Study of Lenzilumab in Previously Treated Patients With Chronic Myelomonocytic Leukemia (CMML)

Study Overview
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Brief Summary
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This is a multicenter, open-label, repeat-dose, Phase 1 Dose Escalation Study to evaluate safety, pharmacokinetics, and clinical activity.

Detailed Description
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The purpose of the study is to examine the safety and determine the recommended Phase 2 dose of lenzilumab when administered to subjects with previously treated CMML who meet the entry criteria. Study will begin enrollment in July 2016.

Official Title
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A Phase 1 Study of Lenzilumab in Subjects With Previously Treated Chronic Myelomonocytic Leukemia (CMML)

Conditions
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Chronic Myelomonocytic Leukemia (CMML)

Intervention / Treatment
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* Drug: lenzilumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed diagnosis of CMML CMML that is refractory to, or progressed following treatment with a hypomethylating agent or other standard of care treatment Eastern Cooperative Oncology Group (ECOG) score ≤ 2 Able to provide bone marrow biopsy samples Acceptable laboratory results Exclusion Criteria: Leukemia other than CMML Recent chemotherapy or radiation therapy (within 14 days before first dose of lenzilumab) Concurrent use of human granulocyte-macrophage colony-stimulating factor Pregnant or breastfeeding Know HIV virus infection History of another malignancy within the past 2 years (some skin cancer and prostate cancers permitted) Significant intercurrent illness History or current diagnosis of Pulmonary Alveolar Proteinosis or Hypoxemia

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Agent lenzilumab<br>Dose levels: lenzilumab IV infusion once monthly for a 28 day dosing cycle (with extra dose on Day 15 during cycle). Three (3) to Six (6) subjects will be enrolled into planned escalating cohorts of 200 mg, 400 mg or 600 mg lenzilumab. | Drug: lenzilumab<br> <br> * Other names: Monoclonal Antibody;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of lenzilumab (as measured by the number of participants with adverse events) at various doses in order to determine a recommended Phase 2 dose |  | Up to an average of 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical activity of lenzilumab (as measured by changes in spleen size, blood and bone marrow measurements of disease, clinical symptoms, etc) |  | Up to an average of 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CMML