Ofatumumab + HDMP + Lenalidomide for Chronic Lymphocytic Leukemia

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Must be taking: Aspirin

Must not be taking: Thalidomide

Disqualifiers: Pregnancy, HIV, Hepatitis B, 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: Unknown

Duration: 3 months

45 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The main purpose of this study is to see if ofatumumab with methylprednisolone followed by additional treatment with ofatumumab and lenalidomide can help people with Chronic Lymphocytic Leukemia (CLL) get rid of their CLL for a long period of time. Researchers also want to find out if the combination of ofatumumab with methylprednisolone followed by additional treatment with ofatumumab and lenalidomide is safe and tolerable.

Who Is on the Research Team?

Celeste Bello, M.D.

Principal Investigator

H. Lee Moffitt Cancer Center and Research Institute

Are You a Good Fit for This Trial?

This trial is for adults with untreated Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL), who have not had other cancers in the last 5 years, except certain skin or 'in situ' cancers. Participants must meet specific disease criteria, be physically able to follow the study plan, and women of childbearing age must use two forms of birth control due to risks from one of the drugs.

Inclusion Criteria

Understand and voluntarily sign an informed consent form

Able to adhere to the study visit schedule and other protocol requirements

Laboratory test results within specified ranges

Exclusion Criteria

Pregnant or breast feeding females

Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form

Any condition that places the patient at unacceptable risk or confounds data interpretation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Ofatumumab with high dose Methylprednisolone followed by Ofatumumab and Lenalidomide

3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

36 months

Long-term Follow-up

Participants are monitored for progression-free survival and overall survival

Up to 56 months

What Are the Treatments Tested in This Trial?

Interventions

• High Dose Methylprednisolone
• Lenalidomide
• Ofatumumab

Trial Overview Researchers are testing a combination therapy for CLL/SLL that starts with Ofatumumab and high-dose Methylprednisolone, followed by additional treatment with Ofatumumab and Lenalidomide. The goal is to see if this regimen can effectively eliminate leukemia cells and maintain remission over time while also being safe for patients.

How Is the Trial Designed?

Group I: Immunotherapy Experimental Treatment 3 Interventions

Combination Regimen Followed by Consolidative Therapy: Ofatumumab/High Dose Methylprednisolone (HDMP) plus Ofatumumab/Lenalidomide

Who Is Running the Clinical Trial?

H. Lee Moffitt Cancer Center and Research Institute

Lead Sponsor

Trials

576

Recruited

145,000+

Novartis

Industry Sponsor

Trials

1,646

Recruited

2,778,000+

Vasant Narasimhan

Novartis

Chief Executive Officer since 2018

MD from Harvard Medical School, Bachelor's in Biological Sciences from University of Chicago, Master's in Public Policy from John F. Kennedy School of Government

Shreeram Aradhye

Novartis

Chief Medical Officer since 2022

MD from Yale University, MSc in Clinical Epidemiology from University of Pennsylvania

Celgene Corporation

Industry Sponsor

Trials

446

Recruited

58,500+

Mark Alles

Celgene Corporation

Chief Executive Officer since 2016

Bachelor's degree from Lock Haven University of Pennsylvania

Sol J. Barer

Celgene Corporation

Chief Medical Officer since 2006

PhD in Organic and Physical Chemistry from Rutgers University