NCT04237623 GM-CSF With Post-Transplant Cyclophosphamide
| NCT ID | NCT04237623 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Northside Hospital, Inc. |
| Condition | Transplant-Related Hematologic Malignancy |
| Study Type | INTERVENTIONAL |
| Enrollment | 38 participants |
| Start Date | 2020-05-18 |
| Primary Completion | 2026-09-18 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 38 participants in total. It began in 2020-05-18 with a primary completion date of 2026-09-18.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Given the increased number of HLA-mismatched haploidentical transplantation with post-transplant cyclophosphamide performed each year and the high risk of infectious complications associated with this type of transplant, the investigators suggest that GM-CSF administration post-infusion of T-replete haploidentical stem cells and post-transplant cyclophosphamide can yield similar count recovery rates to G-CSF with a potential of lowering risk of infectious complications.
Eligibility 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
Contact & Investigator
Melhem Solh, MD
PRINCIPAL INVESTIGATOR
Northside Hospital
Frequently Asked Questions
Who can join the NCT04237623 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 78 Years, studying Transplant-Related Hematologic Malignancy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04237623 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04237623 currently recruiting?
Yes, NCT04237623 is actively recruiting participants. Contact the research team at stacey.brown@northside.com for enrollment information.
Where is the NCT04237623 trial being conducted?
This trial is being conducted at Atlanta, United States.
Who is sponsoring the NCT04237623 clinical trial?
NCT04237623 is sponsored by Northside Hospital, Inc.. The principal investigator is Melhem Solh, MD at Northside Hospital. The trial plans to enroll 38 participants.