EligibleTrials

Sargramostim: clinical trials recruiting now

4
Recruiting trials
15
Conditions studied
4
US states with sites
1
Countries

FDA drug label

FDA-approved
Yes. Sargramostim appears in the FDA drug-label database. Marketed as Leukine.
Drug class
Leukocyte Growth Factor (FDA established pharmacologic class)

FDA-approved use

LEUKINE is a leukocyte growth factor indicated: To shorten time to neutrophil recovery and to reduce the incidence of severe and life-threatening infections and infections resulting in death following induction chemotherapy in adult patients 55 years and older with acute myeloid leukemia (AML). ( 1.1 ) For the mobilization of hematopoietic progenitor cells into peripheral blood for collection by leukapheresis and autologous transplantation in adult patients. ( 1.2 ) For the acceleration of myeloid reconstitution following autologous bone marrow or peripheral blood progenitor cell transplantation in adult and pediatric patients 2 years of age and older. ( 1.3 ) For the acceleration of myeloid reconstitution following allogeneic bone marrow transplantation in adult and pediatric patients 2 years of age and older. ( 1.4 ) For treatment of delayed neutrophil recovery or graft failure after autologous or allogeneic bone marrow transplantation in adult and pediatric patients 2 years of age and older. ( 1.5 ) To increase survival in adult and pediatric patients from birth to 17 years of age acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation S…

FDA recalls / enforcement

Reason (FDA)ClassificationStatusInitiated
FAILED STABILITY SPECIFICATION: Out-of-specification (OOS) result observed for Leukine (sargramostim) at the 27-month stability timepoint. — Partner Therapeutics Inc Class III (FDA: unlikely to cause harm) Terminated 2021-06-23

FDA label via openFDA

Phase breakdown

Phase 1 1 Phase 2 4

Conditions being studied

ConditionTrials
Anatomic Stage IV Breast Cancer AJCC v82
Breast cancer2
Lung cancer2
Metastatic Triple-Negative Breast Carcinoma2
Stage IV Lung Cancer AJCC v82
Alzheimer Disease1
Alzheimer's disease1
Anatomic Stage III Breast Cancer AJCC v81
Anatomic Stage IIIA Breast Cancer AJCC v81
Anatomic Stage IIIB Breast Cancer AJCC v81
Anatomic Stage IIIC Breast Cancer AJCC v81
Breast Adenocarcinoma1
Clinical Stage III Cutaneous Melanoma AJCC v81
Clinical Stage III Gastric Cancer AJCC v81
Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v81

Recruiting trials involving Sargramostim

Common questions

Is Sargramostim FDA-approved?

Yes, marketed as Leukine.

How many recruiting trials involve Sargramostim?

4 recruiting trials across 15 conditions.

Is this list of trials complete?

No. For the full record, search ClinicalTrials.gov.

Get notified when new trials open

One email when new recruiting trials are added. Unsubscribe anytime.