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 |
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.
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.
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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