NCT01313689 is a Phase 3 clinical trial of Ofatumumab in Leukaemia, sponsored by Novartis Pharmaceuticals.

Who is sponsoring NCT01313689?

NCT01313689 is sponsored by Novartis Pharmaceuticals.

What drugs are being tested in NCT01313689?

Interventions in NCT01313689: Ofatumumab, Physicians' Choice.

Is NCT01313689 still recruiting?

NCT01313689 is currently completed. Last updated 8 November 2018.

Are results published for NCT01313689?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2018-11-08 · How we verify

NCT01313689

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Ofatumumab vs Physician's Choice in Subjects With Bulky Fludarabine-Refractory Chronic Lymphocytic Leukemia

Completed Phase 3 Results posted Last updated 8 November 2018

What this trial tests

Phase 3 trial testing Ofatumumab in Leukaemia in 122 participants. Completed in 24 April 2017.

Timeline

14 April 2011

Primary endpoint
18 March 2014

24 April 2017

Quick facts

Lead sponsor	Novartis Pharmaceuticals
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	122
Start date	14 April 2011
Primary completion	18 March 2014
Estimated completion	24 April 2017
Sites	80 locations across France, Italy, Slovakia, Russia, Ukraine, Belgium, Austria, Sweden

Drugs / interventions tested

Ofatumumab (OFATUMUMAB) — full drug profile →
Physicians' Choice — full drug profile →

Conditions studied

Leukaemia — all drugs for Leukaemia →

Sponsor

Novartis Pharmaceuticals — full company profile →

Who can join

18 and older, any sex, with Leukaemia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Progression-free Survival (PFS) as Assessed by Independent Review Committee (IRC) Primary · From the randomization date up to 60 months post the randomization date.

PFS is the interval of time between the date of first randomization to the date of disease progression (PD) or death due to any reason, whichever occurred first. The date of PD was defined as the first occurrence of any criteria of progression. PD criteria requires at least one of the following: progression of lymphadenopathy, \>=50% increase in liver or spleen size, \>=50% increase in number of lymphocytes per microliter, more aggressive histology, occurence of cytopenia after treatment attributable to CLL. Disease progression was determined according to the 2008 International Workshop for Ch

Group	Value	95% CI
Any Ofatumumab (OFA)	5.36	4.30 – 6.97
Physician's Choice (PC)	3.61	1.87 – 6.74
Ofatumumab Extended (OFA Ext)	10.05	7.23 – 13.80
Ofatumumab Observation (OFA Observ.)	7.16	5.36 – 9.49

Progression-free Survival (PFS) as Assessed by Investigator Secondary · From the randomization date up to 60 months post the randomization date.

Group	Value	95% CI
Any Ofatumumab (OFA)	7.00	5.42 – 8.25
Physician's Choice (PC)	4.50	1.97 – 5.62
Ofatumumab Extended (OFA Ext)	12.68	10.09 – 14.29
Ofatumumab Observation (OFA Observ.)	9.49	7.00 – 12.12

Overall Response Rate (ORR) as Assessed by the IRC Secondary · From the randomization date up to 60 months post the randomization date.

ORR is defined as the number of participants achieving either complete response (CR) or partial response (PR). ORR was measured using the IWCLL updated NCI-WG guidelines 2008. CR requires all of the following criteria: no lymphadenopathy(Ly)/ hepatomegaly, splenomegaly, constitutional symptoms; neutrophils \>1500 per microliter(µL), platelets(PL) \>100,000/µL, hemoglobin(Hb) \>11 grams/deciliter(g/dL), lymphocytes(LC) \<4000/µL, bone marrow(BM) sample must be normocellular for age, \<30% LC and no lymphoid nodules. PR requires the following criteria for at least 2 months: \>=50% decrease in LC

Group	Value	95% CI
Any Ofatumumab (OFA)	0
Physician's Choice (PC)	0
Ofatumumab Extended (OFA Ext)	0
Ofatumumab Observation (OFA Observ.)	0

Group	Value	95% CI
Any Ofatumumab (OFA)	30
Physician's Choice (PC)	7
Ofatumumab Extended (OFA Ext)	18
Ofatumumab Observation (OFA Observ.)	8

nPR

Group	Value	95% CI
Any Ofatumumab (OFA)	0
Physician's Choice (PC)	0
Ofatumumab Extended (OFA Ext)	0
Ofatumumab Observation (OFA Observ.)	0

Stable Disease

Group	Value	95% CI
Any Ofatumumab (OFA)	36
Physician's Choice (PC)	22
Ofatumumab Extended (OFA Ext)	5
Ofatumumab Observation (OFA Observ.)	5

Progressive Disease

Group	Value	95% CI
Any Ofatumumab (OFA)	9
Physician's Choice (PC)	8
Ofatumumab Extended (OFA Ext)	1
Ofatumumab Observation (OFA Observ.)	0

Not Evaluable

Group	Value	95% CI
Any Ofatumumab (OFA)	4
Physician's Choice (PC)	6
Ofatumumab Extended (OFA Ext)	0
Ofatumumab Observation (OFA Observ.)	0

Missing

Group	Value	95% CI
Any Ofatumumab (OFA)	0
Physician's Choice (PC)	0
Ofatumumab Extended (OFA Ext)	0
Ofatumumab Observation (OFA Observ.)	0

Overall Response Rate (ORR) as Assessed by the Investigator Secondary · From the randomization date up to 60 months post the randomization date.

ORR is defined as the number of participants achieving either complete response (CR) or partial response (PR). Overall response was measured using the IWCLL updated NCI-WG guidelines 2008. CR requires all of the following criteria: no lymphadenopathy(Ly)/ hepatomegaly, splenomegaly, constitutional symptoms; neutrophils \>1500 per microliter(µL), platelets(PL) \>100,000/µL, hemoglobin(Hb) \>11 grams/deciliter(g/dL), lymphocytes(LC) \<4000/µL, bone marrow(BM) sample must be normocellular for age, \<30% LC and no lymphoid nodules. PR requires the following criteria for at least 2 months: \>=50% d

Group	Value	95% CI
Any Ofatumumab (OFA)	2
Physician's Choice (PC)	2
Ofatumumab Extended (OFA Ext)	1
Ofatumumab Observation (OFA Observ.)	1
OFA First Randomization Only (OFA FRO)	0

Group	Value	95% CI
Any Ofatumumab (OFA)	36
Physician's Choice (PC)	12
Ofatumumab Extended (OFA Ext)	17
Ofatumumab Observation (OFA Observ.)	7
OFA First Randomization Only (OFA FRO)	12

nPR

Group	Value	95% CI
Any Ofatumumab (OFA)	1
Physician's Choice (PC)	2
Ofatumumab Extended (OFA Ext)	0
Ofatumumab Observation (OFA Observ.)	1
OFA First Randomization Only (OFA FRO)	0

Stable Disease

Group	Value	95% CI
Any Ofatumumab (OFA)	34
Physician's Choice (PC)	14
Ofatumumab Extended (OFA Ext)	6
Ofatumumab Observation (OFA Observ.)	4
OFA First Randomization Only (OFA FRO)	24

Progressive Disease

Group	Value	95% CI
Any Ofatumumab (OFA)	2
Physician's Choice (PC)	10
Ofatumumab Extended (OFA Ext)	0
Ofatumumab Observation (OFA Observ.)	0
OFA First Randomization Only (OFA FRO)	2

Not Evaluable

Group	Value	95% CI
Any Ofatumumab (OFA)	0
Physician's Choice (PC)	0
Ofatumumab Extended (OFA Ext)	0
Ofatumumab Observation (OFA Observ.)	0
OFA First Randomization Only (OFA FRO)	0

Missing

Group	Value	95% CI
Any Ofatumumab (OFA)	4
Physician's Choice (PC)	3
Ofatumumab Extended (OFA Ext)	0
Ofatumumab Observation (OFA Observ.)	0
OFA First Randomization Only (OFA FRO)	4

Overall Survival Secondary · From the randomization date up to 60 months post the randomization date.

Overall survival (OS) is defined as the time from randomization to death due to any cause. Kaplan-Meier plots were used to estimate the reported median OS time.

Group	Value	95% CI
Any Ofatumumab (OFA)	19.19	12.19 – 29.11
Physician's Choice (PC)	14.52	8.94 – 24.97
Ofatumumab Extended (OFA Ext)	31.54	19.19 – 51.25
Ofatumumab Observation (OFA Observ.)	45.50	14.69 – NA
OFA First Randomization Only (OFA FRO)	8.57	4.93 – 16.76

Time to Progression as Assessed by IRC Secondary · From the randomization date up to 60 months post the randomization date.

Time to progression is defined as the time from the date of randomization to disease progression (PD). PD requires at least one of the following: lymphadenopathy, appearance of any new lesion such as enlarged lymph nodes (\>1.5 cm) spleen or liver or other infiltrates or an increase by 50% or more in the greatest diameter of any previous site; an increase by 50% or more in the previously noted enlargement of the liver or spleen, an increase by 50% or more in the numbers of blood lymphocytes with at least 5000 lymphocytes per microliter, transformation to a more aggressive histology, or occurre

Group	Value	95% CI
Any Ofatumumab (OFA)	6.31	4.83 – 7.33
Physician's Choice (PC)	5.32	2.14 – 8.08
Ofatumumab Extended (OFA Ext)	10.05	7.23 – 13.80
Ofatumumab Observation (OFA Observ.)	7.16	5.36 – 9.49

Time to Next Anti-cancer Therapy by Investigator Secondary · From the randomization date up to 60 months post the randomization date.

Time to next therapy is defined as the time from randomization until the start of the next line of treatment.

Group	Value	95% CI
Any Ofatumumab (OFA)	11.50	8.51 – 13.80
Physician's Choice (PC)	6.54	2.66 – 8.08
Ofatumumab Extended (OFA Ext)	15.47	11.86 – NA
Ofatumumab Observation (OFA Observ.)	9.00	8.08 – 14.16

Time to Response as Assessed by the IRC Secondary · From the randomization date up to 60 months post the randomization date.

Time to response is defined as the time from randomization to the first response (Complete Remission\[CR\], Complete Remission with incomplete bone marrow recovery\[CRi\], partial response\[PR\], or nodular PR\[nPR\]). CR(all the criteria at least 2 months after last treatment): no lymphadenopathy(Ly) \> 1.5 cm/ hepatomegaly/ splenomegaly/ constitutional symptoms; neutrophils \>1500 per microliter(µL), platelets(PL) \>100,000/µL, hemoglobin(Hb) \>11 grams/deciliter(g/dL), lymphocytes(LC) \<4000/µL, bone marrow(BM) sample must be normocellular for age, \<30% LC, no lymphoid nodule. CRi: CR crit

Group	Value	95% CI
Any Ofatumumab (OFA)	1.17	1.02 – 1.91
Physician's Choice (PC)	2.56	0.76 – 3.48
Ofatumumab Extended (OFA Ext)	1.86	1.05 – 1.94
Ofatumumab Observation (OFA Observ.)	1.15	0.92 – 1.94

Duration of Response as Assessed by the IRC Secondary · From the randomization date up to 60 months post the randomization date.

DOR is defined as the time from the initial response (CR, CRi, nPR, or PR) to the first documented sign of PD or death due to any cause. PD requires at least one of the following: lymphadenopathy, appearance of any new lesion such as enlarged lymph nodes (\>1.5 cm) spleen or liver or other infiltrates or an increase by 50% or more in the greatest diameter of any previous site; an increase by 50% or more in the previously noted enlargement of the liver or spleen, an increase by 50% or more in the numbers of blood lymphocytes with at least 5000 lymphocytes per microliter, transformation to a mor

Group	Value	95% CI
Any Ofatumumab (OFA)	6.24	5.32 – 12.22
Physician's Choice (PC)	6.95	4.47 – NA

Number of Participants With Any Adverse Event (AE), Any Serious Adverse Event (SAE), Any Fatal Serious Adverse Event (FSAE), or Deaths Secondary · From the first dose of study medication to 60 days after the last dose of study medication and until follow-up for SAEs unless initiation of subsequent anti-CLL therapy

An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. A SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, is a congenital anomaly or birth defect.

Any AE

Group	Value	95% CI
Any Ofatumumab (OFA)	71
Physician's Choice (PC)	37
Ofatumumab Extended (OFA Ext)	22
Ofatumumab Observation (OFA Observ.)	10
OFA First Randomization Only (OFA FRO)	39
OFA Salvage	20

Any SAE

Group	Value	95% CI
Any Ofatumumab (OFA)	43
Physician's Choice (PC)	23
Ofatumumab Extended (OFA Ext)	12
Ofatumumab Observation (OFA Observ.)	5
OFA First Randomization Only (OFA FRO)	26
OFA Salvage	10

Any FSAE

Group	Value	95% CI
Any Ofatumumab (OFA)	14
Physician's Choice (PC)	6
Ofatumumab Extended (OFA Ext)	2
Ofatumumab Observation (OFA Observ.)	3
OFA First Randomization Only (OFA FRO)	9
OFA Salvage	5

Deaths

Group	Value	95% CI
Any Ofatumumab (OFA)	1
Physician's Choice (PC)	0
Ofatumumab Extended (OFA Ext)	0
Ofatumumab Observation (OFA Observ.)	0
OFA First Randomization Only (OFA FRO)	1
OFA Salvage	0

Number of Participants With Any Adverse Event (AE) of Special Interest Secondary · From the first dose of study medication to 60 days after the last dose of study medication and until follow-up for SAEs unless initiation of subsequent anti-CLL therapy

AEs of special interest included cytopenias (neutropenia \[decreased neutrophil count\], anaemia \[decreased hemoglobin\], and thrombocytopenia \[decreased platelet count\]), autoimmune haematologic complications (autoimmune haemolytic anaemia and haemolytic anaemia), infusion reactions, infections, mucocutaneous reactions, Tumour Lysis Syndrome (TLS), cardiovascular events, and small bowel obstruction.

Any AE of decreased neutrophil count

Group	Value	95% CI
Any Ofatumumab (OFA)	23
Physician's Choice (PC)	15
Ofatumumab Extended (OFA Ext)	11
Ofatumumab Observation (OFA Observ.)	2

Any AE of decreased hemoglobin

Group	Value	95% CI
Any Ofatumumab (OFA)	9
Physician's Choice (PC)	9
Ofatumumab Extended (OFA Ext)	3
Ofatumumab Observation (OFA Observ.)	2

Any AE of decreased platelet count

Group	Value	95% CI
Any Ofatumumab (OFA)	10
Physician's Choice (PC)	5
Ofatumumab Extended (OFA Ext)	3
Ofatumumab Observation (OFA Observ.)	1

Any AE of autoimmune haemolytic anaemia

Group	Value	95% CI
Any Ofatumumab (OFA)	0
Physician's Choice (PC)	2
Ofatumumab Extended (OFA Ext)	0
Ofatumumab Observation (OFA Observ.)	0

Any AE of haemolytic anaemia

Group	Value	95% CI
Any Ofatumumab (OFA)	1
Physician's Choice (PC)	0
Ofatumumab Extended (OFA Ext)	1
Ofatumumab Observation (OFA Observ.)	0

Any infusion related AE

Group	Value	95% CI
Any Ofatumumab (OFA)	33
Physician's Choice (PC)	11
Ofatumumab Extended (OFA Ext)	8
Ofatumumab Observation (OFA Observ.)	4

Any AE of Infection

Group	Value	95% CI
Any Ofatumumab (OFA)	46
Physician's Choice (PC)	24
Ofatumumab Extended (OFA Ext)	16
Ofatumumab Observation (OFA Observ.)	8

Any AE of mucocutaneous reaction

Group	Value	95% CI
Any Ofatumumab (OFA)	20
Physician's Choice (PC)	4
Ofatumumab Extended (OFA Ext)	6
Ofatumumab Observation (OFA Observ.)	3

Mean Immunoglobulin (Ig) Antibodies IgA, IgG, and IgM Over Time Secondary · Screening and every 3 months during treatment, every 6 months after last treatment until PD or until 42 Month Follow-up Visit

Immunoglobulins or antibodies are large proteins used by the immune system to identify and neutralize foreign particles such as bacteria and viruses. Their normal blood levels indicate proper immune status. Low levels indicate immuno-suppression. IgA, IgG, and IgM were measured in the blood samples of the participants. Immunoglobulin testing was performed at Screening (SCR), Cycle 3 Week 4 (C3W4), Cycle 7 Week 4 (C3W4) ,Cycle 9 Week 4 (C3W4), 6 Month Follow-up Visit (6M FU), 9 Month Follow-up (9M FU), 12 Month Follow-up (12M FU), 18 Month Follow-up (18M FU), 24 Month Follow-up (24M FU), 30 Mon

IgA, SCR

Group	Value	95% CI
Any Ofatumumab (OFA)	0.793	± 0.6680
Physician's Choice (PC)	0.685	± 0.5518
Ofatumumab Extended (OFA Ext)	0.807	± 0.7426
Ofatumumab Observation (OFA Observ.)	1.095	± 0.7535
OFA First Randomization Only (OFA FRO)	0.688	± 0.5749

IgG, SCR

Group	Value	95% CI
Any Ofatumumab (OFA)	6.909	± 4.6836
Physician's Choice (PC)	8.615	± 12.1625
Ofatumumab Extended (OFA Ext)	6.270	± 3.8573
Ofatumumab Observation (OFA Observ.)	8.128	± 4.7569
OFA First Randomization Only (OFA FRO)	6.898	± 5.1142

IgM, SCR

Group	Value	95% CI
Any Ofatumumab (OFA)	0.800	± 1.3154
Physician's Choice (PC)	0.601	± 0.7061
Ofatumumab Extended (OFA Ext)	0.800	± 1.6649
Ofatumumab Observation (OFA Observ.)	0.468	± 0.3801
OFA First Randomization Only (OFA FRO)	0.907	± 1.2822

IgA, C3W4

Group	Value	95% CI
Any Ofatumumab (OFA)	0.721	± 0.6355
Physician's Choice (PC)	0.675	± 0.4819
Ofatumumab Extended (OFA Ext)	0.808	± 0.7931
Ofatumumab Observation (OFA Observ.)	0.977	± 0.6458
OFA First Randomization Only (OFA FRO)	0.514	± 0.3621
OFA Salvage	0.486	± 0.3868

IgG, C3W4

Group	Value	95% CI
Any Ofatumumab (OFA)	5.925	± 3.5059
Physician's Choice (PC)	5.481	± 2.1226
Ofatumumab Extended (OFA Ext)	5.949	± 3.4089
Ofatumumab Observation (OFA Observ.)	7.232	± 4.0103
OFA First Randomization Only (OFA FRO)	5.276	± 3.3056
OFA Salvage	5.974	± 2.7992

IgM, C3W4

Group	Value	95% CI
Any Ofatumumab (OFA)	0.692	± 1.3420
Physician's Choice (PC)	0.485	± 0.4929
Ofatumumab Extended (OFA Ext)	0.882	± 1.9833
Ofatumumab Observation (OFA Observ.)	0.429	± 0.3497
OFA First Randomization Only (OFA FRO)	0.636	± 0.7764
OFA Salvage	0.488	± 0.4816

IgA, C7W4

Group	Value	95% CI
Any Ofatumumab (OFA)	0.793	± 0.6608
Ofatumumab Extended (OFA Ext)	0.723	± 0.6730
Ofatumumab Observation (OFA Observ.)	0.945	± 0.6724
OFA First Randomization Only (OFA FRO)	0.725	± 0.6011
OFA Salvage	0.537	± 0.4356

IgG, C7W4

Group	Value	95% CI
Any Ofatumumab (OFA)	6.250	± 3.5225
Ofatumumab Extended (OFA Ext)	5.817	± 3.4944
Ofatumumab Observation (OFA Observ.)	7.254	± 3.7588
OFA First Randomization Only (OFA FRO)	5.420	± 2.2062
OFA Salvage	5.135	± 2.6309

Adverse events — posted to ClinicalTrials.gov

Time frame: SAEs & AEs were collected from first dose of study medication to 60 days after last dose of study medication & until end of the follow-up period (60 months post the randomization date) for SAEs unless initiation of subsequent anti-CLL therapy. AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Any Ofatumumab

Serious: 43/78 (55%)

Deaths: 16/78

Ofatumumab Extended

Serious: 12/24 (50%)

Deaths: 2/24

Ofatumumab Observation

Serious: 5/13 (38%)

Deaths: 3/13

Ofatumumab

Serious: 26/41 (63%)

Deaths: 11/41

Physicians Choice

Serious: 23/43 (53%)

Deaths: 8/43

Ofatumumab Salvage

Serious: 10/22 (45%)

Deaths: 5/22

Serious adverse events (92 terms)

Reaction	System	Any Ofatumumab	Ofatumumab Extended	Ofatumumab Observation	Ofatumumab	Physicians Choice	Ofatumumab Salvage
Pneumonia	Infections and infestations	—	—	—	—	—	—
Febrile neutropenia	Blood and lymphatic system disorders	—	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—
Sepsis	Infections and infestations	—	—	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—	—	—
Autoimmune haemolytic anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—
Atrial fibrillation	Cardiac disorders	—	—	—	—	—	—
Cardiac arrest	Cardiac disorders	—	—	—	—	—	—
Cardiac failure	Cardiac disorders	—	—	—	—	—	—
Cardiac failure acute	Cardiac disorders	—	—	—	—	—	—
Cellulitis	Infections and infestations	—	—	—	—	—	—
Meningitis	Infections and infestations	—	—	—	—	—	—
Neutropenic sepsis	Infections and infestations	—	—	—	—	—	—
Renal failure	Renal and urinary disorders	—	—	—	—	—	—
Pneumonitis	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—
Hypotension	Vascular disorders	—	—	—	—	—	—
Haemolytic anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—
Leukopenia	Blood and lymphatic system disorders	—	—	—	—	—	—
Neutropenia	Blood and lymphatic system disorders	—	—	—	—	—	—
Thrombocytopenia	Blood and lymphatic system disorders	—	—	—	—	—	—
Cardiovascular insufficiency	Cardiac disorders	—	—	—	—	—	—
Coronary artery insufficiency	Cardiac disorders	—	—	—	—	—	—
Myocardial infarction	Cardiac disorders	—	—	—	—	—	—
Supraventricular tachycardia	Cardiac disorders	—	—	—	—	—	—

Other adverse events (73 terms — click to expand)

Reaction	System	Any Ofatumumab	Ofatumumab Extended	Ofatumumab Observation	Ofatumumab	Physicians Choice	Ofatumumab Salvage
Neutropenia	Blood and lymphatic system disorders	—	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—
Chills	General disorders	—	—	—	—	—	—
Thrombocytopenia	Blood and lymphatic system disorders	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—
Bronchitis	Infections and infestations	—	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—	—	—	—	—
Hypertension	Vascular disorders	—	—	—	—	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—
Peripheral swelling	General disorders	—	—	—	—	—	—
Cytomegalovirus infection	Infections and infestations	—	—	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—	—	—
Sinusitis	Infections and infestations	—	—	—	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—	—	—	—
Hyperkalaemia	Metabolism and nutrition disorders	—	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—
Productive cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—
Cardiac failure	Cardiac disorders	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—
Asthenia	General disorders	—	—	—	—	—	—
Oedema peripheral	General disorders	—	—	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—	—	—
Contusion	Injury, poisoning and procedural complications	—	—	—	—	—	—
Aspartate aminotransferase increased	Investigations	—	—	—	—	—	—
Hypercalcaemia	Metabolism and nutrition disorders	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—
Paraesthesia	Nervous system disorders	—	—	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—
Dry skin	Skin and subcutaneous tissue disorders	—	—	—	—	—	—
Rash	Skin and subcutaneous tissue disorders	—	—	—	—	—	—
Urticaria	Skin and subcutaneous tissue disorders	—	—	—	—	—	—
Flushing	Vascular disorders	—	—	—	—	—	—
Leukopenia	Blood and lymphatic system disorders	—	—	—	—	—	—

Most-reported serious reactions: Pneumonia, Febrile neutropenia, Anaemia, Pyrexia, Sepsis, Upper respiratory tract infection, Autoimmune haemolytic anaemia, Atrial fibrillation.

Data from ClinicalTrials.gov NCT01313689 adverse events section.

Sponsor's own description

The purpose of this study was to confirm the clinical benefit observed in the pivotal registration study, Hx-CD20-406. The Committee for Medicinal Products for Human Use (CHMP) required that a randomized study be conducted in CLL patients with bulky fludarabine-refractory disease as a specific obligation for grant of conditional approval for ARZERRA™ in the European Union (EU). This study compared ofatumumab with the physicians' choice of therapy.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Characteristics and follow-up of postmarketing studies of conditionally authorized medicines in the EU.
Hoekman J, Klamer TT, Mantel-Teeuwisse AK, Leufkens HG, et al · · 2016 · cited 42× · PMID 26992001 · DOI 10.1111/bcp.12940
Phase III, randomized study of ofatumumab versus physicians' choice of therapy and standard versus extended-length ofatumumab in patients with bulky fludarabine-refractory chronic lymphocytic leukemia.
Österborg A, Udvardy M, Zaritskey A, Andersson PO, et al · · 2016 · cited 21× · PMID 26784000 · DOI 10.3109/10428194.2015.1122783
Ibrutinib: a paradigm shift in management of CLL.
Badar T, Burger JA, Wierda WG, O'Brien S. · · 2014 · cited 12× · PMID 25387837 · DOI 10.1586/17474086.2014.977862

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Trials testing the same drug.

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NCT06867991 — Safety and Efficacy of Combined B Cell Depleting theRapy And Daratumumab In Autoimmune Encephalitis · Phase 3 · recruiting
NCT06345157 — ITAKOS - Italian Observation, Multicenter, Prospective Study of Ofatumumab in RRMS Patients · active not recruiting
NCT07353216 — Exploring the Efficacy and Safety of Ofatumumab in Patients With Relapsing Multiple Sclerosis (RMS) and Its Impact on Se · recruiting
NCT05809986 — Ofatumumab in Portuguese Multiple Sclerosis Patients - an Observational Study · recruiting

Other recruiting trials for Leukaemia

Currently open trials in the same condition.

NCT07410676 — EBNK-001 Allogeneic NK Cells With Low-Dose IL-15 ± Pembrolizumab in Advanced Solid Tumors · Phase 1, PHASE2 · recruiting
NCT07167381 — xDRIVE for Florida-based Cancer Patients · NA · recruiting
NCT07305337 — Randomised Controlled Trial of Artificial Intelligence-assisted Health Education · NA · recruiting

Other Novartis Pharmaceuticals trials

Trials by the same sponsor.

NCT07498335 — Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary · Phase 3 · not yet recruiting
NCT07489573 — Study of Efficacy and Safety of Secukinumab in Chinese Adult Patients With Moderate to Severe Hidradenitis Suppurativa · Phase 4 · not yet recruiting
NCT07484269 — PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan · not yet recruiting
NCT07416162 — A Study of Iptacopan in Korean Patients With Paroxysmal Nocturnal Hemoglobinuria or C3 Glomerulopathy · not yet recruiting
NCT07387926 — Safety and Efficacy of Asciminib in Pediatrics and Young Adults With Relapse/Refractory (r/r) Philadelphia Positive (Ph+ · Phase 1, PHASE2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01313689 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novartis Pharmaceuticals
Last refreshed: 8 November 2018

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01313689.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing