Single Agent Ofatumumab Vs. Single Agent Rituximab in Indolent B-Cell Non Hodgkin Lymphoma Relapsed After Rituximab-Containing Therapy (HOMER)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2016 by Novartis
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT01200589
First received: September 10, 2010
Last updated: March 22, 2016
Last verified: March 2016
  Purpose
This is a multi-center, parallel, active comparator controlled, open-label, randomized (1:1) phase III study of single agent ofatumumab compared to single agent rituximab in subjects with rituximab-sensitive indolent B-cell non hodgkin lymphoma that has relapsed at least 6 months after completing treatment with single agent rituximab or a rituximab-containing regimen. Subjects must have attained a Complete Response or Partial Response to their last prior rituximab containing therapy lasting at least six months beyond the end of rituximab therapy. Subjects will receive four weekly doses of single agent ofatumumab (1000 mg) or rituximab (375 mg/m2), followed by ofatumumab (1000 mg) or rituximab (375 mg/m2) every 2 months for four additional doses. Therefore, subjects will receive a total of eight doses of anti-CD20 antibody over 9 months. Subjects will be evaluated for response after completion of the first four doses of therapy, after six doses of therapy, and after completion of study therapy. Subjects will be followed until the end of the designated follow-up period (total study duration of 200 weeks) or until they meet the withdrawal criteria.

Condition Intervention Phase
Non-Hodgkin's Lymphoma
Biological: Ofatumumab
Biological: Rituximab
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: Phase III Randomized, Open Label Study of Single Agent Ofatumumab Vs. Single Agent Rituximab in Indolent B-Cell Non Hodgkin Lymphoma Relapsed After Rituximab-Containing Therapy

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: 200 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • complete response rate [ Time Frame: 44 weeks ] [ Designated as safety issue: No ]
  • overall response rate [ Time Frame: 44 weeks ] [ Designated as safety issue: No ]
  • duration of response [ Time Frame: 200 weeks ] [ Designated as safety issue: No ]
  • time to next treatment [ Time Frame: 200 weeks ] [ Designated as safety issue: No ]
  • overall survival [ Time Frame: 200 weeks ] [ Designated as safety issue: Yes ]
  • infectious toxicity [ Time Frame: 44 weeks ] [ Designated as safety issue: Yes ]
  • pharmacokinetics [ Time Frame: 70 weeks ] [ Designated as safety issue: No ]
  • infusion related events [ Time Frame: 36 weeks ] [ Designated as safety issue: Yes ]
  • hematological toxicity [ Time Frame: 44 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 516
Study Start Date: October 2010
Estimated Study Completion Date: September 2020
Estimated Primary Completion Date: September 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A: Ofatumumab
Four weekly doses of single agent ofatumumab (1000 mg), followed by ofatumumab (1000 mg) every two months for four additional doses.
Biological: Ofatumumab
Four weekly doses of single agent ofatumumab (1000 mg), followed by ofatumumab (1000 mg) every two months for four additional doses.
Other Name: Arzerra
Active Comparator: Arm B: Rituximab
Four weekly doses of single agent rituximab (375 mg/m2), followed by rituximab (375 mg/m2) every two months for four additional doses.
Biological: Rituximab
Four weekly doses of single agent rituximab (375 mg/m2), followed by rituximab (375 mg/m2) every two months for four additional doses.
Other Names:
  • Mabthera
  • Rituxan

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Indolent NHL subtypes defined according to World Health Organization guidelines:

    1. Follicular lymphoma Grades 1, 2, 3 A
    2. Small lymphocytic lymphoma (SLL)
    3. Marginal zone lymphoma
    4. Lymphoplasmacytic lymphoma
  2. Rituximab-sensitive iNHL, defined as a partial or complete response to their last prior treatment with rituximab or a rituximab-containing regimen lasting at least 6 months following completion of rituximab treatment.
  3. Relapse or disease progression following response to prior rituximab-based therapy, as defined by 2007 RRCML criteria, which requires therapy.
  4. Radiographically measurable disease, defined as: 2 or more clearly demarcated lesions/nodes with a long axis >1.5 cm and short axis ≥1.0cm. OR 1 clearly demarcated lesion/node with a long axis >2.0 cm and short axis ≥1.0cm.
  5. ECOG Performance Status of 0, 1, or 2.
  6. Age ≥18 years.
  7. Life expectancy of at least 6 months in the opinion of the investigator.
  8. The patient or their legally acceptable representative must be capable of giving written informed consent prior to performing any study-specific tests or procedures.
  9. All prior treatment related non-hematologic toxicities (with the exception of alopecia) must have resolved to CTCAE (Version 4.0) ≤ Grade 2 at the time of randomization.
  10. One or more of the following indications for treatment:

    1. Cytopenias
    2. One or more of the following lymphoma-related symptoms:

      • Night sweats without signs of infection
      • Unintentional weight loss (10% within the previous 6 months)
      • Recurrent, unexplained fever of greater than 100.5F (38C) without signs of infection
      • Fatigue which interferes with the patient's quality of life
    3. Progressive or massive lymphadenopathy OR
    4. Progressive or massive organomegaly French subjects: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.

Exclusion Criteria:

  1. Previous treatment with ofatumumab.
  2. Previous anti-CD20 radioimmunotherapy (RIT) or non-rituximab anti-CD20 therapy (such as obinutuzumab) within 6 months prior to randomization. Patients who have received previous anti-CD20 RIT or non-rituximab anti-CD20 therapy (such as obinutuzumab) must have attained a partial or complete response lasting at least 6 months, and must have recovered from any hematologic or other toxicity.
  3. Previous autologous stem cell transplantation within 6 months prior to randomization.
  4. Previous allogeneic stem cell transplantation.
  5. Previous anti-lymphoma monoclonal antibody therapy (excluding anti-CD20 therapy and anti-CD20 RIT), chemotherapy, glucocorticoid, or other systemic therapy for lymphoma within 3 months prior to randomization.
  6. Current or previous participation in the treatment phase of another interventional clinical study within 4 weeks prior to randomization. Patients may continue in the follow-up phase of another interventional clinical study, but may not have undergone any treatment on the other study within 4 weeks prior to randomization.
  7. Current or previous other malignancy within 2 years prior to randomization. Subjects who have been free of malignancy for at least 2 years, or have a history of completely resected non-melanoma skin cancer or successfully treated carcinoma in situ, are eligible.
  8. Chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment such as, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis, tuberculosis, active Hepatitis C, and known HIV disease. All HIV-positive patients are excluded from this study, regardless of whether they have an Acquired Immunodeficiency Syndrome (AIDS) defining disease and/or are on antiviral therapy. Prophylactic antiviral and/or antibacterial antibiotics to prevent recurrence of previous infections are permitted.
  9. Clinically significant cardiac disease as judged by the investigator including unstable angina, acute myocardial infarction within 6 months prior to randomization, uncontrolled congestive heart failure, and uncontrolled arrhythmia. Subjects with congestive heart disease or arrhythmias such as atrial fibrillation whose cardiac disease is well controlled on a stable medical regimen are eligible.
  10. Other significant concurrent, uncontrolled medical conditions including, but not limited to, renal, hepatic, autoimmune, hematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease which, in the investigator's opinion, will impact study participation.
  11. Screening laboratory values:

    1. Neutrophils < 1.5 x 10^9/L (unless due to iNHL involvement of the bone marrow)
    2. Platelets < 50 x 10^9/L (unless due to iNHL involvement of the bone marrow)
    3. ALT or AST > 3 x ULN
    4. Alkaline phosphatase > 1.5 x ULN (unless due to lymphoma or a non-malignant, non-hepatic cause such as Paget's disease)
    5. Total bilirubin > 1.5 x ULN (unless due to lymphoma or isolated, predominantly indirect hyperbilirubinemia due to Gilbert's syndrome)
  12. Known or suspected inability to fully comply with study protocol
  13. Because the effects of ofatumumab on fetuses and nursing infants are not known, the following are ineligible for study entry:

    1. Lactating women.
    2. Women with a positive pregnancy test at study entry.
    3. Men with partners of childbearing potential and women of childbearing potential who are not willing to use adequate contraception from study entry through one year following last treatment dose. (Adequate contraception is defined as abstinence, oral hormonal birth control, hormonal birth control injections, implants of levonorgestrel, estrogenic vaginal ring, percutaneous contraceptive patches, intrauterine device, and male partner sterilization if male partner is the sole partner for a female subject. The double barrier method can be used in regions where considered acceptable and adequate, defined as condom or occlusive cap plus spermicidal agent).
  14. Current active liver or biliary disease (with the exception of Gilbert's syndrome or asymptomatic gallstones).
  15. Positive serology for Hepatitis B (HB) defined as a positive test for HBsAg. In addition, if negative for HBsAg but HBcAb positive (regardless of HBsAb status), a HB DNA test will be performed and if positive the subject will be excluded.
  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: NCT01200589

Contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals +41613241111

  Hide Study Locations
Locations
United States, Alaska
Novartis Investigative Site Not yet recruiting
Anchorage, Alaska, United States, 99508
United States, Arizona
Novartis Investigative Site Recruiting
Gilbert, Arizona, United States, 85234
United States, Arkansas
Novartis Investigative Site Terminated
Hot Springs, Arkansas, United States, 71913
United States, California
Novartis Investigative Site Recruiting
Greenbrae, California, United States, 94904
Novartis Investigative Site Recruiting
Monterey, California, United States, 93940
Novartis Investigative Site Completed
Pleasant Hill, California, United States, 94523
Novartis Investigative Site Recruiting
Rancho Mirage, California, United States, 92270
Novartis Investigative Site Not yet recruiting
Salinas, California, United States, 93901
Novartis Investigative Site Recruiting
San Diego, California, United States, 92123
Novartis Investigative Site Terminated
San Pablo, California, United States, 94806
Novartis Investigative Site Terminated
Santa Monica, California, United States, 90403
United States, Connecticut
Novartis Investigative Site Terminated
New Milford, Connecticut, United States, 06776
Novartis Investigative Site Terminated
Torrington, Connecticut, United States, 06790
United States, Florida
Novartis Investigative Site Recruiting
Lakeland, Florida, United States, 33805
Novartis Investigative Site Terminated
Orlando, Florida, United States, 32806
Novartis Investigative Site Recruiting
Pembroke Pines, Florida, United States, 33028
Novartis Investigative Site Recruiting
Port St. Lucie, Florida, United States, 34952
Novartis Investigative Site Recruiting
West Palm Beach, Florida, United States, 33401
United States, Georgia
Novartis Investigative Site Recruiting
Macon, Georgia, United States, 31201-8300
Novartis Investigative Site Recruiting
Marietta, Georgia, United States, 30060
United States, Illinois
Novartis Investigative Site Recruiting
Evanston, Illinois, United States, 60201
Novartis Investigative Site Recruiting
Peoria, Illinois, United States, 61615
Novartis Investigative Site Terminated
Quincy, Illinois, United States, 62301
Novartis Investigative Site Recruiting
Skokie, Illinois, United States, 60076
Novartis Investigative Site Not yet recruiting
Skokie, Illinois, United States, 60076
United States, Indiana
Novartis Investigative Site Terminated
Anderson, Indiana, United States, 46016
Novartis Investigative Site Completed
Indianapolis, Indiana, United States, 46237
United States, Iowa
Novartis Investigative Site Recruiting
Ames, Iowa, United States, 50010
United States, Kentucky
Novartis Investigative Site Terminated
Mount Sterling, Kentucky, United States, 40353
United States, Louisiana
Novartis Investigative Site Terminated
Metairie, Louisiana, United States, 70006
Novartis Investigative Site Recruiting
Shreveport, Louisiana, United States, 71103
United States, Maine
Novartis Investigative Site Terminated
Waterville, Maine, United States, 04901
United States, Maryland
Novartis Investigative Site Terminated
Silver Spring, Maryland, United States, 20910
United States, Michigan
Novartis Investigative Site Recruiting
Grand Rapids, Michigan, United States, 49503
Novartis Investigative Site Terminated
Kalamazoo, Michigan, United States, 49007
United States, Mississippi
Novartis Investigative Site Terminated
Jackson, Mississippi, United States, 39202
United States, Missouri
Novartis Investigative Site Completed
Columbia, Missouri, United States, 65201
Novartis Investigative Site Recruiting
Kansas City, Missouri, United States, 64111
Novartis Investigative Site Recruiting
Springfield, Missouri, United States, 65807
Novartis Investigative Site Terminated
St. Joseph, Missouri, United States, 64507
United States, Montana
Novartis Investigative Site Not yet recruiting
Bozeman, Montana, United States, 59715
United States, Nebraska
Novartis Investigative Site Recruiting
Lincoln, Nebraska, United States, 68506
Novartis Investigative Site Recruiting
Lincoln, Nebraska, United States, 68510
United States, New Mexico
Novartis Investigative Site Terminated
Albuquerque, New Mexico, United States, 87131
Novartis Investigative Site Terminated
Albuquerque, New Mexico, United States, 87110
United States, New York
Novartis Investigative Site Recruiting
Lake Success, New York, United States, 10042
Novartis Investigative Site Recruiting
Mount Kisco, New York, United States, 10549
United States, North Carolina
Novartis Investigative Site Recruiting
Greensboro, North Carolina, United States, 27403
United States, North Dakota
Novartis Investigative Site Terminated
Bismarck, North Dakota, United States, 58501
United States, Ohio
Novartis Investigative Site Recruiting
Canton, Ohio, United States, 44708
Novartis Investigative Site Terminated
Canton, Ohio, United States, 44708
United States, Oregon
Novartis Investigative Site Terminated
Portland, Oregon, United States, 97213
United States, Pennsylvania
Novartis Investigative Site Recruiting
Danville, Pennsylvania, United States, 17822
Novartis Investigative Site Terminated
Ephrata, Pennsylvania, United States, 17522
Novartis Investigative Site Terminated
Lancaster, Pennsylvania, United States, 17605
Novartis Investigative Site Recruiting
Willow Grove, Pennsylvania, United States, 19090
United States, Tennessee
Novartis Investigative Site Terminated
Chattanooga, Tennessee, United States, 37404
Novartis Investigative Site Terminated
Germantown, Tennessee, United States, 38138
Novartis Investigative Site Not yet recruiting
Knoxville, Tennessee, United States, 37916
United States, Texas
Novartis Investigative Site Recruiting
Fort Sam Houston, Texas, United States, 78234
Novartis Investigative Site Terminated
Houston, Texas, United States, 77030
United States, Utah
Novartis Investigative Site Not yet recruiting
Ogden, Utah, United States, 84403
Novartis Investigative Site Recruiting
Salt Lake City, Utah, United States, 84106
United States, Virginia
Novartis Investigative Site Recruiting
Fredericksburg, Virginia, United States, 22408
United States, Washington
Novartis Investigative Site Recruiting
Kennewick, Washington, United States, 99336
Novartis Investigative Site Not yet recruiting
Kirkland, Washington, United States, 98034
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Mount Vernon, Washington, United States, 98273
Novartis Investigative Site Not yet recruiting
Seattle, Washington, United States, 98112
Novartis Investigative Site Recruiting
Seattle, Washington, United States, 98109
Novartis Investigative Site Not yet recruiting
Sequim, Washington, United States, 98382
Novartis Investigative Site Recruiting
Spokane, Washington, United States, 99208
Belgium
Novartis Investigative Site Recruiting
Antwerpen, Belgium, 2020
Novartis Investigative Site Recruiting
Antwerpen, Belgium, 2060
Novartis Investigative Site Recruiting
Brugge, Belgium, 8000
Novartis Investigative Site Terminated
Brussels, Belgium, 1090
Novartis Investigative Site Recruiting
Bruxelles, Belgium, 1000
Novartis Investigative Site Recruiting
Kortrijk, Belgium, 8500
Novartis Investigative Site Recruiting
Leuven, Belgium, 3000
Novartis Investigative Site Recruiting
Wilrijk, Belgium, 2610
Brazil
Novartis Investigative Site Not yet recruiting
Salvador, Bahía, Brazil, 41253-190
Novartis Investigative Site Not yet recruiting
Betim, Minas Gerais, Brazil, 32.651-760
Novartis Investigative Site Recruiting
Curitiba, Paraná, Brazil, 80060-900
Novartis Investigative Site Recruiting
Porto Alegre, Rio Grande Do Sul, Brazil, 90470-340
Novartis Investigative Site Terminated
Barretos, São Paulo, Brazil, 14784-400
Novartis Investigative Site Recruiting
Jau, São Paulo, Brazil, 17210-080
Novartis Investigative Site Not yet recruiting
Sao Paulo, São Paulo, Brazil, 04039-901
Novartis Investigative Site Recruiting
Rio de Janeiro, Brazil, 20230 -130
Novartis Investigative Site Recruiting
Rio de Janeiro, Brazil, 22793-080
Novartis Investigative Site Recruiting
São Paulo, Brazil, 05403-000
Novartis Investigative Site Terminated
São Paulo, Brazil, 01308-000
Novartis Investigative Site Recruiting
São Paulo, Brazil, 01223-001
Bulgaria
Novartis Investigative Site Terminated
Pleven, Bulgaria, 5800
Novartis Investigative Site Recruiting
Plovdiv, Bulgaria, 4000
Novartis Investigative Site Recruiting
Sofia, Bulgaria
Novartis Investigative Site Completed
Sofia, Bulgaria, 1431
Novartis Investigative Site Terminated
Sofia, Bulgaria, 1233
Novartis Investigative Site Recruiting
Varna, Bulgaria, 9010
Canada, New Brunswick
Novartis Investigative Site Recruiting
Moncton, New Brunswick, Canada, E1C 6Z8
Canada, Ontario
Novartis Investigative Site Recruiting
Kitchener, Ontario, Canada, N2G 1G3
Canada, Quebec
Novartis Investigative Site Recruiting
Québec, Quebec, Canada, G1J 1Z4
Novartis Investigative Site Terminated
Sherbrooke, Quebec, Canada, J1H 5N4
China, Guangdong
Novartis Investigative Site Recruiting
Guangzhou, Guangdong, China, 510060
Novartis Investigative Site Not yet recruiting
Guangzhou, Guangdong, China, 510080
China, Zhejiang
Novartis Investigative Site Recruiting
Hangzhou, Zhejiang, China, 310003
China
Novartis Investigative Site Recruiting
Beijing, China, 100021
Novartis Investigative Site Recruiting
Beijing, China, 100730
Novartis Investigative Site Recruiting
Beijing, China, 100071
Novartis Investigative Site Recruiting
Beijing, China, 100142
Novartis Investigative Site Recruiting
Beijing, China, 100044
Novartis Investigative Site Recruiting
Shanghai, China, 200025
Novartis Investigative Site Recruiting
Shanghai, China, 200032
Novartis Investigative Site Terminated
Tianjin, China, 300020
Czech Republic
Novartis Investigative Site Recruiting
Brno, Czech Republic, 625 00
Novartis Investigative Site Recruiting
Hradec Kralove, Czech Republic
Novartis Investigative Site Not yet recruiting
Ostrava, Czech Republic, 708 52
Novartis Investigative Site Recruiting
Praha 2, Czech Republic, 128 08
France
Novartis Investigative Site Recruiting
Boulogne sur Mer Cedex, France, 62321
Novartis Investigative Site Recruiting
Clermont-Ferrand Cedex 1, France, 63003
Novartis Investigative Site Recruiting
La Roche sur Yon Cedex 9, France, 85925
Novartis Investigative Site Recruiting
Le Mans, France, 72015
Novartis Investigative Site Recruiting
Montpellier cedex 5, France, 34295
Novartis Investigative Site Recruiting
Pessac cedex, France, 33604
Hungary
Novartis Investigative Site Recruiting
Budapest, Hungary, 1122
Novartis Investigative Site Recruiting
Debrecen, Hungary, 4012
Novartis Investigative Site Recruiting
Győr, Hungary, 9023
Novartis Investigative Site Recruiting
Szeged, Hungary, 6720
Japan
Novartis Investigative Site Recruiting
Aichi, Japan, 466-8650
Novartis Investigative Site Recruiting
Kyoto, Japan, 602-8566
Novartis Investigative Site Recruiting
Miyagi, Japan, 980-8574
Novartis Investigative Site Recruiting
Nagasaki, Japan, 852-8501
Novartis Investigative Site Recruiting
Saitama, Japan, 350-8550
Novartis Investigative Site Recruiting
Tochigi, Japan, 329-0498
Novartis Investigative Site Recruiting
Tokyo, Japan, 104-0045
Novartis Investigative Site Recruiting
Tokyo, Japan, 135-8550
Korea, Republic of
Novartis Investigative Site Recruiting
Busan, Korea, Republic of, 602-715
Novartis Investigative Site Recruiting
Seoul, Korea, Republic of, 135-710
Novartis Investigative Site Completed
Seoul, Korea, Republic of, 120-752
Peru
Novartis Investigative Site Recruiting
Miraflores, Lima, Peru, Lima 18
Novartis Investigative Site Completed
San Isidro, Lima, Peru, Lima 27
Novartis Investigative Site Recruiting
Lima, Peru, Lima 11
Novartis Investigative Site Completed
Lima, Peru, Lima 34
Novartis Investigative Site Recruiting
Lima, Peru, Lima 41
Puerto Rico
Novartis Investigative Site Recruiting
San Juan, Puerto Rico, 00918
Slovakia
Novartis Investigative Site Recruiting
Bratislava, Slovakia, 833 10
Novartis Investigative Site Completed
Kosice, Slovakia, 041 66
Novartis Investigative Site Terminated
Martin, Slovakia, 036 59
South Africa
Novartis Investigative Site Recruiting
Parktown, Gauteng, South Africa, 2193
Novartis Investigative Site Recruiting
Athlone Park, Amanzimtoti, South Africa, 4126
Novartis Investigative Site Recruiting
Port Elizabeth, South Africa, 6045
Novartis Investigative Site Recruiting
Saxonwold, Johannesburg, South Africa, 2196
Ukraine
Novartis Investigative Site Terminated
Donetsk, Ukraine, 83045
Novartis Investigative Site Recruiting
Kyiv, Ukraine, 03022
Novartis Investigative Site Completed
Kyiv, Ukraine, 03115
Novartis Investigative Site Recruiting
Lviv, Ukraine, 79044
Novartis Investigative Site Completed
Makiivka, Ukraine, 86132
Novartis Investigative Site Completed
Simferopil, Ukraine, 95023
Sponsors and Collaborators
Novartis
GlaxoSmithKline
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT01200589     History of Changes
Other Study ID Numbers: 113676 
Study First Received: September 10, 2010
Last Updated: March 22, 2016
Health Authority: Slovakia: State Institute for Drug Control
France: Conseil National de l'Ordre des Médecins
Bulgaria: The Bulgarian Drug Agency
Peru: Ministry of Health
Hungary: National Institute of Pharmacy
South Africa: Medicines Control Council
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Japan: Pharmaceutical and Medical Device Agency
Canada: Biologics and Genetic Therapies Directorate (BGTD)
Brazil: ANVISA
Ukraine: State Pharmacological Center of Ministry of Health of Ukraine
China: Food and Drug Administration
South Korea: Food and Drug Administration
United States: Food and Drug Administration
Czech Republic: State Institute for Drug Control

Keywords provided by Novartis:
Randomized trial
Ofatumumab
Rituximab
Indolent B-Cell Non Hodgkin Lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on July 26, 2016