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

Information source: Sanofi
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acute Myeloid Leukemia NOS

Intervention: sargramostim GZ402664 (Drug)

Phase: Phase 2

Status: Not yet recruiting

Sponsored by: Sanofi

Official(s) and/or principal investigator(s):
Clinical Sciences & Operations, Study Director, Affiliation: Sanofi

Overall contact:
Trial Transparency Team, Email: Contact-US@sanofi.com

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.

Clinical Details

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

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

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

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

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

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

Secondary outcome:

Assessment of antibodies (antibody detection and antibody titers)

Assessment of antibodies (antibody detection and antibody titers)

Assessment of antibodies (antibody detection and antibody titers)

Assessment of antibodies (antibody detection and antibody titers)

Assessment of immunoglobulin levels

Assessment of immunoglobulin levels

Assessment of immunoglobulin levels

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)

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.

Eligibility

Minimum age: 55 Years. Maximum age: 70 Years. Gender(s): Both.

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.

Locations and Contacts

Trial Transparency Team, Email: Contact-US@sanofi.com

Additional Information

Starting date: August 2015
Last updated: August 7, 2015

Page last updated: August 23, 2015

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