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TerminatedNCT01200589HOMERUpdated May 16, 2018Results posted

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

A Phase 3 interventional study of Ofatumumab and Rituximab in Non-Hodgkin's Lymphoma, sponsored by Novartis Pharmaceuticals. Terminated at 155 sites in 16 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-05-16.

Sponsored by Novartis Pharmaceuticals · Phase 3, Interventional, and Treatment

Why this study was terminated
The study stopped due to futility.
Phase
Phase 3
Study type
Interventional
Enrollment
438
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

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.

02

Conditions studied

  • Non-Hodgkin's Lymphoma

Keywords

  • Randomized trial
  • Ofatumumab
  • Rituximab
  • Indolent B-Cell Non Hodgkin Lymphoma
03

In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's enrollment of 438 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.

Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Masking
None (open label)
Enrollment
438 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • BiologicalOfatumumab

    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.

    Also known as: Arzerra

  • BiologicalRituximab

    sourced locally from commercial stock

    Also known as: Mabthera, Rituxan

  • BiologicalOfatumumab

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

    Also known as: Arzerra

  • BiologicalRituximab

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

    Also known as: Mabthera, Rituxan

06

What researchers measure

Primary outcomes

  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.

    Time frame: 200 weeks

Secondary outcomes

  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.

    Time frame: 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.

    Time frame: 200 weeks

  3. Number of Deaths

    The number of deaths were assessed.

    Time frame: 200 weeks

  4. Number of Participants With Infection Related Adverse Events

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

    Time frame: 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.

    Time frame: 36 weeks + 60 days

  6. Number of Participants With Myelosuppression Adverse Events

    The number of participants with myelosuppression adverse events was assessed.

    Time frame: 200 weeks

  7. Duration of Response (DOR)

    Time frame: 200 weeks

  8. Time to Next Treatment

    Time frame: 200 weeks

  9. Pharmacokinetics

    Time frame: 70 weeks

07

Results

Posted May 16, 2018

Participant flow

Participant flow — Overall Study
MilestoneOfatumumabRituximab
Started219219
Intent-to-treat (itt) analysis set219219
Safety set217218
Completed2930
Not completed190189
Withdrew: Withdrawal by subject1311
Withdrew: Physician decision22
Withdrew: Lost to follow-up54
Withdrew: Study terminated170172

Outcome measures

PrimaryProgression-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.

Time frame:
200 weeks
Reported as:
Number · Participants
Progression-free Survival (PFS) - Number of Participants With PFS Events
ParticipantsOfatumumabRituximab
Progression-free Survival (PFS) - Number of Participants With PFS Events114117
Statistical analysis
  • Ofatumumab vs Rituximab · Hazard ratio (hr): 1.15 · 95% CI 0.89 to 1.49
SecondaryNumber 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.

Time frame:
200 weeks
Reported as:
Number · Participants
Number of Participants With Complete Response (CR)
ParticipantsOfatumumabRituximab
Number of Participants With Complete Response (CR)3644
SecondaryNumber 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.

Time frame:
200 weeks
Reported as:
Number · Participants
Number of Participants With Overall Response (OR)
ParticipantsOfatumumabRituximab
Number of Participants With Overall Response (OR)110144
SecondaryNumber of Deaths

The number of deaths were assessed.

Time frame:
200 weeks
Reported as:
Number · Participants
Number of Deaths
ParticipantsOfatumumabRituximab
Number of Deaths2830
SecondaryNumber of Participants With Infection Related Adverse Events

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

Time frame:
200 weeks
Reported as:
Number · Participants
Number of Participants With Infection Related Adverse Events
ParticipantsOfatumumabRituximab
Number of Participants With Infection Related Adverse Events6981
SecondaryNumber 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.

Time frame:
36 weeks + 60 days
Reported as:
Number · Participants
Number of Participants With Infusion Related Adverse Events Due to Study Drug
ParticipantsOfatumumabRituximab
Number of Participants With Infusion Related Adverse Events Due to Study Drug178112
SecondaryNumber of Participants With Myelosuppression Adverse Events

The number of participants with myelosuppression adverse events was assessed.

Time frame:
200 weeks
Reported as:
Number · Participants
Number of Participants With Myelosuppression Adverse Events
ParticipantsOfatumumabRituximab
Number of Participants With Myelosuppression Adverse Events2441
SecondaryDuration of Response (DOR)
Time frame:
200 weeks

No measurements were reported for this outcome.

SecondaryTime to Next Treatment
Time frame:
200 weeks

No measurements were reported for this outcome.

SecondaryPharmacokinetics
Time frame:
70 weeks

No measurements were reported for this outcome.

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Ofatumumab—38/217 (17.5%)177/217 (81.6%)
Rituximab—37/218 (17%)150/218 (68.8%)
Most frequent serious events
Showing 10 of 90
Most frequent serious events
EventOfatumumabRituximab
Infusion related reactionInjury, poisoning and procedural complications5/2170/218
PneumoniaInfections and infestations2/2175/218
SepsisInfections and infestations1/2173/218
NeutropeniaBlood and lymphatic system disorders2/2171/218
Squamous cell carcinoma of skinNeoplasms benign, malignant and unspecified (incl cysts and polyps)2/2170/218
Atrial fibrillationCardiac disorders1/2172/218
Intestinal obstructionGastrointestinal disorders0/2172/218
PyrexiaGeneral disorders0/2172/218
CoughRespiratory, thoracic and mediastinal disorders0/2172/218
DyspnoeaRespiratory, thoracic and mediastinal disorders0/2172/218
Most frequent other events
Showing 10 of 26
Most frequent other events
EventOfatumumabRituximab
RashSkin and subcutaneous tissue disorders42/21711/218
UrticariaSkin and subcutaneous tissue disorders41/2173/218
Infusion related reactionInjury, poisoning and procedural complications40/21719/218
FatigueGeneral disorders21/21728/218
White blood cell count decreasedInvestigations12/21723/218
NasopharyngitisInfections and infestations14/21722/218
PyrexiaGeneral disorders9/21721/218
DiarrhoeaGastrointestinal disorders20/21715/218
PruritusSkin and subcutaneous tissue disorders20/21714/218
HeadacheNervous system disorders11/21720/218

Baseline characteristics

Age, Continuous
Age, Continuous(Years)OfatumumabRituximabTotal
Mean60.8 ± 11.2760.7 ± 11.8460.8 ± 11.54
Sex: Female, Male
Sex: Female, Male(Participants)OfatumumabRituximabTotal
Female115109224
Male104110214
08

Study locations

155 sites
  • Novartis Investigative Site
    Anchorage, Alaska 99508, United States
  • Novartis Investigative Site
    Gilbert, Arizona 85234, United States
  • Novartis Investigative Site
    Hot Springs, Arkansas 71913, United States
  • Novartis Investigative Site
    Greenbrae, California 94904, United States
  • Novartis Investigative Site
    Monterey, California 93940, United States
  • Novartis Investigative Site
    Pleasant Hill, California 94523, United States
  • Novartis Investigative Site
    Rancho Mirage, California 92270, United States
  • Novartis Investigative Site
    Salinas, California 93901, United States
  • Novartis Investigative Site
    San Diego, California 92123, United States
  • Novartis Investigative Site
    San Pablo, California 94806, United States
  • Novartis Investigative Site
    Santa Monica, California 90403, United States
  • Novartis Investigative Site
    New Milford, Connecticut 06776, United States
  • Novartis Investigative Site
    Torrington, Connecticut 06790, United States
  • Novartis Investigative Site
    Lakeland, Florida 33805, United States
  • Novartis Investigative Site
    Orlando, Florida 32806, United States
  • Novartis Investigative Site
    Pembroke Pines, Florida 33028, United States
  • Novartis Investigative Site
    Port Saint Lucie, Florida 34952, United States
  • Novartis Investigative Site
    West Palm Beach, Florida 33401, United States
  • Novartis Investigative Site
    Macon, Georgia 31201-8300, United States
  • Novartis Investigative Site
    Marietta, Georgia 30060, United States
  • Novartis Investigative Site
    Evanston, Illinois 60201, United States
  • Novartis Investigative Site
    Peoria, Illinois 61615, United States
  • Novartis Investigative Site
    Quincy, Illinois 62301, United States
  • Novartis Investigative Site
    Skokie, Illinois 60076, United States
  • Novartis Investigative Site
    Anderson, Indiana 46016, United States
  • Novartis Investigative Site
    Indianapolis, Indiana 46237, United States
  • Novartis Investigative Site
    Ames, Iowa 50010, United States
  • Novartis Investigative Site
    Mount Sterling, Kentucky 40353, United States
  • Novartis Investigative Site
    Metairie, Louisiana 70006, United States
  • Novartis Investigative Site
    Shreveport, Louisiana 71103, United States
  • Novartis Investigative Site
    Waterville, Maine 04901, United States
  • Novartis Investigative Site
    Silver Spring, Maryland 20910, United States
  • Novartis Investigative Site
    Grand Rapids, Michigan 49503, United States
  • Novartis Investigative Site
    Kalamazoo, Michigan 49007, United States
  • Novartis Investigative Site
    Jackson, Mississippi 39202, United States
  • Novartis Investigative Site
    Columbia, Missouri 65201, United States
  • Novartis Investigative Site
    Kansas City, Missouri 64111, United States
  • Novartis Investigative Site
    Saint Joseph, Missouri 64507, United States
  • Novartis Investigative Site
    Springfield, Missouri 65807, United States
  • Novartis Investigative Site
    Bozeman, Montana 59715, United States
  • Novartis Investigative Site
    Lincoln, Nebraska 68506, United States
  • Novartis Investigative Site
    Lincoln, Nebraska 68510, United States
  • Novartis Investigative Site
    Albuquerque, New Mexico 87110, United States
  • Novartis Investigative Site
    Albuquerque, New Mexico 87131, United States
  • Novartis Investigative Site
    Lake Success, New York 10042, United States
  • Novartis Investigative Site
    Mount Kisco, New York 10549, United States
  • Novartis Investigative Site
    Greensboro, North Carolina 27403, United States
  • Novartis Investigative Site
    Bismarck, North Dakota 58501, United States
  • Novartis Investigative Site
    Canton, Ohio 44708, United States
  • Novartis Investigative Site
    Canton, Ohio 44710, United States
  • Novartis Investigative Site
    Portland, Oregon 97213, United States
  • Novartis Investigative Site
    Danville, Pennsylvania 17822, United States
  • Novartis Investigative Site
    Ephrata, Pennsylvania 17522, United States
  • Novartis Investigative Site
    Lancaster, Pennsylvania 17605, United States
  • Novartis Investigative Site
    Willow Grove, Pennsylvania 19090, United States
  • Novartis Investigative Site
    Chattanooga, Tennessee 37404, United States
  • Novartis Investigative Site
    Germantown, Tennessee 38138, United States
  • Novartis Investigative Site
    Knoxville, Tennessee 37916, United States
  • Novartis Investigative Site
    Fort Sam Houston, Texas 78234, United States
  • Novartis Investigative Site
    Houston, Texas 77030, United States
  • Novartis Investigative Site
    Ogden, Utah 84403, United States
  • Novartis Investigative Site
    Salt Lake City, Utah 84106, United States
  • Novartis Investigative Site
    Fredericksburg, Virginia 22408, United States
  • Novartis Investigative Site
    Kennewick, Washington 99336, United States
  • Novartis Investigative Site
    Kirkland, Washington 98034, United States
  • Novartis Investigative Site
    Mount Vernon, Washington 98273, United States
  • Novartis Investigative Site
    Seattle, Washington 98109, United States
  • Novartis Investigative Site
    Seattle, Washington 98112, United States
  • Novartis Investigative Site
    Sequim, Washington 98382, United States
  • Novartis Investigative Site
    Spokane, Washington 99208, United States
  • Novartis Investigative Site
    Antwerpen, 2020, Belgium
  • Novartis Investigative Site
    Antwerpen, 2060, Belgium
  • Novartis Investigative Site
    Brugge, 8000, Belgium
  • Novartis Investigative Site
    Brussels, 1090, Belgium
  • Novartis Investigative Site
    Bruxelles, 1000, Belgium
  • Novartis Investigative Site
    Kortrijk, 8500, Belgium
  • Novartis Investigative Site
    Leuven, 3000, Belgium
  • Novartis Investigative Site
    Wilrijk, 2610, Belgium
  • Novartis Investigative Site
    Salvador, Bahía 41253-190, Brazil
  • Novartis Investigative Site
    Betim, Minas Gerais 32.651-760, Brazil
  • Novartis Investigative Site
    Curitiba, Paraná 80060-900, Brazil
  • Novartis Investigative Site
    Porto Alegre, Rio Grande Do Sul 90470-340, Brazil
  • Novartis Investigative Site
    Barretos, São Paulo 14784-400, Brazil
  • Novartis Investigative Site
    Jau, São Paulo 17210-080, Brazil
  • Novartis Investigative Site
    Sao Paulo, São Paulo 01223-001, Brazil
  • Novartis Investigative Site
    Sao Paulo, São Paulo 01308-000, Brazil
  • Novartis Investigative Site
    Sao Paulo, São Paulo 04039-901, Brazil
  • Novartis Investigative Site
    Sao Paulo, São Paulo 05403-000, Brazil
  • Novartis Investigative Site
    Rio de Janeiro, 20230 -130, Brazil
  • Novartis Investigative Site
    Rio de Janeiro, 22793-080, Brazil
  • Novartis Investigative Site
    Pleven, 5800, Bulgaria
  • Novartis Investigative Site
    Plovdiv, 4000, Bulgaria
  • Novartis Investigative Site
    Sofia, 1233, Bulgaria
  • Novartis Investigative Site
    Sofia, 1431, Bulgaria
  • Novartis Investigative Site
    Sofia, Bulgaria
  • Novartis Investigative Site
    Varna, 9010, Bulgaria
  • Novartis Investigative Site
    Moncton, New Brunswick E1C 6Z8, Canada
  • Novartis Investigative Site
    Kitchener, Ontario N2G 1G3, Canada
  • Novartis Investigative Site
    Sherbrooke, Quebec J1H 5N4, Canada
  • Novartis Investigative Site
    Quebec, G1J 1Z4, Canada

Showing the first 100 of 155 sites across 16 countries.

09

References and documents

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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 16, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01200589
Lead sponsor
Novartis Pharmaceuticals
Collaborators
GlaxoSmithKline
Responsible party
Sponsor
First posted
Sep 13, 2010
Start date
Oct 11, 2010
Primary completion
Dec 19, 2016
Completion
Dec 19, 2016
Results posted
May 16, 2018
Last update
May 16, 2018

Study contacts

Novartis Pharmaceuticals
study director · Novartis Pharmaceuticals

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

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