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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02546284
Recruitment Status : Completed
First Posted : September 10, 2015
Last Update Posted : February 28, 2020
Sponsor:
Information provided by (Responsible Party):
Humanigen, Inc.

Study Description
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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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
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
Actual Primary Completion Date : February 2020
Actual Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia

Arms and Interventions
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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


Outcome Measures
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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 ]

Eligibility Criteria
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Information from the National Library of Medicine

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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
Contacts and Locations
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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


Locations
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United States, Florida
Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, Minnesota
Mayo Clinic Cancer Center Clinical Research
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Humanigen, Inc.
More Information
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Responsible Party: Humanigen, Inc.
ClinicalTrials.gov Identifier: NCT02546284    
Other Study ID Numbers: HGEN003-05
First Posted: September 10, 2015    Key Record Dates
Last Update Posted: February 28, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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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
Chronic Disease
Disease Attributes
Pathologic Processes
Lenzilumab
Anti-Inflammatory Agents