Chronic Myelomonocytic Leukemia (CMML)Phase 1NCT02546284
Study of Lenzilumab in Previously Treated Patients With Chronic Myelomonocytic Leukemia (CMML)
A Phase 1 study testing lenzilumab in people with Chronic Myelomonocytic Leukemia (CMML), run by Humanigen, Inc. at 2 sites in United States.
Trial summary
This is a multicenter, open-label, repeat-dose, Phase 1 Dose Escalation Study to evaluate safety, pharmacokinetics, and clinical activity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Myelomonocytic Leukemia (CMML)
- What is being tested?
- lenzilumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2016to Feb 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mayo Clinic Cancer Center Clinical Research
Rochester, Minnesota, 55905
Moffitt Cancer Center
Tampa, Florida, 33612
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Myelomonocytic Leukemia (CMML)
- Being tested
- lenzilumab
- Keywords
- CMML
- Medical subject headings
- Leukemia, Myelomonocytic, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lenzilumabDrug
Also called Monoclonal Antibody
| Study group | Role | What they receive |
|---|---|---|
| Single Agent lenzilumab | Experimental | 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. Receives: Drug: lenzilumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: Up to an average of 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2015 (estimated)
- Study startJul 2016
- Primary completionFeb 2020
- Study completionFeb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Myelomonocytic Leukemia (CMML)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Humanigen, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02546284
- Sponsor's protocol ID
- HGEN003-05
- Status last verified
- Feb 2020
- First submitted
- 27 Aug 2015
- Last updated
- 28 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of Lenzilumab in Subjects With Previously Treated Chronic Myelomonocytic Leukemia (CMML)
- ClinicalTrials.gov ID
- NCT02546284
- Acronym / sponsor ID
- HGEN003-05
- Conditions
- Chronic Myelomonocytic Leukemia (CMML)
- Keywords
- CMML
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Humanigen, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2016
- Primary completion
- Feb 2020 (actual)
- Study completion
- Feb 2020 (actual)
- First posted
- 10 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, open-label, repeat-dose, Phase 1 Dose Escalation Study to evaluate safety, pharmacokinetics, and clinical activity.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Agent lenzilumab | Experimental | Drug: lenzilumabDose 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lenzilumabAlso: Monoclonal Antibody | Drug | Single Agent lenzilumab |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing lenzilumab in people with Chronic Myelomonocytic Leukemia (CMML), run by Humanigen, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: Up to an average of 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2020.