Acute Myeloid Leukemia NOSPhase 2NCT02520102
Open Label Study of Sargramostim Among Patients Receiving Myelosuppressive Induction Chemotherapy for Acute Myelogenous Leukemia
A Phase 2 study testing sargramostim GZ402664 in people with Acute Myeloid Leukemia NOS, run by Sanofi.
Trial summary
Primary Objective: Measure the proportion of patients who develop binding and neutralizing antibodies in the blood after treatment with sargramostim following induction/reinduction chemotherapy. Read more about this study
- Who is it for?
- Ages 55 to 70 years
- Conditions the study is for
- Acute Myeloid Leukemia NOS
- What is being tested?
- sargramostim GZ402664
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Feb 2017to 28 Feb 2017
- Phase
- Phase 2
- 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 55 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to provide informed consent.
- Newly diagnosed acute myeloid leukemia (AML) to be treated with standard of care induction chemotherapy as per local policy.
- Patients 55 to 70 years of age (inclusive).
- Negative serum pregnancy test within 30 days prior to receiving the first dose of induction chemotherapy in female participants who are <2 years postmenopausal or who are of childbearing potential and have agreed to begin or continue using an adequate method of contraception.
Who cannot join
- Prior treatment with sargramostim or any leukocyte growth factor (LGF) product.
- Prior myelodysplastic syndrome (MDS).
- Known central nervous system (CNS) leukemic involvement diagnosed by cytologic findings in cerebrospinal fluid and/or by computed tomography (CT) or magnetic resonance imaging (MRI).
- Out of range (>2x normal) laboratory values.
- Clinically important medical conditions unrelated to AML as determined by the Investigator.
- Eastern Cooperative Oncology Group (ECOG) performance status >2.
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- Bone marrow blasts ≥5% on marrow examination following induction or reinduction chemotherapy.
- History of allergy to yeast products, recombinant human granulocyte/macrophage-colony-stimulating factor, or any component of sargramostim.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
About this study
Official title: A Phase II Open Label Study of Sargramostim Among Patients Receiving Myelosuppressive Induction Chemotherapy for Acute Myelogenous Leukemia
Primary Objective:
Measure the proportion of patients who develop binding and neutralizing antibodies in the blood after treatment with sargramostim following induction/reinduction chemotherapy.
Secondary Objectives:
- Assess the time after treatment at which the antibodies develop and the level of antibodies is measured after the first dose.
- Measure the levels of immunoglobulin protein.
- Assess the impact of any immune response on safety and the duration of low white blood cell count.
Read the detailed description
The total study duration for a participant is up to 6 months from 1st dose of sargramostim or until the antibodies level return to baseline or up to 24 months if antibodies test is positive at month 6.
- Conditions
- Acute Myeloid Leukemia NOS
- Being tested
- sargramostim GZ402664
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sargramostim GZ402664Drug
Also called Leukine
Pharmaceutical form: lyophilized powder in vial
Route of administration: subcutaneous
| Study group | Role | What they receive |
|---|---|---|
| sargramostim | Experimental | Sargramostim is administered daily until the absolute neutrophil count (ANC) equals or exceeds 1500/mm^3 for 3 consecutive measurements or up to 42 days post-induction chemotherapy. Receives: Drug: sargramostim GZ402664 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who develop antibodies (binding antibodies and neutralizing antibodies)
Measured: 1 month after 1st dose of sargramostim
Proportion of patients who develop antibodies (binding antibodies and neutralizing antibodies)
Measured: 2 months after 1st dose of sargramostim
Proportion of patients who develop antibodies (binding antibodies and neutralizing antibodies)
Measured: 3 months after 1st dose of sargramostim
Proportion of patients who develop antibodies (binding antibodies and neutralizing antibodies)
Measured: 6 months after 1st dose of sargramostim. If positive at month 6, this will be continued every 6 months until the values return to baseline or up to 24 months
Secondary outcomes (10)
Assessment of antibodies (antibody detection and antibody titers)
Measured: 1 month after 1st dose of sargramostim
Assessment of antibodies (antibody detection and antibody titers)
Measured: 2 months after 1st dose of sargramostim
Assessment of antibodies (antibody detection and antibody titers)
Measured: 3 months after 1st dose of sargramostim
Assessment of antibodies (antibody detection and antibody titers)
Measured: 6 months after 1st dose of sargramostim. If positive at month 6, this will be continued every 6 months until the values return to baseline up to 24 months
Assessment of immunoglobulin levels
Measured: 1 month after 1st dose of sargramostim
Assessment of immunoglobulin levels
Measured: 2 months after 1st dose of sargramostim
Assessment of immunoglobulin levels
Measured: 3 months after 1st dose of sargramostim
Assessment of immunoglobulin levels
Measured: 6 months after 1st dose of sargramostim. If antibodies are positive at month 6, the level of immunoglubolins will be assesed every 6 months until the antibodies level return to baseline or up to 24 months
Proportion of patients with adverse events
Measured: Up to 24 months
Duration of neutropenia (time from initiation of sargramostim to recovery of ANC to ≥1500/mm^3)
Measured: Up to 42 days after first day of sargramostim administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2015 (estimated)
- Study startFeb 2017 (estimated)
- Primary completion28 Feb 2017
- Study completion28 Feb 2017
Why it stopped: Company has fulfilled post-marketing requirements
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid Leukemia NOSStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02520102
- Sponsor's protocol ID
- LTS13932
- Other IDs
- U1111-1148-1183
- Status last verified
- Mar 2017
- First submitted
- 7 Aug 2015
- Last updated
- 20 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Open Label Study of Sargramostim Among Patients Receiving Myelosuppressive Induction Chemotherapy for Acute Myelogenous Leukemia
- ClinicalTrials.gov ID
- NCT02520102
- Acronym / sponsor ID
- LTS13932
- Conditions
- Acute Myeloid Leukemia NOS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Company has fulfilled post-marketing requirements
- Enrolment
- 0 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Feb 2017 (estimated)
- Primary completion
- 28 Feb 2017 (actual)
- Study completion
- 28 Feb 2017 (actual)
- First posted
- 11 Aug 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.
Primary Objective:
Measure the proportion of patients who develop binding and neutralizing antibodies in the blood after treatment with sargramostim following induction/reinduction chemotherapy.
Secondary Objectives:
- Assess the time after treatment at which the antibodies develop and the level of antibodies is measured after the first dose.
- Measure the levels of immunoglobulin protein.
- Assess the impact of any immune response on safety and the duration of low white blood cell count.
Detailed description
The total study duration for a participant is up to 6 months from 1st dose of sargramostim or until the antibodies level return to baseline or up to 24 months if antibodies test is positive at month 6.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sargramostim | Experimental | Drug: sargramostim GZ402664Sargramostim is administered daily until the absolute neutrophil count (ANC) equals or exceeds 1500/mm^3 for 3 consecutive measurements or up to 42 days post-induction chemotherapy. |
Who may qualify
- Ages
- 55 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Able to provide informed consent.
- Newly diagnosed acute myeloid leukemia (AML) to be treated with standard of care induction chemotherapy as per local policy.
- Patients 55 to 70 years of age (inclusive).
- Negative serum pregnancy test within 30 days prior to receiving the first dose of induction chemotherapy in female participants who are <2 years postmenopausal or who are of childbearing potential and have agreed to begin or continue using an adequate method of contraception.
Key exclusion criteria (9 listed)
- Prior treatment with sargramostim or any leukocyte growth factor (LGF) product.
- Prior myelodysplastic syndrome (MDS).
- Known central nervous system (CNS) leukemic involvement diagnosed by cytologic findings in cerebrospinal fluid and/or by computed tomography (CT) or magnetic resonance imaging (MRI).
- Out of range (>2x normal) laboratory values.
- Clinically important medical conditions unrelated to AML as determined by the Investigator.
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 |
|---|---|---|
| sargramostim GZ402664Also: LeukinePharmaceutical form: lyophilized powder in vial Route of administration: subcutaneous | Drug | sargramostim |
Primary outcome
Proportion of patients who develop antibodies (binding antibodies and neutralizing antibodies)
Time frame: 1 month after 1st dose of sargramostim
Proportion of patients who develop antibodies (binding antibodies and neutralizing antibodies)
Time frame: 2 months after 1st dose of sargramostim
Proportion of patients who develop antibodies (binding antibodies and neutralizing antibodies)
Time frame: 3 months after 1st dose of sargramostim
Proportion of patients who develop antibodies (binding antibodies and neutralizing antibodies)
Time frame: 6 months after 1st dose of sargramostim. If positive at month 6, this will be continued every 6 months until the values return to baseline or up to 24 months
10 secondary outcomes
Assessment of antibodies (antibody detection and antibody titers)
Time frame: 1 month after 1st dose of sargramostim
Assessment of antibodies (antibody detection and antibody titers)
Time frame: 2 months after 1st dose of sargramostim
Assessment of antibodies (antibody detection and antibody titers)
Time frame: 3 months after 1st dose of sargramostim
Assessment of antibodies (antibody detection and antibody titers)
Time frame: 6 months after 1st dose of sargramostim. If positive at month 6, this will be continued every 6 months until the values return to baseline up to 24 months
Assessment of immunoglobulin levels
Time frame: 1 month after 1st dose of sargramostim
Assessment of immunoglobulin levels
Time frame: 2 months after 1st dose of sargramostim
Assessment of immunoglobulin levels
Time frame: 3 months after 1st dose of sargramostim
Assessment of immunoglobulin levels
Time frame: 6 months after 1st dose of sargramostim. If antibodies are positive at month 6, the level of immunoglubolins will be assesed every 6 months until the antibodies level return to baseline or up to 24 months
Proportion of patients with adverse events
Time frame: Up to 24 months
Duration of neutropenia (time from initiation of sargramostim to recovery of ANC to ≥1500/mm^3)
Time frame: Up to 42 days after first day of sargramostim administration
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2017.
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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.
Clinical Sciences & Operations study director
Sanofi
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing sargramostim GZ402664 in people with Acute Myeloid Leukemia NOS, run by Sanofi.
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 4 inclusion and 9 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: withdrawn, as of the sponsor's last update on 20 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was withdrawn before enrolling participants, so there are no results.
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?
Proportion of patients who develop antibodies (binding antibodies and neutralizing antibodies) (time frame: 1 month after 1st dose of sargramostim). The study lists 4 primary outcomes in all. 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 20 Apr 2017.