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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 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

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 • NCT02004522
21%
Neutropenia
18%
Infusion related reaction
14%
Cough
12%
Diarrhoea
12%
Fatigue
12%
Rash
11%
Nausea
11%
Asthenia
10%
Anaemia
10%
Paraesthesia
10%
Pyrexia
8%
Constipation
8%
Headache
8%
Upper respiratory tract infection
8%
Bronchitis
6%
Pruritus
6%
Vomiting
6%
Dyspnoea
6%
Thrombocytopenia
6%
Insomnia
6%
Paraesthesia oral
5%
Hypotension
5%
Back pain
5%
Muscle spasms
5%
Oedema peripheral
3%
Dizziness
3%
Arthralgia
3%
Hypertension
3%
Hyperkalaemia
3%
Pneumonia
3%
Abdominal pain upper
3%
Nasopharyngitis
3%
Decreased appetite
3%
Dyspepsia
2%
Febrile neutropenia
2%
Weight decreased
2%
Aspartate aminotransferase increased
2%
Alanine aminotransferase increased
2%
Abdominal pain
2%
Hypokalaemia
2%
Rhinorrhoea
2%
Escherichia sepsis
2%
Respiratory tract infection
2%
Pain in extremity
1%
Rash maculo-papular
1%
Colitis
1%
Clostridium difficile infection
1%
Cardiac failure
1%
Productive cough
1%
Dehydration
1%
Neutropenic sepsis
1%
Sepsis
1%
Deep vein thrombosis
1%
Haemolytic anaemia
1%
Lymph node pain
1%
Atrial fibrillation
1%
Disease progression
1%
Cholecystitis
1%
Drug hypersensitivity
1%
Streptococcal bacteraemia
1%
Device related infection
1%
Herpes virus infection
1%
Ischaemic stroke
1%
Renal failure acute
1%
Angina pectoris
1%
Oesophageal ulcer
1%
Portal hypertensive gastropathy
1%
Infusion site extravasation
1%
Hepatic failure
1%
Contrast media allergy
1%
Pneumonia bacterial
1%
Escherichia urinary tract infection
1%
Pneumonia viral
1%
Gastroenteritis
1%
Fall
1%
Hyponatraemia
1%
Hypercalcaemia
1%
Hyperglycaemia
1%
Hypervolaemia
1%
Malignant melanoma
1%
Glioblastoma multiforme
1%
Malignant pleural effusion
1%
Squamous cell carcinoma
1%
Squamous cell carcinoma of lung
1%
Pulmonary embolism
1%
Laryngeal stenosis
1%
Peripheral embolism
1%
Dry mouth
1%
Tachycardia
1%
Enterocolitis
1%
Lower respiratory tract infection
1%
Chronic sinusitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ofatumumab
Duvelisib

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
2,958 Previous Clinical Trials
1,798,405 Total Patients Enrolled
451 Trials studying Leukemia
31,487 Patients Enrolled for Leukemia
GlaxoSmithKlineIndustry Sponsor
4,742 Previous Clinical Trials
8,066,317 Total Patients Enrolled
47 Trials studying Leukemia
2,161 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

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
~1 spots leftby Jul 2024