Ofatumumab + HDMP + Lenalidomide for Chronic Lymphocytic Leukemia

Recruiting in Palo Alto (17 mi)

Overseen byCeleste Bello, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

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.

Eligibility Criteria

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

+9 more

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

+13 more

Participant Groups

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.

1Treatment groups

Experimental Treatment

Group I: ImmunotherapyExperimental Treatment3 Interventions

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