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

Phase 1

• Conditions: Acute Myeloid Leukemia NOS; MedDRA version: 18.0Level: PTClassification code 10000880Term: Acute myeloid leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-000479-28-CZ
• Lead Sponsor: Genzyme Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-06-23
• Last Update Posted: 4 March 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 165

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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 75

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified