Study of Lenzilumab in Previously Treated Patients With Chronic Myelomonocytic Leukemia (CMML)

Chronic Myelomonocytic Leukemia (CMML) Clinical Trial

Official title:

A Phase 1 Study of Lenzilumab in Subjects With Previously Treated Chronic Myelomonocytic Leukemia (CMML)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02546284
• Other study ID #: HGEN003-05
• Status: Completed
• Phase: Phase 1
• Start date: July 2016
• Est. completion date: February 2020

Study information

• Verified date: February 2020
• Source: Humanigen, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a multicenter, open-label, repeat-dose, Phase 1 Dose Escalation Study to evaluate safety, pharmacokinetics, and clinical activity.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: February 2020
• Est. primary completion date: February 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Myelomonocytic Leukemia (CMML)
• Leukemia
• Leukemia, Myelomonocytic, Acute
• Leukemia, Myelomonocytic, Chronic
• Leukemia, Myelomonocytic, Juvenile

Intervention

Drug:
• lenzilumab

Locations

Country	Name	City	State
United States	Mayo Clinic Cancer Center Clinical Research	Rochester	Minnesota
United States	Moffitt Cancer Center	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Humanigen, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Maximum plasma concentration (Cmax) of lenzilumab		At end of infusion or 1 hour after end of infusion on Day 1
Other	Time to maximum plasma concentration (Tmax) of lenzilumab		Pre-dose to end of infusion or 1 hour after end of infusion on Day 1
Other	Minimum plasma concentration (Cmin) of lenzilumab		At Day 15
Other	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
Other	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
Other	Plasma clearance (CL) of lenzilumab		End of infusion, 1 hour after end of infusion on Day 1, Day 2, Day 7, Day 15
Other	lenzilumab immunogenicity (as measured by antibodies against lenzilumab in blood)		Up to an average of 12 months
Primary	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	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