Clinical trial · Interventional
Open Label Study of Sargramostim Among Patients Receiving Myelosuppressive Induction Chemotherapy for Acute Myelogenous Leukemia
A Phase II Open Label Study of Sargramostim Among Patients Receiving Myelosuppressive Induction Chemotherapy for Acute Myelogenous Leukemia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Company has fulfilled post-marketing requirements
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia NOS | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| sargramostim GZ402664 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- sargramostim
- 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.
- interventionNames
- Drug: sargramostim GZ402664
Primary outcomes (4)
- measure
- Proportion of patients who develop antibodies (binding antibodies and neutralizing antibodies)
- timeFrame
- 1 month after 1st dose of sargramostim
- measure
- Proportion of patients who develop antibodies (binding antibodies and neutralizing antibodies)
- timeFrame
- 2 months after 1st dose of sargramostim
- measure
- Proportion of patients who develop antibodies (binding antibodies and neutralizing antibodies)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 55 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available