41 Participants Needed
Ohio State University Comprehensive Cancer Center logo

MOR00208 + Lenalidomide for Chronic Lymphocytic Leukemia

Recruiting in Columbus (<10 mi)
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Ohio State University Comprehensive Cancer Center
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

What You Need to Know Before You Apply

What is the purpose of this trial?

This phase II trial studies how well anti-cluster of differentiation (CD)19 monoclonal antibody MOR00208 and lenalidomide work in treating patients with relapsed, refractory, or previously untreated chronic lymphocytic leukemia, small lymphocytic lymphoma, or prolymphocytic leukemia. Monoclonal antibodies, such as anti-CD19 monoclonal antibody MOR00208, 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. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Giving anti-CD19 monoclonal antibody MOR00208 and lenalidomide may kill more cancer cells.

Who Is on the Research Team?

JW

Jennifer Woyach, MD

Principal Investigator

The Ohio State University Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with chronic lymphocytic leukemia, small lymphocytic lymphoma, or prolymphocytic leukemia that's come back or hasn't been treated. They should have symptoms like weight loss, fatigue, fever without infection, large spleen or lymph nodes. They need to be in good enough health to take pills and not have other serious illnesses or cancers that would interfere with the study.

Inclusion Criteria

Patients must be able to receive outpatient treatment and follow-up at the treating institution
Patients with a diagnosis of intermediate or high risk CLL, SLL, or B cell (B)-PLL by Biennial International Workshop on CLL (IWCLL) 2008 criteria who have
COHORT 1: previously untreated disease AND refuse or are ineligible for approved chemo- and/or -immunotherapy options for untreated CLL/SLL/PLL
See 23 more

Exclusion Criteria

Previous treatment with a CD19 antibody; prior lenalidomide is acceptable for patients on cohort 2
Patients who have received alemtuzumab within the previous 6 months
Patients with active Richter's transformation
See 11 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive anti-CD19 monoclonal antibody MOR00208 and lenalidomide. Treatment repeats every 28 days for up to 12 courses.

12 months
Monthly visits for 12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Lenalidomide
  • MOR00208
Trial Overview Researchers are testing a combination of MOR00208 (an antibody targeting cancer cells) and lenalidomide (a drug that may boost the immune system) to see if they work better together against certain blood cancers. The trial will look at how well patients respond to this treatment combo.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Cohorts 1-3Treatment (MOR00208, lenalidomide)Experimental Treatment3 Interventions
Group II: Cohort 4 Treatment (MOR00208, ibrutinib)Experimental Treatment2 Interventions

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

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Approved in European Union as Revlimid for:
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Approved in United States as Revlimid for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials
350
Recruited
295,000+

MorphoSys AG

Industry Sponsor

Trials
27
Recruited
6,600+
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