NCT02005289

Phase II MOR00208 in Combination With Lenalidomide for Patients With Relapsed or Refractory CLL, SLL or PLL or Older Patients With Untreated CLL, SLL or PLL

A Phase II Study of MOR00208 in Combination With Lenalidomide for Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia(CLL)/Small Lymphocytic Lymphoma (SLL)/Prolymphocytic Leukemia (PLL), Including Those Who Have Relapsed on Ibrutinib, or Patients With Untreated CLL/SLL/PLL and an Open Pilot Study for Patients With Richters Transformation (RT)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Ohio State University Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

PRIMARY OBJECTIVES: I. To determine the overall response rate (ORR) at 6 months for patients with relapsed or refractory chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL)/prolymphocytic leukemia (PLL) treated with the combination of MOR00208 plus lenalidomide. II. To determine the overall response rate (ORR) at 6 months for patients with treatment-naive CLL/SLL/PLL treated with the combination of MOR00208 plus lenalidomide. III.To obtain preliminary data on toxicity profiles and efficacy with the combination of MOR00208 plus lenalidomide in patients with Richter's Transformation IV. To obtain preliminary data on efficacy of MOR00208 in patients with progressive disease on ibrutinib monotherapy SECONDARY OBJECTIVES: I. To determine the overall response rate (ORR) at 12 months for patients with untreated CLL/SLL/PLL or relapsed/refractory disease treated with the combination of MOR00208 plus lenalidomide. II. To determine the complete response (CR) rate, nodular partial response (nPR) rate, partial response (PR) rate, and stable disease (SD) rate for patients with untreated CLL/SLL/PLL or relapsed or refractory disease treated with the combination of MOR00208 plus lenalidomide. III. To summarize the progression free survival (PFS), time to next treatment, and overall survival (OS) for each of two cohorts of patients treated with this regimen. IV. To evaluate toxicity with this regimen, including frequency and severity of toxicities, dose reduction requirements, and adverse events requiring drug discontinuation. V. To perform baseline analysis of patients enrolled on this trial including fluorescence in situ hybridization (FISH), stimulated karyotype, zeta-chain-associated protein kinase 70 (Zap-70) methylation, and immunoglobulin variable region heavy chain (IgVH) mutational status and describe relationships between these biomarkers and ORR or PFS for each of two cohorts with this regimen. VI. To determine the effect of this regimen on total immunoglobulins, CD4+ and CD8+ T cells, natural killer (NK) cells, and interleukin-21 receptor (IL-21R) expression on CLL cells. VII. To determine whether NK cells and T cells are activated in response to MOR00208 alone or in combination with lenalidomide. VIII. To estimate the rate of minimal residual disease (MRD) in patients achieving CR, and whether this correlates with PFS. OUTLINE: Patients receive anti-CD19 monoclonal antibody MOR00208 intravenously (IV) over 2 hours on day 1 (days 1, 2, 8, 15, and 22 of course 1) and lenalidomide orally (PO) daily on days 1-28 (days 9-28 of course 1). Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Conditions

• Contiguous Stage II Small Lymphocytic Lymphoma
• Noncontiguous Stage II Small Lymphocytic Lymphoma
• Prolymphocytic Leukemia
• Recurrent Small Lymphocytic Lymphoma
• Refractory Chronic Lymphocytic Leukemia
• Stage I Chronic Lymphocytic Leukemia
• Stage I Small Lymphocytic Lymphoma
• Stage II Chronic Lymphocytic Leukemia
• Stage III Chronic Lymphocytic Leukemia
• Stage III Small Lymphocytic Lymphoma
• Stage IV Chronic Lymphocytic Leukemia
• Stage IV Small Lymphocytic Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	MOR00208	Given by IV infusion
DRUG	lenalidomide	Given PO
OTHER	Correlative Studies	Correlative studies associated with this trial will focus on the effects of MOR00208 alone and in combination with lenalidomide on immune effector cell number and function.

Timeline

• Start date: 2014-01-17
• Primary completion: 2025-05-20
• Completion: 2025-05-20
• First posted: 2013-12-09
• Last updated: 2025-12-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study