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Ofatumumab for Leukemia

Phase 2
Waitlist Available
Led By William G Wierda, MD
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
Patients (CR, nPR, or PR at enrollment) must have measurable disease, which may include MRD by 4-color flow cytometry.
Age >/= 18 years.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up start of study drug up to 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing if ofatumumab can help treat CLL or SLL that hasn't responded to chemotherapy. They will also be monitoring for safety.

Who is the study for?
This trial is for adults over 18 with CLL or SLL who have had chemotherapy or chemoimmunotherapy and are currently not progressing. They must be within certain time frames post-treatment, practice birth control, and have adequate kidney and liver function. Those with severe active infections or ongoing cancer treatments cannot participate.
What is being tested?
The study tests if Ofatumumab can help control remaining leukemia or lymphoma cells after initial treatment. It's also looking at the drug's safety. Participants will receive Ofatumumab to see if it reduces minimal residual disease and helps maintain remission.
What are the potential side effects?
Possible side effects of Ofatumumab include infusion reactions (like fever, chills), low blood counts leading to increased infection risk, fatigue, nausea, diarrhea, and potential liver enzyme changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My cancer is responding to treatment and can be measured for progress.
Select...
I am 18 years old or older.
Select...
I can take care of myself and am up and about more than half of my waking hours.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~start of study drug up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and start of study drug up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Patients with Objective Response
Secondary study objectives
Progression-Free Survival (PFS)
Time-to-Treatment Failure (TTF)

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%
Asthenia
13%
Colitis
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%
Arthralgia
7%
Pruritus
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%
Toxic skin eruption
3%
Hypotension
3%
Renal failure acute
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%
Urinary tract infection
1%
Pneumonia klebsiella
1%
Accidental overdose
1%
Respiratory failure
1%
Streptococcal sepsis
1%
Skin infection
1%
Pneumonia staphylococcal
1%
Interstitial lung disease
1%
Rash erythematous
1%
Pneumonia aspiration
1%
Fungal oesophagitis
1%
Pleural haemorrhage
1%
Upper gastrointestinal haemorrhage
1%
Proctitis
1%
Enterocolitis
1%
Mental impairment
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: OfatumumabExperimental Treatment1 Intervention
Ofatumumab 300 mg dose 1, then 1,000 mg weekly \* 7, (treatment) then 1,000 mg every 2 months beginning on week 12 for a total of 2 years of treatment or until progression (maintenance) of disease. The follow-up period will be the period after completion of maintenance.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ofatumumab
2013
Completed Phase 3
~1460

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,074 Previous Clinical Trials
1,803,587 Total Patients Enrolled
464 Trials studying Leukemia
31,791 Patients Enrolled for Leukemia
GlaxoSmithKlineIndustry Sponsor
4,815 Previous Clinical Trials
8,384,529 Total Patients Enrolled
47 Trials studying Leukemia
2,137 Patients Enrolled for Leukemia
William G Wierda, MDPrincipal InvestigatorM.D. Anderson Cancer Center

Media Library

Ofatumumab Clinical Trial Eligibility Overview. Trial Name: NCT01258933 — Phase 2
Leukemia Research Study Groups: Ofatumumab
Leukemia Clinical Trial 2023: Ofatumumab Highlights & Side Effects. Trial Name: NCT01258933 — Phase 2
Ofatumumab 2023 Treatment Timeline for Medical Study. Trial Name: NCT01258933 — Phase 2
~0 spots leftby Dec 2025
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