Chronic Myelomonocytic Leukemia (CMML)
Conditions
Keywords
CMML
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.
Interventions
DRUGlenzilumab
Sponsors
Humanigen, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Other
| Measure | Time frame |
|---|---|
| Minimum plasma concentration (Cmin) of lenzilumab | At Day 15 |
| Area under the plasma concentration curve (AUC) of lenzilumab | Predose, end of infusion, 1 hour after end of infusion on Day 1, Day 2, Day 7, Day 15 |
| Maximum plasma concentration (Cmax) of lenzilumab | At end of infusion or 1 hour after end of infusion on Day 1 |
| Plasma clearance (CL) of lenzilumab | End of infusion, 1 hour after end of infusion on Day 1, Day 2, Day 7, Day 15 |
| lenzilumab immunogenicity (as measured by antibodies against lenzilumab in blood) | Up to an average of 12 months |
| Plasma half life (t ½) of lenzilumab | End of infusion, 1 hour after end of infusion on Day 1, Day 2, Day 7, Day 15 |
| Time to maximum plasma concentration (Tmax) of lenzilumab | Pre-dose to end of infusion or 1 hour after end of infusion on Day 1 |
Countries
United States
Outcome results
None listed