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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
Must not have
Use of any other experimental drug or therapy within 28 days of baseline
Development of erythema nodosum while taking thalidomide or similar drugs
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 56 months
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
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My leukemia or lymphoma is CD5+ and CD20+ as confirmed by tests.
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I have not had any treatments for my CLL.
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I can take care of myself but might not be able to do heavy physical work.
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I can take aspirin daily.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I haven't used any experimental drugs or therapies in the last 28 days.
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I developed skin lumps after taking thalidomide or similar drugs.
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I have taken lenalidomide before.
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I am not using any other cancer treatments.
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I have an ongoing liver or bile duct condition.
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I am being treated for a long-term or current infection.
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I have a serious heart condition.
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I have a serious health condition that is not under control.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 56 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 56 months 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 Participants With Complete Response (CR)
Number of Participants With Partial Response (PR)
Secondary study objectives
Number of Participants With Overall Survival (OS)
Rate of Progression/Relapse Free Survival (PFS)

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%
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%
Urinary tract infection
1%
Pneumonia klebsiella
1%
Respiratory failure
1%
Streptococcal sepsis
1%
Interstitial lung disease
1%
Skin infection
1%
Accidental overdose
1%
Pneumonia staphylococcal
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: 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
~1460
Lenalidomide
2005
Completed Phase 3
~2240
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
564 Previous Clinical Trials
144,838 Total Patients Enrolled
NovartisIndustry Sponsor
1,638 Previous Clinical Trials
2,774,158 Total Patients Enrolled
Celgene CorporationIndustry Sponsor
445 Previous Clinical Trials
58,601 Total Patients Enrolled
Celeste Bello, M.D.Principal InvestigatorH. Lee Moffitt Cancer Center and Research Institute
2 Previous Clinical Trials
30 Total Patients Enrolled

Media Library

High Dose Methylprednisolone (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT01496976 — Phase 2
Chronic Lymphocytic Leukemia Research Study Groups: Immunotherapy
Chronic Lymphocytic Leukemia Clinical Trial 2023: High Dose Methylprednisolone Highlights & Side Effects. Trial Name: NCT01496976 — Phase 2
High Dose Methylprednisolone (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01496976 — Phase 2
~3 spots leftby Dec 2025
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