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Completed

NCT Number: NCT02546284

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

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

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Key information

Conditions

Chronic Myelomonocytic Leukemia (CMML) Bone Marrow Diseases Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myelomonocytic, Chronic Myelodysplastic-Myeloproliferative Diseases Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Moffitt Cancer Center, Tampa, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

lenzilumab

Drug

Other names: Monoclonal Antibody

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Humanigen, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Sep 10, 2015
Registry last updated
Feb 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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