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Open Label Study of Sargramostim Among Patients Receiving Myelosuppressive Induction Chemotherapy for Acute Myelogenous Leukemia

NCT02520102

WithdrawnPhase 2

Sponsor: Sanofi

Conditions: Acute Myeloid Leukemia NOS

Interventions: sargramostim GZ402664

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.

Eligibility overview

Sex: ALL

Age: 55 Years to 70 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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.