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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Acute Myeloid Leukemia NOS
• Intervention / Treatment: Drug: sargramostim GZ402664

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.

• Study Type: Interventional
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 51 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: sargramostim GZ402664; Pharmaceutical form: lyophilized powder in vial Route of administration: subcutaneous; Other Names: Leukine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients who develop antibodies (binding antibodies and neutralizing antibodies)	1 month after 1st dose of sargramostim
Proportion of patients who develop antibodies (binding antibodies and neutralizing antibodies)	2 months after 1st dose of sargramostim
Proportion of patients who develop antibodies (binding antibodies and neutralizing antibodies)	3 months after 1st dose of sargramostim
Proportion of patients who develop antibodies (binding antibodies and neutralizing antibodies)	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 Outcome Measures

Outcome Measure	Time Frame
Assessment of antibodies (antibody detection and antibody titers)	1 month after 1st dose of sargramostim
Assessment of antibodies (antibody detection and antibody titers)	2 months after 1st dose of sargramostim
Assessment of antibodies (antibody detection and antibody titers)	3 months after 1st dose of sargramostim
Assessment of antibodies (antibody detection and antibody titers)	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
Assessment of immunoglobulin levels	1 month after 1st dose of sargramostim
Assessment of immunoglobulin levels	2 months after 1st dose of sargramostim
Assessment of immunoglobulin levels	3 months after 1st dose of sargramostim
Assessment of immunoglobulin levels	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
Proportion of patients with adverse events	Up to 24 months
Duration of neutropenia (time from initiation of sargramostim to recovery of ANC to ≥1500/mm^3)	Up to 42 days after first day of sargramostim administration

Collaborators and Investigators

• Sponsor: Sanofi

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2017
• Primary Completion (Actual): February 28, 2017
• Study Completion (Actual): February 28, 2017

Study Registration Dates

• First Submitted: August 7, 2015
• First Submitted That Met QC Criteria: August 7, 2015
• First Posted (Estimate): August 11, 2015

Study Record Updates

• Last Update Posted (Actual): April 20, 2017
• Last Update Submitted That Met QC Criteria: April 19, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Physiological Effects of Drugs; Immunologic Factors; Sargramostim
• Other Study ID Numbers: LTS13932; U1111-1148-1183 (Other Identifier: UTN)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No