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

• Status: Withdrawn
• Trial end date: 2017-02-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Sargramostim

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.