alemtuzumab for Leukemia, Lymphocytic, Chronic, B-Cell

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Leukemia, Lymphocytic, Chronic, B-Cell+6 More
alemtuzumab - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

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

1 of 3

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

2 of 3
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
This histogram enumerates side effects from a completed 2009 Phase 4 trial (NCT00113269) in the Conventional Low-Risk Patients ARM group. Side effects include: Anaemia with 43%, Diarrhoea with 38%, Leukopenia with 28%, Urinary tract infection with 22%, Hyperlipidaemia with 19%.

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 preview

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.