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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
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ start of study drug up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~start of study drug up to 2 years
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 Objective Response
Secondary outcome measures
Progression-Free Survival (PFS)
Time-to-Treatment Failure (TTF)
Side effects data
From 2021 Phase 3 trial • 319 Patients • NCT0200452250%
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%
Dyspnoea
9%
Aspartate aminotransferase increased
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%
Toxic skin eruption
3%
Renal failure acute
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%
Enterocolitis
1%
Pneumonia staphylococcal
1%
Urinary tract infection
1%
Pneumonia klebsiella
1%
Upper gastrointestinal haemorrhage
1%
Respiratory failure
1%
Skin infection
1%
Mental impairment
1%
Streptococcal sepsis
1%
Pleural haemorrhage
1%
Proctitis
1%
Rash erythematous
1%
Pneumonia aspiration
1%
Interstitial lung disease
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
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
~1470
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,976 Previous Clinical Trials
1,789,464 Total Patients Enrolled
452 Trials studying Leukemia
31,496 Patients Enrolled for Leukemia
GlaxoSmithKlineIndustry Sponsor
4,758 Previous Clinical Trials
8,104,101 Total Patients Enrolled
47 Trials studying Leukemia
2,161 Patients Enrolled for Leukemia
William G Wierda, MDPrincipal InvestigatorM.D. Anderson Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer is responding to treatment and can be measured for progress.I am 18 years old or older.I have CLL or SLL, treated with chemo, and my disease hasn't worsened 3-12 months after my last treatment.My kidney and liver are functioning well, with creatinine and bilirubin levels below 2 mg/dL.I have tested positive for Hepatitis B.I can become pregnant or father a child and agree to use birth control during the study.I am not currently receiving chemotherapy, radiotherapy, or immunotherapy.I do not have any active infections or serious illnesses, including liver diseases.I can take care of myself and am up and about more than half of my waking hours.
Research Study Groups:
This trial has the following groups:- Group 1: Ofatumumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are being surveyed in this clinical research?
"This research is not currently looking for new participants. The listing was first posted on July 1st, 2011 and the most recent update occurred on June 29th, 2022. There are 3200 other clinical trials exploring treatments for lymphoma and 23 Ofatumumab studies that are admitting patients if you wish to explore other options."
Answered by AI
Have similar trials been conducted before this one?
"Ofatumumab has had a long clinical history, with the first study being completed in 2010 by GlaxoSmithKline. After the Phase 1 drug trial involving 32 patients, Ofatumumab received approval for Phase 2 trials. Presently, there are 23 ongoing studies in 290 different cities and 45 countries."
Answered by AI
Can Ofatumumab be legally prescribed in the United States?
"Ofatumumab's safety is estimated to be a 2. While there is some evidence that it is safe, none of the data collected supports Ofatumumab's efficacy."
Answered by AI
Has Ofatumumab been part of other research studies in the past?
"There are currently 23 clinical trials researching Ofatumumab with 6 in Phase 3. While some of the research is taking place in Houston, Texas, there are 749 total locations running studies for this medication."
Answered by AI
When is Ofatumumab given to patients?
"Ofatumumab is used to treat multiple sclerosis, as well as refractory fludarabine and alemtuzumab patients that are ineligible for fludarabine-based therapy. It can also help those with active secondary progressive multiple sclerosis (spms)."
Answered by AI
Are there any patients still needed for this research study?
"No, this particular clinical trial is not enrolling patients at the moment. It was created on July 1st, 2011 and last updated June 29th, 2022 according to information found on clinicaltrials.gov. However, there are nearly 3000 other trials that are currently recruiting patients."
Answered by AI
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