Clinical trial · Interventional
Study of Lenzilumab in Previously Treated Patients With Chronic Myelomonocytic Leukemia (CMML)
A Phase 1 Study of Lenzilumab in Subjects With Previously Treated Chronic Myelomonocytic Leukemia (CMML)
NCT02546284CI-TRIAL-00043702completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a multicenter, open-label, repeat-dose, Phase 1 Dose Escalation Study to evaluate safety, pharmacokinetics, and clinical activity.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Myelomonocytic Leukemia (CMML) | Chronic Myelomonocytic Leukemia | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| lenzilumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single Agent lenzilumab
- description
- 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.
- interventionNames
- Drug: lenzilumab
Primary outcomes (1)
- measure
- 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
- timeFrame
- Up to an average of 12 months
Secondary outcomes (1)
- measure
- Clinical activity of lenzilumab (as measured by changes in spleen size, blood and bone marrow measurements of disease, clinical symptoms, etc)
- timeFrame
- Up to an average of 12 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.