Back to resultsStudy of Lenzilumab in Previously Treated Patients With Chronic Myelomonocytic Leukemia (CMML)
Primary Purpose
Chronic Myelomonocytic Leukemia (CMML)
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
lenzilumab
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Myelomonocytic Leukemia (CMML) focused on measuring CMML
Eligibility Criteria
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
Sites / Locations
- Moffitt Cancer Center
- Mayo Clinic Cancer Center Clinical Research
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single Agent lenzilumab
Arm Description
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Clinical activity of lenzilumab (as measured by changes in spleen size, blood and bone marrow measurements of disease, clinical symptoms, etc)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02546284
Brief Title
Study of Lenzilumab in Previously Treated Patients With Chronic Myelomonocytic Leukemia (CMML)
Official Title
A Phase 1 Study of Lenzilumab in Subjects With Previously Treated Chronic Myelomonocytic Leukemia (CMML)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
July 2016 (undefined)
Primary Completion Date
February 2020 (Actual)
Study Completion Date
February 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Humanigen, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a multicenter, open-label, repeat-dose, Phase 1 Dose Escalation Study to evaluate safety, pharmacokinetics, and clinical activity.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Myelomonocytic Leukemia (CMML)
Keywords
CMML
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single Agent lenzilumab
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
lenzilumab
Other Intervention Name(s)
Monoclonal Antibody
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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
Other Pre-specified Outcome Measures:
Title
Maximum plasma concentration (Cmax) of lenzilumab
Time Frame
At end of infusion or 1 hour after end of infusion on Day 1
Title
Time to maximum plasma concentration (Tmax) of lenzilumab
Time Frame
Pre-dose to end of infusion or 1 hour after end of infusion on Day 1
Title
Minimum plasma concentration (Cmin) of lenzilumab
Time Frame
At Day 15
Title
Area under the plasma concentration curve (AUC) of lenzilumab
Time Frame
Predose, end of infusion, 1 hour after end of infusion on Day 1, Day 2, Day 7, Day 15
Title
Plasma half life (t ½) of lenzilumab
Time Frame
End of infusion, 1 hour after end of infusion on Day 1, Day 2, Day 7, Day 15
Title
Plasma clearance (CL) of lenzilumab
Time Frame
End of infusion, 1 hour after end of infusion on Day 1, Day 2, Day 7, Day 15
Title
lenzilumab immunogenicity (as measured by antibodies against lenzilumab in blood)
Time Frame
Up to an average of 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Mayo Clinic Cancer Center Clinical Research
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study of Lenzilumab in Previously Treated Patients With Chronic Myelomonocytic Leukemia (CMML)
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