine Physician, Jules Bordet Institute
Bruxelles, Belgium, 1000
University Hospital Gasthuisberg
Leuven, Belgium, 3000
Canada, Ontario
Thunder Bay Regional Health Sciences Centre-Regional Cancer Care
Thunder Bay, Ontario, Canada, P7B 6V4
Sunnybrook Research Institute
Toronto, Ontario, Canada
Canada, Quebec
CSSS Champlain Charles LeMoyne
Greenfield Park, Quebec, Canada, J4V2H1
France
CHU A Michallon
Grenoble, Cedex 9, France, 38043
CHU Dupuytren
Limoges, Cedex, France, 87042
CHU Amiens, Hôpital Sud
Amiens, France, 80054
CH Avignon
Avignon, France, 84902
CH de la Côte Basque, Service d'Hématologie
Bayonne, France, 64109
Hématologie - CHU Jean Minjoz
Besancon, France, 25030
Institut Bergonié
Bordeaux, France, 33076
Hopital MORVAN - CHU Brest
Brest, France, 29609
Centre François Baclesse, Comite Hématologie
Caen, France, 14076
Hôpital Henri MONDOR
Creteil, France, 94010
CHD Vendée
La Roche-sur-Yon, France, 85925
CHRU Lille- Hospital Claude Huriez
Lille, France, 59037
Institut Paoli-Calmettes
Marseille, France, 13273
CHR Metz-Thionville
Metz, France, 57085
CH de Mulhouse - Hôpital Emile Muller
Mulhouse, France, 68100
Centre Antoine Lacassagne
Nice, France, 06189
CHR Orléans
Orleans, France, 45100
Institut Curie
Paris, France, 75005
Centre Hospitalier Saint Jean
Perpignan, France, 66000
Hôpital Haut-Levêque Centre F.Magendie
Pessac, France, 33600
Centre Hospitalier René Dubos,
Pontoise, France, 95303
Service d'Hématologie Centre Henri Becquerel
Rouen, France, 76038
CHU de Brabios
Vandoeuvre-les-nancy, France, 54511
Ireland
St James 's Hospital
Dublin, Ireland, 8
University Hospital Galway
Galway, Ireland
Israel
Soroka Medical Centre
Beersheba, Israel, 84101
Rambam Health Care Campus
Haifa, Israel
Hadassah Medical Organization
Jerusalem, Israel, 91120
Shaare Zedek Medical Center
Jerusalem, Israel, 93722
Tel Aviv Sourasky Medical Centre
Tel Aviv, Israel, 64239
Chaim Sheba Medical Center
Tel-Hashomer, Israel, 52621
Italy
Policlinico S Orsola Malpighi, Istituto di Ematologia ''L.e A. Seragnoli''
Bologna, Italy, 40138
New Ematologia dell'Ospedale "Spedali Civili" di Brescia
Brescia, Italy, 25123
Divisione di Ematoncologia
Milano, Italy, 20141
Azienda Ospedaliera Sant'Andrea
Roma, Italy, 00189
Azienda Ospedaliera San. Giovanni Battista di Torino, Dipartimento di Oncologia U.O.A Ematologia, Le Molinette,
Torino, Italy, 10126
Netherlands
Meander Medisch Centrum
Amersfoort, Netherlands, 3813 TZ
VU Medisch Centrum
Amsterdam, Netherlands, 1081
Haga Ziekenhuis
Den Haag, Netherlands, 2545 CH
University Medical Centre Groningen (UMCG)
Groningen, Netherlands, 9713GZ
Spaarne Ziekenhuis, Internal Medicine/Ocology
Hoofddorp, Netherlands, 2134TM
Medisch Centrum Leeuwarden
Leeuwarden, Netherlands, 8934 AD
St. Antonius Hospital
Nieuwegein, Netherlands, 3435 CM
University Medical Center Radboud Nijmegen
Nijmegen, Netherlands, 6525
Erasmus Medisch Centrum
Rotterdam, Netherlands, NL-3015
Puerto Rico
Auxilio Mutuo Cancer Center
San Juan, Puerto Rico, 00918
Spain
Clínica Universidad de Navarra (CUN)
Pamplona, Spain
Hospital Universitario Miguel Servet
Zaragoza, Spain, 50009
Miguel Servet University Hospital
Zaragoza, Spain
United Kingdom
Department of Haematology Bristol Royal Infirmary
Bristol, United Kingdom, BS2 8HW
Poole General Hospital
Dorset, United Kingdom, BH15
Beatson Cancer Centre
Glasgow, United Kingdom, G12 0YN
King's College Hospital
London, United Kingdom, SE5 9RS
The Christie NHS Foundation Trust, The Christie Hospital,
Manchester, United Kingdom, M20 4BX
Sponsors and Collaborators
Spectrum Pharmaceuticals, Inc
Investigators
Study Director: Denise Kim, MD Spectrum Pharmaceuticals, Inc
Study Chair: Allen Lee, 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: August 11, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

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

ClinicalTrials.gov processed this record on November 25, 2014