Acute Myeloid Leukemia NOS MedDRA version: 18.0 Level: PT Classification code 10000880 Term: Acute myeloid leukaemia System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Leukine
Product Code: GZ402664
Pharmaceutical Form: Lyophilisate for solution for injection
INN or Proposed INN: SARGRAMOSTIM
CAS Number: 123774-72-1
Current Sponsor code: GZ402664
Concent
Sponsors
Genzyme Corporation
Eligibility
Sex/Gender
All
Inclusion 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 =65 years) yes F.1.3.1 Number of subjects for this age range 75
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Measure the proportion of patients who develop binding and neutralizing antibodies in the blood after treatment with sargramostim following induction/reinduction chemotherapy.;Secondary Objective: 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.;Primary end point(s): a) Proportion of patients who develop antibodies (binding antibodies and neutralizing antibodies) b) Proportion of patients who develop antibodies (binding antibodies and neutralizing antibodies) c) Proportion of patients who develop antibodies (binding antibodies and neutralizing antibodies) d) Proportion of patients who develop antibodies (binding antibodies and neutralizing antibodies);Timepoint(s) of evaluation of this end point: a) 1 month after 1st dose of sargramostim b) 2 months after 1st dose of sargramostim c) 3 months after 1st dose of sargramostim d) 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): a) Assessment of antibodies (antibody detection and antibody titers) b) Assessment of antibodies (antibody detection and antibody titers) c) Assessment of antibodies (antibody detection and antibody titers) d) Assessment of antibodies (antibody detection and antibody titers) e) Assessment of immunoglobulin levels f) Assessment of immunoglobulin levels g) Assessment of immunoglobulin levels h) Assessment of immunoglobulin levels i) Proportion of patients with adverse events l) Duration of neutropenia (time from initiation of sargramostim to recovery of ANC to =1500/mm^3);Timepoint(s) of evaluation of this end point: a) 1 month after 1st dose of sargramostim b) 2 months after 1st dose of sargramostim c) 3 months after 1st dose of sargramostim d) 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 e) 1 month after 1st dose of sargramostim f) 2 months after 1st dose of sargramostim g) 3 months after 1st dose of sargramostim h) 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 i) Up to 24 months l) Up to 42 days after first day of sargramostim administration | — |
Countries
Brazil, Bulgaria, Croatia, Czech Republic, Hungary, Italy, Romania, Russian Federation, Serbia
Contacts
Public ContactMedical Information Genzyme Europe
Genzyme Europe B.V.
Outcome results
None listed