Alemtuzumab + Ofatumumab for CLL

Not currently recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Northwestern University

Must not be taking: Antibiotics, Antivirals

Disqualifiers: Autoimmune anemia, Hepatitis B, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 18 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of two monoclonal antibodies, alemtuzumab and ofatumumab, in treating chronic lymphocytic leukemia (CLL), a type of blood cancer. Monoclonal antibodies aim to stop cancer cells from growing and spreading or help destroy them. The treatment consists of a series of injections and infusions over several weeks. Individuals diagnosed with CLL who experience symptoms like significant weight loss, fatigue, or fever without infection may be suitable for the trial. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of people, offering participants a chance to contribute to important advancements in CLL treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but prior cytotoxic therapies are not allowed, except for certain corticosteroids which must be stopped at least one week before joining the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that alemtuzumab has been studied for treating chronic lymphocytic leukemia (CLL) and is known for targeting and killing cancer cells. However, more information is needed about its safety and potential risks.

In contrast, ofatumumab has been well-tolerated by CLL patients. Studies have demonstrated that it has manageable side effects, even at high doses, and has been effective for patients unresponsive to other treatments.

The goal of combining alemtuzumab and ofatumumab is to enhance their cancer-fighting abilities. Although less information exists about their combined use, each drug has shown promise individually. Participants might experience side effects, but the aim is to balance effectiveness and safety. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Alemtuzumab and Ofatumumab for treating Chronic Lymphocytic Leukemia (CLL) because they offer a unique approach compared to standard therapies like chemotherapy and other monoclonal antibodies. Alemtuzumab targets CD52, a protein found on the surface of cancerous and healthy immune cells, leading to their destruction. Ofatumumab, on the other hand, targets the CD20 protein specifically on B-cells, which are often cancerous in CLL, helping to eliminate them more effectively. This combination of targeted mechanisms not only potentially increases treatment effectiveness but may also reduce side effects associated with broader-acting therapies.

What evidence suggests that alemtuzumab and ofatumumab might be an effective treatment for CLL?

In this trial, participants will receive a combination of alemtuzumab and ofatumumab to treat chronic lymphocytic leukemia (CLL). Studies have shown that both alemtuzumab and ofatumumab effectively treat CLL. Alemtuzumab targets specific proteins on cancer cells, aiding the immune system in attacking and killing these cells. Research indicates that ofatumumab also assists by attaching to cancer cells, making it easier for the body to destroy them. Previous patients responded well when these two monoclonal antibodies were used together. This combination aims to improve outcomes by using both drugs to attack the cancer in different ways. ^{1 2 6 7 8}

Who Is on the Research Team?

Shuo Ma

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

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

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive alemtuzumab subcutaneously three times a week for 18 weeks and ofatumumab intravenously on specific weeks

18 weeks

Alemtuzumab: 3 visits per week; Ofatumumab: 8 visits over 18 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

• Alemtuzumab
• Biopsy
• Ofatumumab

Trial Overview 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.

How Is the Trial Designed?

Group I: Treatment (monoclonal antibody therapy) Experimental Treatment 3 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.

Alemtuzumab is already approved in United States, European Union for the following indications:

Approved in United States as Campath for:

• Chronic lymphocytic leukemia
• Multiple sclerosis

Approved in European Union as Lemtrada for:

• Multiple sclerosis

Approved in European Union as Campath for:

• Chronic lymphocytic leukemia

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

GlaxoSmithKline

Industry Sponsor

Trials

4,834

Recruited

8,389,000+

Headquarters

London, UK

Known For

Vaccines & Medicines

Top Products

**Advair (salmeterol, fluticasone propionate)**, **Shingrix (shingles vaccine)**, **Augmentin (amoxicillin/clavulanate potassium)**, **Ventolin (salbutamol sulfate)

Dame Emma Walmsley

GlaxoSmithKline

Chief Executive Officer since 2017

MA in Classics and Modern Languages from Oxford University

Dr. Hal Barron

GlaxoSmithKline

Chief Medical Officer since 2018

MD from Harvard Medical School

National Comprehensive Cancer Network

Collaborator

Trials

121

Recruited

7,400+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28559746/

Estimating outcomes and cost effectiveness using a single ... Estimating outcomes and cost effectiveness using a single-arm clinical trial: ofatumumab for double-refractory chronic lymphocytic leukemia.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT01361711

Study Details | NCT01361711 | Alemtuzumab-Ofatumumab ... This phase II trial studies the side effects and how well giving alemtuzumab and ofatumumab together works in treating patients with previously untreated ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6486055/

Alemtuzumab for patients with chronic lymphocytic leukaemia We are aiming to obtain more evidence regarding the clinical benefit (OS, PFS, response rate) and the therapy‐related risks (treatment‐related mortality (TRM), ...

4. divisionofresearch.kaiserpermanente.org divisionofresearch.kaiserpermanente.org/publications/estimating-outcomes-and-cost-effectiveness-using-a-single-arm-clinical-trial-ofatumumab-for-double-refractory-chronic-lymphocytic-leukemia/

Estimating outcomes and cost effectiveness using a single- ... METHODS:The objective of the study was to present a method to estimate the cost effectiveness of ofatumumab in the treatment of DR-CLL. As no suitable ...

5. haematologica.org haematologica.org/article/view/9646

final results of the NCRI CLL210 trial In summary, although the NCRI CLL210 trial showed that lenalidomide and dexamethasone combined with either alemtuzumab of ofatumumab is feasible and active in ...

6. haematologica.org haematologica.org/article/view/7343

Ofatumumab in poor-prognosis chronic lymphocytic leukemia This study confirms in a daily-life setting the feasibility and acceptable toxicity of ofatumumab treatment in advanced chronic lymphocytic leukemia.

7. ashpublications.org ashpublications.org/blood/article/111/3/1094/25378/Safety-and-efficacy-of-ofatumumab-a-fully-human

Safety and efficacy of ofatumumab, a fully human monoclonal ... In conclusion, ofatumumab was found to be well tolerated in patients with chronic lymphocytic leukemia (CLL) in doses up to 2000 mg. Preliminary data on safety ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4916553/

Ofatumumab is active in patients with fludarabine-refractory ... Ofatumumab monotherapy was effective and well tolerated in patients with fludarabine-refractory chronic lymphocytic leukemia, including in patients with ...