AzTrials
AzTrials

Non-Hodgkin's LymphomaPhase 3HOMERNCT01200589

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

A Phase 3 study testing Ofatumumab and Rituximab in people with Non-Hodgkin's Lymphoma, run by Novartis Pharmaceuticals at 155 sites in 16 countries.

Terminated

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

Official record
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Trial summary

This was 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Hodgkin's Lymphoma
What is being tested?
Ofatumumab and Rituximab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
438 participants
Where
155 sitesin 16 countries
Study dates
11 Oct 2010to 19 Dec 2016
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Indolent NHL subtypes defined according to World Health Organization guidelines:
  • Follicular lymphoma Grades 1, 2, 3 A
  • Small lymphocytic lymphoma (SLL)
  • Marginal zone lymphoma
  • Lymphoplasmacytic lymphoma
  • 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.
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  • Relapse or disease progression following response to prior rituximab-based therapy, as defined by 2007 RRCML criteria, which requires therapy.
  • 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.
  • ECOG Performance Status of 0, 1, or 2.
  • Age ≥18 years.
  • Life expectancy of at least 6 months in the opinion of the investigator.
  • The patient or their legally acceptable representative must be capable of giving written informed consent prior to performing any study-specific tests or procedures.
  • 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.
  • One or more of the following indications for treatment:
  • Cytopenias
  • 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
  • Progressive or massive lymphadenopathy OR
  • 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.

Who cannot join

  • Previous treatment with ofatumumab.
  • 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.
  • Previous autologous stem cell transplantation within 6 months prior to randomization.
  • Previous allogeneic stem cell transplantation.
  • 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.
  • 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.
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  • 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.
  • 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.
  • 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.
  • 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.
  • Screening laboratory values:
  • Neutrophils < 1.5 x 10^9/L (unless due to iNHL involvement of the bone marrow)
  • Platelets < 50 x 10^9/L (unless due to iNHL involvement of the bone marrow)
  • ALT or AST > 3 x ULN
  • Alkaline phosphatase > 1.5 x ULN (unless due to lymphoma or a non-malignant, non-hepatic cause such as Paget's disease)
  • Total bilirubin > 1.5 x ULN (unless due to lymphoma or isolated, predominantly indirect hyperbilirubinemia due to Gilbert's syndrome)
  • Known or suspected inability to fully comply with study protocol
  • Because the effects of ofatumumab on fetuses and nursing infants are not known, the following are ineligible for study entry:
  • Lactating women.
  • Women with a positive pregnancy test at study entry.
  • 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).
  • Current active liver or biliary disease (with the exception of Gilbert's syndrome or asymptomatic gallstones).
  • 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.

Trial locations and contacts

155 sites in 16 countries.

155 sites in 16 countries

United States70 sites

  • Novartis Investigative Site

    Albuquerque, New Mexico, 87110

  • Novartis Investigative Site

    Albuquerque, New Mexico, 87131

  • Novartis Investigative Site

    Ames, Iowa, 50010

  • Novartis Investigative Site

    Anchorage, Alaska, 99508

  • Novartis Investigative Site

    Anderson, Indiana, 46016

  • Novartis Investigative Site

    Bismarck, North Dakota, 58501

  • Novartis Investigative Site

    Bozeman, Montana, 59715

  • Novartis Investigative Site

    Canton, Ohio, 44708

  • Novartis Investigative Site

    Canton, Ohio, 44710

  • Novartis Investigative Site

    Chattanooga, Tennessee, 37404

  • Novartis Investigative Site

    Columbia, Missouri, 65201

  • Novartis Investigative Site

    Danville, Pennsylvania, 17822

  • Novartis Investigative Site

    Ephrata, Pennsylvania, 17522

  • Novartis Investigative Site

    Evanston, Illinois, 60201

  • Novartis Investigative Site

    Fort Sam Houston, Texas, 78234

  • Novartis Investigative Site

    Fredericksburg, Virginia, 22408

  • Novartis Investigative Site

    Germantown, Tennessee, 38138

  • Novartis Investigative Site

    Gilbert, Arizona, 85234

  • Novartis Investigative Site

    Grand Rapids, Michigan, 49503

  • Novartis Investigative Site

    Greenbrae, California, 94904

  • Novartis Investigative Site

    Greensboro, North Carolina, 27403

  • Novartis Investigative Site

    Hot Springs, Arkansas, 71913

  • Novartis Investigative Site

    Houston, Texas, 77030

  • Novartis Investigative Site

    Indianapolis, Indiana, 46237

  • Novartis Investigative Site

    Jackson, Mississippi, 39202

  • Novartis Investigative Site

    Kalamazoo, Michigan, 49007

  • Novartis Investigative Site

    Kansas City, Missouri, 64111

  • Novartis Investigative Site

    Kennewick, Washington, 99336

  • Novartis Investigative Site

    Kirkland, Washington, 98034

  • Novartis Investigative Site

    Knoxville, Tennessee, 37916

  • Novartis Investigative Site

    Lake Success, New York, 10042

  • Novartis Investigative Site

    Lakeland, Florida, 33805

  • Novartis Investigative Site

    Lancaster, Pennsylvania, 17605

  • Novartis Investigative Site

    Lincoln, Nebraska, 68506

  • Novartis Investigative Site

    Lincoln, Nebraska, 68510

  • Novartis Investigative Site

    Macon, Georgia, 31201-8300

  • Novartis Investigative Site

    Marietta, Georgia, 30060

  • Novartis Investigative Site

    Metairie, Louisiana, 70006

  • Novartis Investigative Site

    Monterey, California, 93940

  • Novartis Investigative Site

    Mount Kisco, New York, 10549

  • Novartis Investigative Site

    Mount Sterling, Kentucky, 40353

  • Novartis Investigative Site

    Mount Vernon, Washington, 98273

  • Novartis Investigative Site

    New Milford, Connecticut, 06776

  • Novartis Investigative Site

    Ogden, Utah, 84403

  • Novartis Investigative Site

    Orlando, Florida, 32806

  • Novartis Investigative Site

    Pembroke Pines, Florida, 33028

  • Novartis Investigative Site

    Peoria, Illinois, 61615

  • Novartis Investigative Site

    Pleasant Hill, California, 94523

  • Novartis Investigative Site

    Port Saint Lucie, Florida, 34952

  • Novartis Investigative Site

    Portland, Oregon, 97213

  • Novartis Investigative Site

    Quincy, Illinois, 62301

  • Novartis Investigative Site

    Rancho Mirage, California, 92270

  • Novartis Investigative Site

    Saint Joseph, Missouri, 64507

  • Novartis Investigative Site

    Salinas, California, 93901

  • Novartis Investigative Site

    Salt Lake City, Utah, 84106

  • Novartis Investigative Site

    San Diego, California, 92123

  • Novartis Investigative Site

    San Pablo, California, 94806

  • Novartis Investigative Site

    Santa Monica, California, 90403

  • Novartis Investigative Site

    Seattle, Washington, 98109

  • Novartis Investigative Site

    Seattle, Washington, 98112

  • Novartis Investigative Site

    Sequim, Washington, 98382

  • Novartis Investigative Site

    Shreveport, Louisiana, 71103

  • Novartis Investigative Site

    Silver Spring, Maryland, 20910

  • Novartis Investigative Site

    Skokie, Illinois, 60076

  • Novartis Investigative Site

    Spokane, Washington, 99208

  • Novartis Investigative Site

    Springfield, Missouri, 65807

  • Novartis Investigative Site

    Torrington, Connecticut, 06790

  • Novartis Investigative Site

    Waterville, Maine, 04901

  • Novartis Investigative Site

    West Palm Beach, Florida, 33401

  • Novartis Investigative Site

    Willow Grove, Pennsylvania, 19090

Other trials in United States

Brazil12 sites

  • Novartis Investigative Site

    Barretos, São Paulo, 14784-400

  • Novartis Investigative Site

    Betim, Minas Gerais, 32.651-760

  • Novartis Investigative Site

    Curitiba, Paraná, 80060-900

  • Novartis Investigative Site

    Jaú, São Paulo, 17210-080

  • Novartis Investigative Site

    Porto Alegre, Rio Grande do Sul, 90470-340

  • Novartis Investigative Site

    Rio de Janeiro, 20230 -130

  • Novartis Investigative Site

    Rio de Janeiro, 22793-080

  • Novartis Investigative Site

    Salvador, Estado de Bahia, 41253-190

  • Novartis Investigative Site

    São Paulo, São Paulo, 01223-001

  • Novartis Investigative Site

    São Paulo, São Paulo, 01308-000

  • Novartis Investigative Site

    São Paulo, São Paulo, 04039-901

  • Novartis Investigative Site

    São Paulo, São Paulo, 05403-000

Other trials in Brazil

China11 sites

  • Novartis Investigative Site

    Beijing, 100021

  • Novartis Investigative Site

    Beijing, 100044

  • Novartis Investigative Site

    Beijing, 100071

  • Novartis Investigative Site

    Beijing, 100142

  • Novartis Investigative Site

    Beijing, 100730

  • Novartis Investigative Site

    Guangzhou, Guangdong, 510060

  • Novartis Investigative Site

    Guangzhou, Guangdong, 510080

  • Novartis Investigative Site

    Hangzhou, Zhejiang, 310003

  • Novartis Investigative Site

    Shanghai, 200025

  • Novartis Investigative Site

    Shanghai, 200032

  • Novartis Investigative Site

    Tianjin, 300020

Other trials in China

Belgium8 sites

  • Novartis Investigative Site

    Antwerp, 2020

  • Novartis Investigative Site

    Antwerp, 2060

  • Novartis Investigative Site

    Bruges, 8000

  • Novartis Investigative Site

    Brussels, 1000

  • Novartis Investigative Site

    Brussels, 1090

  • Novartis Investigative Site

    Kortrijk, 8500

  • Novartis Investigative Site

    Leuven, 3000

  • Novartis Investigative Site

    Wilrijk, 2610

Other trials in Belgium

Japan8 sites

  • Novartis Investigative Site

    Aichi, 466-8650

  • Novartis Investigative Site

    Kyoto, 602-8566

  • Novartis Investigative Site

    Miyagi, 980-8574

  • Novartis Investigative Site

    Nagasaki, 852-8501

  • Novartis Investigative Site

    Saitama, 350-8550

  • Novartis Investigative Site

    Tochigi, 329-0498

  • Novartis Investigative Site

    Tokyo, 104-0045

  • Novartis Investigative Site

    Tokyo, 135-8550

Other trials in Japan

Bulgaria6 sites

  • Novartis Investigative Site

    Pleven, 5800

  • Novartis Investigative Site

    Plovdiv, 4000

  • Novartis Investigative Site

    Sofia, 1233

  • Novartis Investigative Site

    Sofia, 1431

  • Novartis Investigative Site

    Sofia

  • Novartis Investigative Site

    Varna, 9010

Other trials in Bulgaria

France6 sites

  • Novartis Investigative Site

    Boulogne-sur-Mer, 62321

  • Novartis Investigative Site

    Clermont-Ferrand, 63003

  • Novartis Investigative Site

    La Roche-sur-Yon, 85925

  • Novartis Investigative Site

    Le Mans, 72015

  • Novartis Investigative Site

    Montpellier, 34295

  • Novartis Investigative Site

    Pessac, 33604

Other trials in France

Ukraine6 sites

  • Novartis Investigative Site

    Donetsk, 83045

  • Novartis Investigative Site

    Kyiv, 03022

  • Novartis Investigative Site

    Kyiv, 03115

  • Novartis Investigative Site

    Lviv, 79044

  • Novartis Investigative Site

    Makiivka, 86132

  • Novartis Investigative Site

    Simferopil, 95023

Other trials in Ukraine

Peru5 sites

  • Novartis Investigative Site

    Lima, Lima 11

  • Novartis Investigative Site

    Lima, Lima 34

  • Novartis Investigative Site

    Lima, Lima 41

  • Novartis Investigative Site

    Miraflores, Lima region, Lima 18

  • Novartis Investigative Site

    San Isidro, Lima region, Lima 27

Other trials in Peru

Canada4 sites

  • Novartis Investigative Site

    Kitchener, Ontario, N2G 1G3

  • Novartis Investigative Site

    Moncton, New Brunswick, E1C 6Z8

  • Novartis Investigative Site

    Québec, Quebec, G1J 1Z4

  • Novartis Investigative Site

    Sherbrooke, Quebec, J1H 5N4

Other trials in Canada

Czechia4 sites

  • Novartis Investigative Site

    Brno, 625 00

  • Novartis Investigative Site

    Hradec Králové

  • Novartis Investigative Site

    Ostrava, 708 52

  • Novartis Investigative Site

    Prague, 128 08

Other trials in Czechia

Hungary4 sites

  • Novartis Investigative Site

    Budapest, 1122

  • Novartis Investigative Site

    Debrecen, 4012

  • Novartis Investigative Site

    Győr, 9023

  • Novartis Investigative Site

    Szeged, 6720

Other trials in Hungary

South Africa4 sites

  • Novartis Investigative Site

    Athlone Park, Amanzimtoti, 4126

  • Novartis Investigative Site

    Parktown, Gauteng, 2193

  • Novartis Investigative Site

    Port Elizabeth, 6045

  • Novartis Investigative Site

    Saxonwold, Johannesburg, 2196

Other trials in South Africa

Slovakia3 sites

  • Novartis Investigative Site

    Bratislava, 833 10

  • Novartis Investigative Site

    Košice, 041 66

  • Novartis Investigative Site

    Martin, 036 59

Other trials in Slovakia

South Korea3 sites

  • Novartis Investigative Site

    Busan, 602-715

  • Novartis Investigative Site

    Seoul, 120-752

  • Novartis Investigative Site

    Seoul, 135-710

Other trials in South Korea

Puerto Rico1 site

  • Novartis Investigative Site

    San Juan, 00918

Other trials in Puerto Rico

About this study

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

This was 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 were to 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 were to receive a total of eight doses of anti-CD20 antibody over 9 months. Subjects were evaluated for response after completion of the first four doses of therapy, after six doses of therapy, and after completion of study therapy. Subjects were to be followed until the end of the designated follow-up period (total study duration of 200 weeks) or until they meet the withdrawal criteria.

The primary objective of the study OMB157D 2303 was to demonstrate the efficacy of Arzerra based on the primary endpoint (Progression-free survival (PFS) as assessed by the IRC) in patients with Indolent B-cell Non-Hodgkin's Lymphoma Relapsed After Rituximab-Containing Regimen.

Read more

The Independent Data Monitoring Committee (IDMC) met on November 22, 2015 and recommended the termination of the study due to futility (cut-off date = 12Jun2015). The IDMC reviewed analyses results for progression free survival (PFS), overall response rate (ORR), and overall survival (OS). Novartis accepted this recommendation and the study was closed.

Final analysis was performed (cut-off date =19 Dec 2016). As the study was stopped for futility, the primary objective was not met and some secondary endpoints, supportive of primary objective (Duration of Response (DOR), time to next therapy, and pharmacokinetics) were removed as secondary end points.

Being tested
Ofatumumab, Rituximab
Keywords
Randomized trial, Ofatumumab, Rituximab, Indolent B-Cell Non Hodgkin Lymphoma
Medical subject headings
Lymphoma, Non-Hodgkin

What participants receive

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

  • OfatumumabBiological

    Also called Arzerra

    liquid concentrate for solution for infusion in glass vials containing 50 mL of solution at a concentration of 20mg/ml to provide 1000 mg per vial.

  • RituximabBiological

    Also called Mabthera, Rituxan

    sourced locally from commercial stock

  • OfatumumabBiological

    Also called Arzerra

    Four weekly doses of single agent ofatumumab (1000 mg), followed by ofatumumab (1000 mg) every two months for four additional doses.

  • RituximabBiological

    Also called Mabthera, Rituxan

    Four weekly doses of single agent rituximab (375 mg/m2), followed by rituximab (375 mg/m2) every two months for four additional doses.

Study groups in NCT01200589
Study groupRoleWhat they receive
Arm A: OfatumumabExperimentalFour weekly doses of single agent ofatumumab (1000 mg), followed by ofatumumab (1000 mg) every two months for four additional doses.
Receives: Biological: Ofatumumab
Arm B: RituximabActive comparatorFour weekly doses of single agent rituximab (375 mg/m2), followed by rituximab (375 mg/m2) every two months for four additional doses.
Receives: Biological: Rituximab

What is being measured

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

  1. Progression-free Survival (PFS) - Number of Participants With PFS Events

    Disease response assessed by modified 2007 Revised Response Criteria for Malignant Lymphoma. Nodal disease, PD: 1)prev. normal node (<=1.5cm x <=1.0cm) that incr. to >2.0 x ≥1.5cm; 2)≥50% incr. from nadir product of perpendicular diameter (PPD) of any prev. involved node with long axis >1.5cm at baseline (BL) (must incr. by ≥0.5mm \& to >2.0cm) OR ≥50% incr. from nadir in long axis of any prev. inv. node with long axis of >1.5cm at BL (long axis must incr. by ≥0.5mm \& to >2.0cm); or 3)≥50% incr. from nadir in the sums of prod. of diameters (SPD) of target nodes \& ≥1 node with long axis >1.5cm. Extranodal, PD 1)any new lesion >2.0 x ≥1.5cm not attributed to non-lymphoma causes; 2)≥50% incr. from nadir PPD of any targ. les. \& >5mm incr. in either axis \& les. must measure >1.5cm x ≥1.5cm OR ≥50% incr. from nadir in long axis of any targ. les. \& >5mm incr. in either axis \& les. must measure >1.5cm x ≥1.5cm; or 3)≥50% incr. from nadir in SPD of targ. nodes \& ≥1 node with long axis >1.5cm.

    Measured: 200 weeks

Secondary outcomes (9)

  1. Number of Participants With Complete Response (CR)

    Complete response was assessed according to modified 2007 Revised Response Criteria for Malignant Lymphoma (RRCML) and defined as follows: 1) complete disappearance of all detectable clinical evidence of disease (all target nodes regressing to <=1.5cm in the long axis and all non-target lesions being normal in size by imaging) and disease-related symptoms if present before therapy; 2) the spleen/liver, if considered enlarged due to lymphoma based on CT scan prior to therapy, would be normal and nodules should disappear; and 3) if bone marrow was involved before treatment, the infiltrate must clear on repeat bone marrow biopsy. Computed tomography (CT) scans of the neck, thorax, abdomen and pelvis were performed as part of the efficacy evaluation.

    Measured: 200 weeks

  2. Number of Participants With Overall Response (OR)

    The overall response rate (ORR) was defined as the number of participants achieving a CR or partial response (PR). from start of randomization until disease progression, or the start of a new anti-cancer therapy. Disease response was assessed according to modified 2007 Revised Response Criteria for Malignant Lymphoma (RRCML). Computed tomography (CT) scans of the neck, thorax, abdomen and pelvis were performed as part of the efficacy evaluation. Bone marrow examination to confirm a suspected complete response (CR) was performed within 8 weeks following the onset of a CT scan confirmed CR.

    Measured: 200 weeks

  3. Number of Deaths

    The number of deaths were assessed.

    Measured: 200 weeks

  4. Number of Participants With Infection Related Adverse Events

    The number of participants with infection related adverse events was assessed.

    Measured: 200 weeks

  5. Number of Participants With Infusion Related Adverse Events Due to Study Drug

    The number of participants with infusion related adverse events due to study drug was assessed.

    Measured: 36 weeks + 60 days

  6. Number of Participants With Myelosuppression Adverse Events

    The number of participants with myelosuppression adverse events was assessed.

    Measured: 200 weeks

  7. Duration of Response (DOR)

    Measured: 200 weeks

  8. Time to Next Treatment

    Measured: 200 weeks

  9. Pharmacokinetics

    Measured: 70 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2010 (estimated)
  2. Study start11 Oct 2010
  3. Primary completion19 Dec 2016
  4. Study completion19 Dec 2016

Why it stopped: The study stopped due to futility.

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
Masking
None (open label)
Enrolment
438 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01200589
Sponsor's protocol ID
113676
Acronym
HOMER
Status last verified
Apr 2018
First submitted
10 Sep 2010
Last updated
16 May 2018
Data monitoring committee
Yes

Publications

  • Maloney DG, Ogura M, Fukuhara N, Davis J, Lasher J, Izquierdo M, Banerjee H, Tobinai K. A phase 3 randomized study (HOMER) of ofatumumab vs rituximab in iNHL relapsed after rituximab-containing therapy. Blood Adv. 2020 Aug 25;4(16):3886-3893. doi: 10.1182/bloodadvances.2020001942.

    PubMed 32810220

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ofatumumab and Rituximab in people with Non-Hodgkin's Lymphoma, run by Novartis Pharmaceuticals at 155 sites in 16 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 22 inclusion and 23 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 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 155 sites in United States, Brazil, China, Belgium, Japan and 11 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 May 2018). 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?

Progression-free Survival (PFS) - Number of Participants With PFS Events (time frame: 200 weeks). 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 NCT01200589, which also lists 1 linked publication.

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 May 2018.

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