Clinical trial NCT02546284: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Myelomonocytic Leukemia (CMML)
Keywords: CMML
Lead sponsor: Humanigen, Inc.
Sponsor class: INDUSTRY
First posted: 2015-09-10
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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
timeFrame: Up to an average of 12 months
Secondary outcomes:
measure: Clinical activity of lenzilumab (as measured by changes in spleen size, blood and bone marrow measurements of disease, clinical symptoms, etc)
timeFrame: Up to an average of 12 months
Other outcomes:
measure: Maximum plasma concentration (Cmax) of lenzilumab
timeFrame: At end of infusion or 1 hour after end of infusion on Day 1
measure: Time to maximum plasma concentration (Tmax) of lenzilumab
timeFrame: Pre-dose to end of infusion or 1 hour after end of infusion on Day 1
measure: Minimum plasma concentration (Cmin) of lenzilumab
timeFrame: At Day 15
measure: Area under the plasma concentration curve (AUC) of lenzilumab
timeFrame: Predose, end of infusion, 1 hour after end of infusion on Day 1, Day 2, Day 7, Day 15
measure: Plasma half life (t ½) of lenzilumab
timeFrame: End of infusion, 1 hour after end of infusion on Day 1, Day 2, Day 7, Day 15
measure: Plasma clearance (CL) of lenzilumab
timeFrame: End of infusion, 1 hour after end of infusion on Day 1, Day 2, Day 7, Day 15
measure: lenzilumab immunogenicity (as measured by antibodies against lenzilumab in blood)
timeFrame: Up to an average of 12 months
Locations:
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Rochester
country: United States
facility: Mayo Clinic Cancer Center Clinical Research
state: Minnesota
Study officials:
References: