Acute Myeloid Leukemia NOS Clinical Trial
Official title:
A Phase II Open Label Study of Sargramostim Among Patients Receiving Myelosuppressive Induction Chemotherapy for Acute Myelogenous Leukemia
| Verified date | March 2017 |
| Source | Sanofi |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | February 28, 2017 |
| Est. primary completion date | February 28, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 55 Years to 70 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Sanofi |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Proportion of patients who develop antibodies (binding antibodies and neutralizing antibodies) | 1 month after 1st dose of sargramostim | ||
| Primary | Proportion of patients who develop antibodies (binding antibodies and neutralizing antibodies) | 2 months after 1st dose of sargramostim | ||
| Primary | Proportion of patients who develop antibodies (binding antibodies and neutralizing antibodies) | 3 months after 1st dose of sargramostim | ||
| Primary | 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 | Assessment of antibodies (antibody detection and antibody titers) | 1 month after 1st dose of sargramostim | ||
| Secondary | Assessment of antibodies (antibody detection and antibody titers) | 2 months after 1st dose of sargramostim | ||
| Secondary | Assessment of antibodies (antibody detection and antibody titers) | 3 months after 1st dose of sargramostim | ||
| Secondary | 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 | ||
| Secondary | Assessment of immunoglobulin levels | 1 month after 1st dose of sargramostim | ||
| Secondary | Assessment of immunoglobulin levels | 2 months after 1st dose of sargramostim | ||
| Secondary | Assessment of immunoglobulin levels | 3 months after 1st dose of sargramostim | ||
| Secondary | 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 | ||
| Secondary | Proportion of patients with adverse events | Up to 24 months | ||
| Secondary | 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 |