45 Participants Needed

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
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

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.

Research Team

CB

Celeste Bello, M.D.

Principal Investigator

H. Lee Moffitt Cancer Center and Research Institute

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
See 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
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Treatment Details

Interventions

  • High Dose Methylprednisolone
  • Lenalidomide
  • Ofatumumab
Trial OverviewResearchers 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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: ImmunotherapyExperimental Treatment3 Interventions
Combination Regimen Followed by Consolidative Therapy: Ofatumumab/High Dose Methylprednisolone (HDMP) plus Ofatumumab/Lenalidomide

Find a Clinic Near You

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 profile image

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 profile image

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 profile image

Mark Alles

Celgene Corporation

Chief Executive Officer since 2016

Bachelor's degree from Lock Haven University of Pennsylvania

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Sol J. Barer

Celgene Corporation

Chief Medical Officer since 2006

PhD in Organic and Physical Chemistry from Rutgers University