Alemtuzumab + Ofatumumab for CLL

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

53 Participants Needed

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

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.

What data supports the effectiveness of the drug combination Alemtuzumab and Ofatumumab for treating chronic lymphocytic leukemia (CLL)?

Alemtuzumab has shown effectiveness in treating chronic lymphocytic leukemia (CLL), with better response rates and progression-free survival compared to chlorambucil in untreated patients. Ofatumumab has been effective as a single-agent therapy in patients with CLL who are resistant to other treatments, indicating its potential benefit in combination with Alemtuzumab. ^{1 2 3 4 5}

Is the combination of Alemtuzumab and Ofatumumab generally safe for humans?

Alemtuzumab has been used in patients with rheumatoid arthritis, and long-term follow-up showed significant delays in immune system recovery, indicating potential safety concerns. However, specific safety data for the combination with Ofatumumab is not provided in the available research. ^{6 7 8 9 10}

How is the drug combination of Alemtuzumab and Ofatumumab unique for treating CLL?

The combination of Alemtuzumab and Ofatumumab is unique for treating chronic lymphocytic leukemia (CLL) because it targets two different antigens on cancer cells, CD52 and CD20, potentially offering a more comprehensive attack on the cancer cells. This dual-target approach may be beneficial for patients who are resistant to other treatments, as each drug has shown effectiveness in difficult-to-treat cases of CLL. ^{1 2 3 4 11}

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

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

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

Treatment Details

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.

Participant Groups

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+

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Experience with alemtuzumab in treatment of chronic lymphocytic leukaemia in the Netherlands. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Alemtuzumab for B-cell chronic lymphocytic leukemia. [2017]

3. United States pubmed.ncbi.nlm.nih.gov

Ofatumumab as single-agent CD20 immunotherapy in fludarabine-refractory chronic lymphocytic leukemia. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Fatal adenovirus infection during alemtuzumab (anti-CD52 monoclonal antibody) treatment of a patient with fludarabine-refractory B-cell chronic lymphocytic leukemia. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Fludarabine plus alemtuzumab (FA) front-line treatment in young patients with chronic lymphocytic leukemia (CLL) and an adverse biologic profile. [2017]

6. England pubmed.ncbi.nlm.nih.gov

Immune reconstitution 20 years after treatment with alemtuzumab in a rheumatoid arthritis cohort: implications for lymphocyte depleting therapies. [2022]

7. Spain pubmed.ncbi.nlm.nih.gov

Gateways to clinical trials. [2007]

8. Spain pubmed.ncbi.nlm.nih.gov

Gateways to clinical trials. [2007]

9. Spain pubmed.ncbi.nlm.nih.gov

Gateways to clinical trials. [2011]

10. England pubmed.ncbi.nlm.nih.gov

Safety and effectiveness of certolizumab pegol in Japanese patients with rheumatoid arthritis: Results from a 24-week post-marketing surveillance study. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Campath-1H and fludarabine in combination are highly active in refractory chronic lymphocytic leukemia. [2021]