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Monoclonal Antibodies

Ofatumumab for Chronic Lymphocytic Leukemia

Phase 2
Waitlist Available
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights

Study Summary

This trial will test if ofatumumab can help control untreated CLL/SLL, as well as study the drug's safety.

Eligible Conditions
  • Chronic Lymphocytic Leukemia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Patients with Complete Response (CR)

Side effects data

From 2021 Phase 3 trial • 319 Patients • NCT02004522
50%
Diarrhoea
34%
Neutropenia
29%
Pyrexia
25%
Anaemia
24%
Nausea
23%
Cough
17%
Thrombocytopenia
17%
Constipation
16%
Fatigue
16%
Pneumonia
15%
Vomiting
15%
Decreased appetite
14%
Upper respiratory tract infection
13%
Colitis
13%
Asthenia
13%
Weight decreased
13%
Bronchitis
11%
Abdominal pain
11%
Rash
10%
Hypokalaemia
10%
Oedema peripheral
9%
Aspartate aminotransferase increased
9%
Dyspnoea
8%
Alanine aminotransferase increased
8%
Back pain
8%
Dizziness
8%
Headache
8%
Hypertension
8%
Nasopharyngitis
7%
Pruritus
7%
Arthralgia
7%
Hyperkalaemia
7%
Respiratory tract infection
6%
Rash maculo-papular
6%
Febrile neutropenia
6%
Rhinorrhoea
6%
Dyspepsia
6%
Pain in extremity
6%
Abdominal pain upper
5%
Dehydration
5%
Insomnia
5%
Productive cough
5%
Dry mouth
4%
Muscle spasms
4%
Paraesthesia
4%
Pneumonitis
3%
Renal failure acute
3%
Toxic skin eruption
3%
Hypotension
3%
General physical health deterioration
3%
Gastroenteritis
2%
Gastritis
2%
Pneumonia pseudomonas aeruginosa
2%
Pancytopenia
2%
Cardiac failure
2%
Sepsis
2%
Pneumocystis jirovecii pneumonia
2%
Pneumonia pneumococcal
2%
Pulmonary embolism
1%
Pleural haemorrhage
1%
Respiratory failure
1%
Enterocolitis
1%
Urinary tract infection
1%
Upper gastrointestinal haemorrhage
1%
Streptococcal sepsis
1%
Skin infection
1%
Pneumonia staphylococcal
1%
Pneumonia aspiration
1%
Pneumonia klebsiella
1%
Interstitial lung disease
1%
Mental impairment
1%
Rash erythematous
1%
Proctitis
1%
Fungal oesophagitis
1%
Accidental overdose
1%
Intestinal adenocarcinoma
1%
Deep vein thrombosis
1%
Haemolytic anaemia
1%
Atrial fibrillation
1%
Cardiac failure congestive
1%
Myocardial infarction
1%
Pericarditis
1%
Death
1%
Mucosal inflammation
1%
Multi-organ failure
1%
Sudden death
1%
Transitional cell carcinoma
1%
Bronchiolitis
1%
Bronchitis viral
1%
Bronchopneumonia
1%
Cytomegalovirus colitis
1%
Pneumonia escherichia
1%
Pneumonia mycoplasmal
1%
Septic shock
1%
Streptococcal bacteraemia
1%
Subdural haematoma
1%
Lipase increased
1%
Nephrolithiasis
1%
Renal colic
1%
Renal failure
1%
Renal failure chronic
1%
Lung disorder
1%
Ventricular tachycardia
1%
Colitis ischaemic
1%
Enteritis
1%
Pancreatitis acute
1%
Ileal ulcer
1%
Aspergillus infection
1%
Bronchopulmonary aspergillosis
1%
Campylobacter gastroenteritis
1%
Clostridium difficile colitis
1%
Fungal infection
1%
Influenza
1%
Pseudomonal sepsis
1%
Lower respiratory tract infection
1%
Pneumonia bacterial
1%
Enterococcal infection
1%
Enterococcal sepsis
1%
Escherichia sepsis
1%
Escherichia urinary tract infection
1%
Gastroenteritis viral
1%
Haemophilus infection
1%
Infection
1%
Infusion site cellulitis
1%
Lobar pneumonia
1%
Lower respiratory tract infection viral
1%
Lung infection
1%
Pneumonia respiratory syncytial viral
1%
Pneumonia streptococcal
1%
Pseudomonas bronchitis
1%
Wound infection staphylococcal
1%
Cervical vertebral fracture
1%
Femur fracture
1%
Traumatic haematoma
1%
Malnutrition
1%
Hyponatraemia
1%
Tumour lysis syndrome
1%
Arthritis
1%
Bone pain
1%
Malignant melanoma
1%
Brain stem haemorrhage
1%
Dementia
1%
Acute respiratory distress syndrome
1%
Acute respiratory failure
1%
Chronic obstructive pulmonary disease
1%
Dermatitis exfoliative
1%
Thrombosis
1%
Infusion related reaction
1%
Neuroendocrine tumour
1%
Pleural effusion
1%
Mallory-Weiss syndrome
1%
Diverticulitis
1%
Pyelonephritis
1%
Haemorrhagic stroke
1%
Dermatitis allergic
1%
Respiratory tract infection bacterial
1%
Splenic rupture
1%
Neuroendocrine carcinoma of the skin
100%
80%
60%
40%
20%
0%
Study treatment Arm
Duvelisib
Ofatumumab

Trial Design

1Treatment groups
Experimental Treatment
Group I: OfatumumabExperimental Treatment1 Intervention
Loading dose 300 mg by vein on Day 1 of Cycle 1; and full dose 1000 mg over 4 hours 1 time each week for 7 additional weekly doses (8 doses).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ofatumumab
2013
Completed Phase 3
~1470

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,966 Previous Clinical Trials
1,804,803 Total Patients Enrolled
GlaxoSmithKlineIndustry Sponsor
4,750 Previous Clinical Trials
8,067,408 Total Patients Enrolled
William G. Weirda, BS,MD,PhDStudy ChairM.D. Anderson Cancer Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available vacancies in this ongoing clinical trial?

"Unfortunately, this trial is no longer recruiting patients. The listing was created on March 1st, 2011 but has not been updated since February 23rd, 2022. However, there are 1577 active clinical trials for leukemia and lymphoid cancers as well as 23 studies involving Ofatumumab that are currently seeking participants."

Answered by AI

Are there any reported side effects of using Ofatumumab?

"While there is data supporting ofatumumab's safety, it only received a score of 2 because efficacy has not been proven in clinical trials."

Answered by AI

Has a study like this ever been conducted before?

"GlaxoSmithKline first sponsored research for Ofatumumab in 2010. The drug went through Phase 2 approvals after the first study, which only involved 32 patients. Now, there are 23 active trials in 45 countries and 290 cities."

Answered by AI

How many individuals are being treated as part of this study?

"Unfortunately, this particular study is not currently recruiting patients. It was initially posted on March 1st 2011 and last updated February 23rd, 2022. However, there are 1577 other clinical trials for leukemia patients and 23 studies involving Ofatumumab that are actively looking for participants."

Answered by AI

What are the most frequent indications for Ofatumumab?

"While most typically used to treat multiple sclerosis, ofatumumab can also help patients who are unresponsive to fludarabine and alemtuzumab or those ineligible for fludarabine-based therapy manage active secondary progressive multiple sclerosis."

Answered by AI

Can you give some examples of other research done with Ofatumumab?

"Out of the 23 ongoing clinical trials for Ofatumumab, 6 have reached Phase 3. Most research is being conducted out of Houston, Texas; however, there are 749 total locations across the world where these studies are taking place."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Ofatumumab for High-Risk Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
2011. "Ofatumumab for High-Risk Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01243190.
~3 spots leftby Apr 2025
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