Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Agent lenzilumab | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lenzilumab | Drug |
|
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration (Cmax) of lenzilumab | At end of infusion or 1 hour after end of infusion on Day 1 | |
| Time to maximum plasma concentration (Tmax) of lenzilumab | Pre-dose to end of infusion or 1 hour after end of infusion on Day 1 |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moffitt Cancer Center | Tampa | Florida | 33612 | United States | ||
| Mayo Clinic Cancer Center Clinical Research |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D015477 | Leukemia, Myelomonocytic, Chronic |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000710968 | lenzilumab |
| D000911 | Antibodies, Monoclonal |
| ID | Term |
|---|---|
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| 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 |
| 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 |
| Rochester |
| Minnesota |
| 55905 |
| United States |
| D054437 |
| Myelodysplastic-Myeloproliferative Diseases |
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011506 |
| Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |