Back to results

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

Primary Purpose

Acute Myeloid Leukemia NOS

Status

Withdrawn

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

sargramostim GZ402664

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia NOS

Eligibility Criteria

55 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

sargramostim

Arm 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.

Outcomes

Primary Outcome Measures

Proportion of patients who develop antibodies (binding antibodies and neutralizing antibodies)

Secondary Outcome Measures

Assessment of antibodies (antibody detection and antibody titers)

Assessment of immunoglobulin levels

Proportion of patients with adverse events

Duration of neutropenia (time from initiation of sargramostim to recovery of ANC to ≥1500/mm^3)

Full Information

NCT ID

NCT02520102

First Posted

August 7, 2015

Last Updated

April 19, 2017

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT02520102

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Withdrawn

Why Stopped

Company has fulfilled post-marketing requirements

Study Start Date

February 2017 (Anticipated)

Primary Completion Date

February 28, 2017 (Actual)

Study Completion Date

February 28, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanofi

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Myeloid Leukemia NOS

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

sargramostim

Arm Type

Experimental

Arm 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.

Intervention Type

Drug

Intervention Name(s)

sargramostim GZ402664

Other Intervention Name(s)

Leukine

Intervention Description

Pharmaceutical form: lyophilized powder in vial Route of administration: subcutaneous

Primary Outcome Measure Information:

Title

Proportion of patients who develop antibodies (binding antibodies and neutralizing antibodies)

Time Frame

1 month after 1st dose of sargramostim

Title

Proportion of patients who develop antibodies (binding antibodies and neutralizing antibodies)

Time Frame

2 months after 1st dose of sargramostim

Title

Proportion of patients who develop antibodies (binding antibodies and neutralizing antibodies)

Time Frame

3 months after 1st dose of sargramostim

Title

Proportion of patients who develop antibodies (binding antibodies and neutralizing antibodies)

Time Frame

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 Measure Information:

Title

Assessment of antibodies (antibody detection and antibody titers)

Time Frame

1 month after 1st dose of sargramostim

Title

Assessment of antibodies (antibody detection and antibody titers)

Time Frame

2 months after 1st dose of sargramostim

Title

Assessment of antibodies (antibody detection and antibody titers)

Time Frame

3 months after 1st dose of sargramostim

Title

Assessment of antibodies (antibody detection and antibody titers)

Time Frame

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

Title

Assessment of immunoglobulin levels

Time Frame

1 month after 1st dose of sargramostim

Title

Assessment of immunoglobulin levels

Time Frame

2 months after 1st dose of sargramostim

Title

Assessment of immunoglobulin levels

Time Frame

3 months after 1st dose of sargramostim

Title

Assessment of immunoglobulin levels

Time Frame

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

Title

Proportion of patients with adverse events

Time Frame

Up to 24 months

Title

Duration of neutropenia (time from initiation of sargramostim to recovery of ANC to ≥1500/mm^3)

Time Frame

Up to 42 days after first day of sargramostim administration

10. Eligibility

Sex

All

Minimum Age & Unit of Time

55 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Sciences & Operations

Organizational Affiliation

Sanofi

Official's Role

Study Director

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs