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Corticosteroid
Ofatumumab + HDMP + Lenalidomide for Chronic Lymphocytic Leukemia
Phase 2
Waitlist Available
Led By Celeste Bello, M.D.
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have histologically or cytologically confirmed CD5+/CD20+ B-Cell chronic lymphocytic leukemia or small lymphocytic lymphoma based on NCCN guidelines
Patient has not received any prior treatment for CLL
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 56 months
Awards & highlights
Study Summary
This trial is testing if ofatumumab, a drug used to treat leukemia, in combination with methylprednisolone and lenalidomide, is safe and effective in treating people with CLL.
Who is the study for?
This trial is for adults with untreated Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL), who have not had other cancers in the last 5 years, except certain skin or 'in situ' cancers. Participants must meet specific disease criteria, be physically able to follow the study plan, and women of childbearing age must use two forms of birth control due to risks from one of the drugs.Check my eligibility
What is being tested?
Researchers are testing a combination therapy for CLL/SLL that starts with Ofatumumab and high-dose Methylprednisolone, followed by additional treatment with Ofatumumab and Lenalidomide. The goal is to see if this regimen can effectively eliminate leukemia cells and maintain remission over time while also being safe for patients.See study design
What are the potential side effects?
Possible side effects include reactions at the infusion site, changes in blood pressure during treatment, lowered immune system leading to increased infection risk, potential impact on blood cell counts causing anemia or bleeding issues, fatigue, rash or itching skin conditions related to drug sensitivity.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My leukemia or lymphoma is CD5+ and CD20+ as confirmed by tests.
Select...
I have not had any treatments for my CLL.
Select...
I can take care of myself but might not be able to do heavy physical work.
Select...
I can take aspirin daily.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 56 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 56 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants With Complete Response (CR)
Number of Participants With Partial Response (PR)
Secondary outcome measures
Number of Participants With Overall Survival (OS)
Rate of Progression/Relapse Free Survival (PFS)
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%
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%
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%
Urinary tract infection
1%
Upper gastrointestinal haemorrhage
1%
Skin infection
1%
Pneumonia aspiration
1%
Interstitial lung disease
1%
Respiratory failure
1%
Mental impairment
1%
Pleural haemorrhage
1%
Pneumonia klebsiella
1%
Streptococcal sepsis
1%
Rash erythematous
1%
Proctitis
1%
Pneumonia staphylococcal
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: ImmunotherapyExperimental Treatment3 Interventions
Combination Regimen Followed by Consolidative Therapy: Ofatumumab/High Dose Methylprednisolone (HDMP) plus Ofatumumab/Lenalidomide
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ofatumumab
2013
Completed Phase 3
~1470
Lenalidomide
2005
Completed Phase 3
~1480
High Dose Methylprednisolone (HDMP)
2012
Completed Phase 2
~30
Find a Location
Who is running the clinical trial?
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
542 Previous Clinical Trials
135,447 Total Patients Enrolled
NovartisIndustry Sponsor
1,611 Previous Clinical Trials
2,720,990 Total Patients Enrolled
Celgene CorporationIndustry Sponsor
444 Previous Clinical Trials
58,191 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't used any experimental drugs or therapies in the last 28 days.I developed skin lumps after taking thalidomide or similar drugs.I have taken lenalidomide before.I am not using any other cancer treatments.I have an ongoing liver or bile duct condition.I am being treated for a long-term or current infection.My blood tests show high lymphocyte counts and I have been diagnosed with CLL/SLL.My cancer is at an advanced stage or is active despite being at an early stage.I can take care of myself but might not be able to do heavy physical work.I have been cancer-free for at least 5 years, with some exceptions.I can take aspirin daily.I have a serious health condition that is not under control.My leukemia or lymphoma is CD5+ and CD20+ as confirmed by tests.I have had a major stroke or brain disease in the last 6 months.I have a serious heart condition.I have not had any treatments for my CLL.
Research Study Groups:
This trial has the following groups:- Group 1: Immunotherapy
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.
Are there any current vacancies for willing participants in this experiment?
"As of 8/15/2022, this trial is no longer recruiting patients. It was initially posted on 3/30/2012. There are presently 355 leukemia studies and 439 Ofatumumab trials admitting patients."
Answered by AI
How many people are allowed to be enrolled in this experiment at one time?
"This clinical trial is not recruiting patients at the moment. The original posting date was March 30th, 2012 and the most recent update occurred on August 15th, 2022. If you are looking for other studies, there are currently 355 clinical trials actively enrolling participants with leukemia, lymphocytic, chronic, b-cell and 439 studies for Ofatumumab actively admitting patients."
Answered by AI
How is Ofatumumab most often employed?
"Ofatumumab can be used to treat patients with ophthalmia, sympathetic, and scalp structure. Additionally, this medication can serve as a last-line of treatment for those who have failed at least two other systemic chemotherapy regimens."
Answered by AI
Has the FDA greenlit Ofatumumab for public consumption?
"There is some evidence suggesting ofatumumab's safety, but since this is only a Phase 2 trial, meaning that there is no data supporting efficacy, it received a score of 2."
Answered by AI
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