Study of Lenzilumab in Previously Treated Patients With Chronic Myelomonocytic Leukemia (CMML)
NCT ID: NCT02546284
Last Updated: 2020-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
15 participants
INTERVENTIONAL
2016-07-31
2020-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Single Agent lenzilumab
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.
lenzilumab
Interventions
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lenzilumab
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Humanigen, Inc.
INDUSTRY
Responsible Party
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Locations
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Moffitt Cancer Center
Tampa, Florida, United States
Mayo Clinic Cancer Center Clinical Research
Rochester, Minnesota, United States
Countries
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Other Identifiers
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HGEN003-05
Identifier Type: -
Identifier Source: org_study_id
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