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Monoclonal Antibodies

alemtuzumab for Chronic Lymphocytic Leukemia

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

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Best Response as Defined by the iwCLL2008 (International Workshop on Chronic Lymphocytic Leukemia 2008)

Secondary outcome measures

Compare Efficacy Between This Study and Historical Control Study of Alemtuzumab-rituximab

Correlation of Disease Characteristics With Disease Outcomes

Survival Rates

+1 more

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%

Hypertension

10%

Vomiting

10%

Thrombocytopenia

10%

BK Viris infection

10%

Hyperglycaemia

Upper respiratory tract infection

Bronchitis

Pneumonia

Blood creatinine increased

Urinary tract infection bacterial

Cytomegalovirus infection

Therapeutic agent toxicity

Neutropenia

Pyelonephritis

Transplant rejection

Escherichia urinary tract infection

Bk virus infection

Gastrointestinal haemorrhage

Sepsis

Cardiac arrest

Cardiac failure congestive

Chest pain

Hypotension

Fluid overload

Lymphocele

Gastroenteritis viral

Cytomegalovirus viraemia

Bacterial sepsis

Candidiasis

Hypovolaemia

Aneurysm arteriovenous

Renal impairment

Cellulitis

Clostridial infection

Escherichia sepsis

Lung infection pseudomonal

Postoperative wound infection

Viral infection

Hepatic enzyme increased

Pulmonary function test increased

Post procedural complication

Postoperative thrombosis

Hyperkalaemia

Mouth ulceration

Peripheral ischaemia

Subclavian vein thrombosis

Febrile neutropenia

Haemolytic uraemic syndrome

Acute myocardial infarction

Myocardial infarction

Death

Heparin-induced thrombocytopenia

Pulmonary embolism

Pleural effusion

Pulmonary hypertension

Cholelithiasis

Portal hypertension

Parathyroidectomy

Hyperparathyroidism

Myositis

Diabetes mellitus

Tremor

Lobar pneumonia

Vascular graft complication

Parathyroid tumour benign

Post procedural haemorrhage

Diabetic ketoacidosis

Metabolic disorder

Disseminated intravascular coagulation

100%

80%

60%

40%

20%

Study treatment Arm

Conventional High-Risk Patients

Alemtuzumab Low- Risk Patients

Conventional Low-Risk Patients

Alemtuzumab High-Risk Patients

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor

1,585 Previous Clinical Trials

917,178 Total Patients Enrolled

GlaxoSmithKlineIndustry Sponsor

4,751 Previous Clinical Trials

8,067,419 Total Patients Enrolled

National Comprehensive Cancer NetworkNETWORK

115 Previous Clinical Trials

7,582 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How secure is the application of alemtuzumab in human subjects?

"Based on the existing clinical data, alemtuzumab received a score of 2. This is due to Phase 2 trials providing some evidence for safety but not yet any validation regarding efficacy."

Answered by AI

How many participants has this clinical trial enrolled thus far?

"This clinical trial is no longer accepting enrolment, having been initially posted on June 1st 2011 and last updated October 4th 2022. For those seeking alternative trials, 1516 studies are currently recruiting patients with leukemias such as lymphocytic chronic B-cell, while 53 research initiatives are actively looking for volunteers to participate in alemtuzumab testing."

Answered by AI

Could you enumerate any other experiments utilizing alemtuzumab?

"At the moment, 53 clinical trials are underway that explore alemtuzumab with 8 of those entering Phase 3. Philadelphia is conducting most of these studies but there are 924 locations in total for this medication's research."

Answered by AI

What medical applications is alemtuzumab typically utilized for?

"Alemtuzumab is typically employed to treat autoimmune hemolytic anemia, but has also been utilized for multiple sclerosis management, organ transplant rejection prevention, and B-lymphocyte regulation."

Answered by AI

Are there any vacancies available for participants to join this experimentation?

"Data hosted on clinicaltrials.gov reveals that this study is not actively seeking individuals for enrollment at the moment. Initially posted in June of 2011 and last edited on October 4th 2022, it appears there are 1569 other medical trials currently accepting participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Alemtuzumab-Ofatumumab in Previously Untreated Symptomatic Chronic Lymphocytic Leukemia

Shuo Ma 2011. "Alemtuzumab-Ofatumumab in Previously Untreated Symptomatic Chronic Lymphocytic Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01361711.

All > Acute Myelogenous Leukemia > Chronic Lymphocytic Leukemia