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

NCT ID: NCT02520102

Last Updated: 2017-04-20

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-28
• Study Completion Date: 2017-02-28

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.

Conditions

Acute Myeloid Leukemia NOS

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

sargramostim

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.

Group Type: EXPERIMENTAL

sargramostim GZ402664

Intervention Type: DRUG

Pharmaceutical form: lyophilized powder in vial

Route of administration: subcutaneous

Interventions

sargramostim GZ402664

Pharmaceutical form: lyophilized powder in vial

Route of administration: subcutaneous

Intervention Type: DRUG

Other Intervention Names

Leukine

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.

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Other Identifiers

U1111-1148-1183

Identifier Type: OTHER

Identifier Source: secondary_id

LTS13932

Identifier Type: -

Identifier Source: org_study_id