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

NCT02520102 | Withdrawn Phase 2 FDA Drug

• 2 other identifiers: LTS13932U1111-1148-1183
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acute Myeloid Leukemia NOS

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (10)

• 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

Study Arms (1)

sargramostim

EXPERIMENTAL

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

Interventions

sargramostim GZ402664 DRUG

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

Also known as: Leukine

sargramostim

Eligibility Criteria

• Age: 55 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

sargramostim

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2015
• First Posted: August 11, 2015
• Study Start: February 1, 2017
• Primary Completion: February 28, 2017
• Study Completion: February 28, 2017
• Last Updated: April 20, 2017

Record last verified: 2017-03