Clinical trial NCT02520102: Open Label Study of Sargramostim Among Patients Receiving Myelosuppressive Induction Chemotherapy for Acute Myelogenous Leukemia
Official title: A Phase II Open Label Study of Sargramostim Among Patients Receiving Myelosuppressive Induction Chemotherapy for Acute Myelogenous Leukemia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Acute Myeloid Leukemia NOS
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2015-08-11
Enrollment: 0
Sex: ALL
Minimum age (years): 55
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion criteria :

* 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.

Exclusion criteria:

* 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.
* 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.

Primary outcomes:
measure: Proportion of patients who develop antibodies (binding antibodies and neutralizing antibodies)
timeFrame: 1 month after 1st dose of sargramostim
measure: Proportion of patients who develop antibodies (binding antibodies and neutralizing antibodies)
timeFrame: 2 months after 1st dose of sargramostim
measure: Proportion of patients who develop antibodies (binding antibodies and neutralizing antibodies)
timeFrame: 3 months after 1st dose of sargramostim
measure: Proportion of patients who develop antibodies (binding antibodies and neutralizing antibodies)
timeFrame: 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:
measure: Assessment of antibodies (antibody detection and antibody titers)
timeFrame: 1 month after 1st dose of sargramostim
measure: Assessment of antibodies (antibody detection and antibody titers)
timeFrame: 2 months after 1st dose of sargramostim
measure: Assessment of antibodies (antibody detection and antibody titers)
timeFrame: 3 months after 1st dose of sargramostim
measure: Assessment of antibodies (antibody detection and antibody titers)
timeFrame: 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
measure: Assessment of immunoglobulin levels
timeFrame: 1 month after 1st dose of sargramostim
measure: Assessment of immunoglobulin levels
timeFrame: 2 months after 1st dose of sargramostim
measure: Assessment of immunoglobulin levels
timeFrame: 3 months after 1st dose of sargramostim
measure: Assessment of immunoglobulin levels
timeFrame: 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
measure: Proportion of patients with adverse events
timeFrame: Up to 24 months
measure: Duration of neutropenia (time from initiation of sargramostim to recovery of ANC to ≥1500/mm^3)
timeFrame: Up to 42 days after first day of sargramostim administration
Other outcomes:
Locations:
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: