MOR00208 + Lenalidomide for Chronic Lymphocytic Leukemia

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Ohio State University Comprehensive Cancer Center

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: 12

Duration: 12 months

41 Participants Needed

Trial Summary

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.

Research Team

Jennifer Woyach, MD

Principal Investigator

The Ohio State University Comprehensive Cancer Center

Eligibility Criteria

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

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

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Cohorts 1-3Treatment (MOR00208, lenalidomide) Experimental Treatment 3 Interventions

Patients receive anti-CD19 monoclonal antibody MOR00208 IV over 2 hours on day 1 (days 1, 2, 8, 15, and 22 of course 1 only) and lenalidomide PO daily on days 1-28 (days 9-28 of course 1 only). Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Correlative studies will be collected for this trial and will focus on the effects of MOR00208 alone and in combination with lenalidomide on immune effector cell number and function.

Group II: Cohort 4 Treatment (MOR00208, ibrutinib) Experimental Treatment 2 Interventions

Patients receive anti-CD19 monoclonal antibody MOR00208 IV over 2 hours on day 1 (days 1, 2, 8, 15, and 22 of course 1 only) and ibrutinib PO daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Correlative studies will be collected for this trial and will focus on the effects of MOR00208 alone and in combination with ibrutinib on immune effector cell number and function.

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

Approved in European Union as Revlimid for:

• Multiple myeloma
• Myelodysplastic syndromes
• Mantle cell lymphoma
• Follicular lymphoma
• Marginal zone lymphoma

Approved in United States as Revlimid for:

• Multiple myeloma
• Myelodysplastic syndromes
• Mantle cell lymphoma
• Follicular lymphoma
• Marginal zone lymphoma

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+