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

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ClinicalTrials.gov Identifier: NCT02546284
Recruitment Status : Recruiting
First Posted : September 10, 2015
Last Update Posted : March 15, 2018
Sponsor:
Information provided by (Responsible Party):
Humanigen, Inc.

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

Condition or disease Intervention/treatment Phase
Chronic Myelomonocytic Leukemia (CMML) Drug: lenzilumab Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study of Lenzilumab in Subjects With Previously Treated Chronic Myelomonocytic Leukemia (CMML)
Study Start Date : July 2016
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : October 2018


Arm Intervention/treatment
Experimental: Single Agent lenzilumab
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.
Drug: lenzilumab
Other Name: Monoclonal Antibody




Primary Outcome Measures :
  1. 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 Measures :
  1. 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 Outcome Measures:
  1. Maximum plasma concentration (Cmax) of lenzilumab [ Time Frame: At end of infusion or 1 hour after end of infusion on Day 1 ]
  2. 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 ]
  3. Minimum plasma concentration (Cmin) of lenzilumab [ Time Frame: At Day 15 ]
  4. 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 ]
  5. 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 ]
  6. 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 ]
  7. lenzilumab immunogenicity (as measured by antibodies against lenzilumab in blood) [ Time Frame: Up to an average of 12 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02546284


Contacts
Contact: Adrian Lo 650-243-3182 alo@humanigen.com

Locations
United States, Florida
Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Contact: Mariel Escobar, BS    813-745-7362    Mariel.Escobar@moffitt.org   
Principal Investigator: David Sallman, MD         
United States, Minnesota
Mayo Clinic Cancer Center Clinical Research Recruiting
Rochester, Minnesota, United States, 55905
Contact: Jeffrey Hirvela, BS    507-538-4212    hirvela.jeffrey@mayo.edu   
Principal Investigator: Mrinal Patnaik, MBBS         
Sponsors and Collaborators
Humanigen, Inc.

Responsible Party: Humanigen, Inc.
ClinicalTrials.gov Identifier: NCT02546284     History of Changes
Other Study ID Numbers: HGEN003-05
First Posted: September 10, 2015    Key Record Dates
Last Update Posted: March 15, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Humanigen, Inc.:
CMML

Additional relevant MeSH terms:
Leukemia
Leukemia, Myelomonocytic, Acute
Leukemia, Myelomonocytic, Chronic
Leukemia, Myelomonocytic, Juvenile
Neoplasms by Histologic Type
Neoplasms
Leukemia, Myeloid
Myelodysplastic-Myeloproliferative Diseases
Bone Marrow Diseases
Hematologic Diseases