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Alemtuzumab + Ofatumumab for CLL

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byShuo Ma

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Northwestern University

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This phase II trial studies the side effects and how well giving alemtuzumab and ofatumumab together works in treating patients with previously untreated chronic lymphocytic leukemia (CLL). Monoclonal antibodies, such as alemtuzumab and ofatumumab, can block cancer growth in different ways. Some block the ability of cancer to grow and spread. Others find cancer cells and help kill them or carry cancer killing substances to them. Giving alemtuzumab together with ofatumumab may kill more cancer cells

Research Team

Shuo Ma

Principal Investigator

Northwestern University

Eligibility Criteria

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.

Inclusion Criteria

Alkaline phosphatase must be no more than 2.5 times upper limit of normal

Total bilirubin must be less than 2 mg/dl

Serum creatinine must be less than 2.0 mg/dl

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Exclusion Criteria

I am committed to using effective birth control.

Patients with known human immunodeficiency virus (HIV) are NOT eligible

Patients with positive serology for Hepatitis B (HB) are NOT eligible

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Treatment Details

Interventions

Alemtuzumab (Monoclonal Antibodies)
Biopsy (Procedure)
Ofatumumab (Monoclonal Antibodies)

Trial OverviewThe 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.

Participant Groups

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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Dr. Jeffrey Sherman

Northwestern University

Chief Medical Officer

MD from Northwestern University

Dr. Alicia Löffler

Northwestern University

Chief Executive Officer since 2010

PhD from the University of Massachusetts at Amherst, post-doctoral training at Caltech

GlaxoSmithKline

Industry Sponsor

Trials

4,834

Recruited

8,389,000+

Headquarters

London, UK

Known For

Vaccines & Medicines

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