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Monoclonal Antibodies

Alemtuzumab + Ofatumumab for CLL

Phase 2
Waitlist Available
Led By Shuo Ma, MD, PhD
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group

Summary

This trialtests combining 2 monoclonal antibodies to see if it can kill more cancer cells in untreated CLL.

Who is the study for?
This trial is for adults with untreated chronic lymphocytic leukemia (CLL) who need treatment due to symptoms or blood abnormalities. They must be in good enough health to participate, not have other active cancers except certain skin cancers or localized breast/cervical cancer, and can't have serious heart conditions, hepatitis B or C, HIV, recent strokes, or uncontrolled medical issues.
What is being tested?
The study tests the combination of two monoclonal antibodies—alemtuzumab and ofatumumab—in patients with CLL. These drugs are designed to target cancer cells by blocking their growth and helping the immune system destroy them. The trial aims to see how well these drugs work together when given for the first time to those with CLL.
What are the potential side effects?
Potential side effects include infusion reactions where the drug enters the body, weakened immunity leading to infections, allergic responses specific to each drug's components, possible anemia from bone marrow suppression by alemtuzumab and ofatumumab as they attack cancerous white blood cells.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 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
Best Response as Defined by the iwCLL2008 (International Workshop on Chronic Lymphocytic Leukemia 2008)
Secondary study objectives
Compare Efficacy Between This Study and Historical Control Study of Alemtuzumab-rituximab
Correlation of Disease Characteristics With Disease Outcomes
Survival Rates

Side effects data

From 2009 Phase 4 trial • 501 Patients • NCT00113269
59%
Anaemia
58%
Leukopenia
26%
Diarrhoea
23%
Hyperlipidaemia
20%
Urinary tract infection
17%
Complications of transplanted kidney
14%
Nausea
10%
Thrombocytopenia
10%
Vomiting
10%
BK Viris infection
10%
Hyperglycaemia
10%
Hypertension
9%
Pneumonia
9%
Bronchitis
9%
Upper respiratory tract infection
7%
Blood creatinine increased
7%
Urinary tract infection bacterial
6%
Cytomegalovirus infection
6%
Therapeutic agent toxicity
4%
Transplant rejection
4%
Pyelonephritis
4%
Neutropenia
3%
Bk virus infection
3%
Sepsis
3%
Gastrointestinal haemorrhage
3%
Cardiac arrest
3%
Cardiac failure congestive
3%
Chest pain
3%
Escherichia urinary tract infection
1%
Death
1%
Heparin-induced thrombocytopenia
1%
Parathyroid tumour benign
1%
Renal impairment
1%
Cytomegalovirus viraemia
1%
Bacterial sepsis
1%
Candidiasis
1%
Cellulitis
1%
Clostridial infection
1%
Escherichia sepsis
1%
Gastroenteritis viral
1%
Lobar pneumonia
1%
Lung infection pseudomonal
1%
Postoperative wound infection
1%
Viral infection
1%
Hepatic enzyme increased
1%
Pulmonary function test increased
1%
Pulmonary embolism
1%
Pleural effusion
1%
Post procedural complication
1%
Post procedural haemorrhage
1%
Postoperative thrombosis
1%
Vascular graft complication
1%
Diabetic ketoacidosis
1%
Fluid overload
1%
Hyperkalaemia
1%
Hypovolaemia
1%
Metabolic disorder
1%
Mouth ulceration
1%
Hypotension
1%
Aneurysm arteriovenous
1%
Lymphocele
1%
Pulmonary hypertension
1%
Peripheral ischaemia
1%
Subclavian vein thrombosis
1%
Disseminated intravascular coagulation
1%
Febrile neutropenia
1%
Haemolytic uraemic syndrome
1%
Acute myocardial infarction
1%
Myocardial infarction
1%
Cholelithiasis
1%
Portal hypertension
1%
Parathyroidectomy
1%
Hyperparathyroidism
1%
Myositis
1%
Diabetes mellitus
1%
Tremor
100%
80%
60%
40%
20%
0%
Study treatment Arm
Conventional High-Risk Patients
Alemtuzumab Low- Risk Patients
Conventional Low-Risk Patients
Alemtuzumab High-Risk Patients

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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: Treatment (monoclonal antibody therapy)Experimental Treatment3 Interventions
Patients receive alemtuzumab SC three times a week in weeks 1-18 and ofatumumab IV over 4-6 hours on day 1 of weeks 3, 5, 7, 9, 11, 13, 15, and 17.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Alemtuzumab
FDA approved
Ofatumumab
FDA approved
biopsy
2002
Completed Phase 4
~8270

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor
1,649 Previous Clinical Trials
958,718 Total Patients Enrolled
GlaxoSmithKlineIndustry Sponsor
4,812 Previous Clinical Trials
8,382,144 Total Patients Enrolled
National Comprehensive Cancer NetworkNETWORK
120 Previous Clinical Trials
7,969 Total Patients Enrolled
Shuo Ma, MD, PhDPrincipal InvestigatorNorthwestern University
2 Previous Clinical Trials
30 Total Patients Enrolled
~4 spots leftby Dec 2025
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