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

Humanigen, Inc.15 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Myelomonocytic Leukemia (CMML)

Interventions

lenzilumabDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Moffitt Cancer Center

Tampa, Florida, United States

Mayo Clinic Cancer Center Clinical Research

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

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

Time frame: Up to an average of 12 months

Secondary Outcomes

Clinical activity of lenzilumab (as measured by changes in spleen size, blood and bone marrow measurements of disease, clinical symptoms, etc)

Time frame: Up to an average of 12 months

Data from ClinicalTrials.gov

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