Study Summary
This study is evaluating whether giving alemtuzumab and ofatumumab together works better than giving alemtuzumab alone in treating patients with previously untreated chronic lymphocytic leukemia (CLL).
Eligible Conditions
- Leukemia, Lymphocytic, Chronic, B-Cell
- Lymphoid leukemia
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 4 Secondary · Reporting Duration: Up to 5 years
Week 18
Compare Efficacy Between This Study and Historical Control Study of Alemtuzumab-rituximab
Correlation of Disease Characteristics With Disease Outcomes
Month 2
Best Response as Defined by the iwCLL2008 (International Workshop on Chronic Lymphocytic Leukemia 2008)
Up to 5 years
Survival Rates
Week 1
Treatment Toxicity as Measured by Adverse Events Experienced While on Treatment
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Side Effects for
Conventional Low-Risk Patients
43%Anaemia
38%Diarrhoea
28%Leukopenia
22%Urinary tract infection
19%Hyperlipidaemia
13%Upper respiratory tract infection
12%Diabetes mellitus
11%Hypertension
8%Neutropenia
8%Complications of transplanted kidney
8%Therapeutic agent toxicity
8%Blood creatinine increased
6%Hyperglycaemia
6%Nausea
5%BK Viris infection
5%Vomiting
5%Bronchitis
5%Escherichia urinary tract infection
4%Renal failure acute
4%Cytomegalovirus infection
4%Tremor
3%Urinary tract infection bacterial
2%Urosepsis
2%Pyelonephritis
2%Hypovolaemia
2%Dehydration
2%Deep vein thrombosis
2%Pyrexia
2%Kidney transplant rejection
2%Thrombocytopenia
1%Cytomegalovirus viraemia
1%Postoperative infection
1%Tinea versicolour
1%Thrombophlebitis superficial
1%Abdominal pain
1%Odynophagia
1%Pneumonia
1%Bk virus infection
1%Gastroenteritis
1%Sepsis
1%Cellulitis
1%Cytomegalovirus colitis
1%Gastroenteritis viral
1%Respiratory tract infection
1%Sinusitis
1%Gangrene
1%Wound infection
1%Appendicitis
1%Bronchiectasis
1%Candida osteomyelitis
1%Campylobacter intestinal infection
1%Hyperkalaemia
1%Cytomegalovirus oesophagitis
1%Gastroenteritis cryptosporidial
1%Ear infection
1%Diverticulitis
1%Gastroenteritis norwalk virus
1%Meningitis viral
1%Pericarditis infective
1%Pneumonia fungal
1%Fluid overload
1%Pneumonitis cryptococcal
1%Respiratory tract infection fungal
1%Staphylococcal infection
1%Urinary tract infection enterococcal
1%Post procedural urine leak
1%Road traffic accident
1%Hyponatraemia
1%Hypokalaemia
1%Gastritis
1%Crohn's disease
1%Dysphagia
1%Haemorrhoids
1%Gastrooesophageal reflux disease
1%Impaired gastric emptying
1%Pancreatitis acute
1%Hypotension
1%Stomatitis
1%Thrombotic microangiopathy
1%Febrile neutropenia
1%Pancytopenia
1%Leukocytosis
1%Myocardial infarction
1%Atrial fibrillation
1%Coronary artery disease
1%Cardiac failure congestive
1%Coronary artery atherosclerosis
1%Cardiac tamponade
1%Mitral valve incompetence
1%Aortic valve stenosis
1%Chills
1%Pericardial effusion
1%Chest pain
1%Tricuspid valve incompetence
1%Squamous cell carcinoma of skin
1%Basal cell carcinoma
1%Lung adenocarcinoma
1%Lung neoplasm malignant
1%Renal impairment
1%Hydronephrosis
1%Ureteric stenosis
1%Oliguria
1%Renal vein thrombosis
1%Hypoglycaemic encephalopathy
1%Nephritis interstitial
1%Haemorrhage urinary tract
1%Ureteric obstruction
1%Dyspnoea
1%Pneumonitis
1%Cholelithiasis
1%Respiratory acidosis
1%Arthralgia
1%Back pain
1%Mental status changes
1%Myalgia
1%Rheumatoid arthritis
1%Flank pain
1%Pregnancy
Trial Design
1 Treatment Group
Treatment (monoclonal antibody therapy)
1 of 1
Experimental Treatment
53 Total Participants · 1 Treatment Group
Primary Treatment: alemtuzumab · No Placebo Group · Phase 2
Treatment (monoclonal antibody therapy)Experimental Group · 3 Interventions: alemtuzumab, ofatumumab, biopsy · Intervention Types: Biological, Biological, Procedure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Alemtuzumab
FDA approved
Ofatumumab
FDA approved
biopsy
2002
Completed Phase 4
~5750
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years
Who is running the clinical trial?
Northwestern UniversityLead Sponsor
1,434 Previous Clinical Trials
769,705 Total Patients Enrolled
1 Trials studying Leukemia, Lymphocytic, Chronic, B-Cell
20 Patients Enrolled for Leukemia, Lymphocytic, Chronic, B-Cell
GlaxoSmithKlineIndustry Sponsor
4,640 Previous Clinical Trials
7,946,268 Total Patients Enrolled
31 Trials studying Leukemia, Lymphocytic, Chronic, B-Cell
1,669 Patients Enrolled for Leukemia, Lymphocytic, Chronic, B-Cell
National Comprehensive Cancer NetworkNETWORK
108 Previous Clinical Trials
5,588 Total Patients Enrolled
Shuo Ma, MD, PhDPrincipal InvestigatorNorthwestern University
1 Previous Clinical Trials
30 Total Patients Enrolled
1 Trials studying Leukemia, Lymphocytic, Chronic, B-Cell
30 Patients Enrolled for Leukemia, Lymphocytic, Chronic, B-Cell
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:About The Reviewer
Michael Gill - B. Sc.
First Published: October 6th, 2021
Last Reviewed: November 14th, 2022
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
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Conditions
Cancer Related
Treatments