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GM-CSF with Post-Transplant Cyclophosphamide for Hematologic Malignancies

This study is looking at whether a drug called Sargramostim (also known as GM-CSF) can help people with blood cancers (hematologic malignancies) recover faster after a stem cell transplant. Specifically, it's being given after a type of transplant that uses cells from a partially matched donor and a drug called cyclophosphamide. Researchers want to see if Sargramostim helps your body make new white blood cells (neutrophil engraftment) within 20 days, which is measured 3 months after treatment starts. You might be able to join if you are 18 to 78 years old, have certain blood cancers, and have a partially matched related donor. The study is currently unclear about its recruitment status.

Study design
This is an interventional study with a planned enrollment of 38 participants. It compares Sargramostim to standard G-CSF for those who decline Sargramostim.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome of neutrophil engraftment is measured at 3 months after initial treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04237623

GM-CSF With Post-Transplant Cyclophosphamide

Recruiting
PHASE2Ages 18–78InterventionalSupportive care
Northside Hospital, Inc.
~38 participants
Updated 2026-04-16 on ClinicalTrials.gov
What's tested:SargramostimControl Arm

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The number of patients who achieved neutrophil engraftment at 20 days after the initiation of treatment.
Measured over 3 months after initial treatment

Conditions

Transplant-Related Hematologic Malignancy

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Acute Lymphoblastic LeukemiaAcute Myeloid LeukemiaChronic Lymphocytic LeukemiaChronic Myeloid Leukemia, BCR-ABL1 PositiveChronic Myelomonocytic LeukemiaHematologic NeoplasmHodgkin's GranulomaMultiple MyelomaMyelodysplastic SyndromeMyeloproliferative disorderNon-Hodgkin Lymphoma

Where it's being run

1 sites across 1 states
Georgia1

Study leadership

  • Melhem Solh, MD · PRINCIPAL_INVESTIGATOR · Northside Hospital

Who to contact

Stacey Brown, BA
[email protected]
404-780-7965
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Availability of 5/10 to 8/10 matched related donor
KPS \>/= 70%
CML, AML, MDS, ALL, CLL, HD, NHL, MPS/CMML, MM, any other hematologic condition deemed an eligible indication for allogeneic transplant by the treating center

Exclusion

Poor cardiac, pulmonary, liver, and renal function
HIV-positive
Patients who have a debilitating medical or psychiatric illness that would preclude them from giving informed consent
History of severe or serious allergic reaction to human GM-CSF or yeast-derived products

What this trial measures

  • The number of patients who achieved neutrophil engraftment at 20 days after the initiation of treatment.3 months after initial treatment

    The aim of the study is to establish equivalent effectiveness of Sargramostim to a matched control cohort of G-CSF treated patients in time to achieve neutrophil (ANC \>500 x3 days) post infusion of HLA-mismatched peripheral blood haploidentical stem cells with post-transplant cyclophosphamide. Patients will be followed for 3 months following the initiation of treatment to see engraftment numbers at 20 days after initial treatment.