Using GM-CSF after transplant to improve recovery from blood cancers
Official title: Phase II Trial Evaluating the Efficacy and Safety of Sargramostim Post-Infusion of T-Replete HLA Mismatched Peripheral Blood Haploidentical Hematopoietic Stem Cells and With Post Transplant Cyclophosphamide
Run by Northside Hospital, Inc. · NCT04237623 · Data updated 2026-11-12
This study is testing if a drug called GM-CSF can help people recovering from blood cancers after a specific type of stem cell transplant to improve their blood cell counts and reduce infection risks.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 78 Years |
| Sex | All |
| Enrollment | 38 (estimated) |
| Sponsor | Northside Hospital, Inc. Academic / other |
| Drugs / interventions | cyclophosphamide |
| Locations | 1 site (Atlanta, Georgia) |
| Status | Recruiting |
| Started | May 18, 2020 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2027 |
| Registry record updated | October 14, 2026 |
| Trial ID | NCT04237623 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients with hematologic malignancies who have a 5/10 to 8/10 matched related donor and a performance status of 70% or higher.
✕Probably not a fit
Patients with poor organ function, HIV-positive status, or severe allergic reactions to GM-CSF may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the use of GM-CSF (sargramostim) following haploidentical stem cell transplantation and post-transplant cyclophosphamide to enhance recovery rates of blood cell counts. The study aims to determine if GM-CSF can provide similar benefits to G-CSF while potentially reducing the risk of infectious complications associated with these transplants. Eligible participants include patients with various hematologic malignancies who have a matched related donor. The trial is designed to assess the safety and efficacy of this approach in improving patient outcomes.
Why it matters
Potential benefit: If successful, this treatment could lead to faster recovery of blood cell counts and lower infection risks for patients undergoing haploidentical stem cell transplants.
How similar studies have gone: Other studies have shown promising results with GM-CSF in similar contexts, suggesting potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where it's running
-
Northside Hospital
Atlanta, Georgia, United States Recruiting
Study contacts
- Principal investigator: Melhem Solh, MD — Northside Hospital
- Study coordinator: Stacey Brown, BA
- Email: stacey.brown@northside.com
- Phone: 404-780-7965
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.