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



Status:Recruiting
Conditions:Blood Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/17/2018
Start Date:July 2016
End Date:October 2018
Contact:Adrian Lo
Email:alo@humanigen.com
Phone:650-243-3182

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

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

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.

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
We found this trial at
2
sites
Rochester, Minnesota 55905
Principal Investigator: Mrinal Patnaik, MBBS
Phone: 507-538-4212
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Tampa, Florida 33612
Principal Investigator: David Sallman, MD
Phone: 813-745-7362
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Tampa, FL
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