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

Sanofi

Status and phase: Withdrawn; Phase 2

Conditions: Acute Myeloid Leukemia NOS

Treatments: Drug: sargramostim GZ402664

Study type: Interventional

Funder types: Industry

Identifiers

NCT02520102

U1111-1148-1183 (Other Identifier)

LTS13932

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 55 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

sargramostim

Experimental group

Description:

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.

Treatment:

Drug: sargramostim GZ402664