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NCT04237623 · ClinicalTrials.gov registry record · Phase 2
GM-CSF With Post-Transplant Cyclophosphamide
A Phase 2 study of Transplant-Related Hematologic Malignancy, sponsored by Northside Hospital.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 38
- Enrollment target
- 1
- Study location
NCT04237623: Recruiting Phase 2 study of Transplant-Related Hematologic Malignancy, sponsored by Northside Hospital.
NCT04237623 is a Phase 2 study of Transplant-Related Hematologic Malignancy that is actively recruiting participants, run by Northside Hospital. The registered enrollment target is 38 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04237623, a Phase 2 study of Transplant-Related Hematologic Malignancy, is actively recruiting participants, sponsored by Northside Hospital.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 38 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- OTHER Control Arm
- DRUG Sargramostim
Study Locations (1)
Georgia
- Northside Hospital - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2020-05-18 |
| Est. Completion | 2026-09-18 |
| Phase | Phase 2 |
What NCT04237623 shows while recruiting
NCT04237623 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% lower).
The record links to 1 condition, with Transplant-Related Hematologic Malignancy appearing as the primary indexed condition, and to 2 interventions - of which Control Arm is the first listed.
NCT04237623 reports a single indexed study location in Georgia.
Frequently Asked Questions
What is clinical trial NCT04237623 about?
NCT04237623 is a clinical study titled "GM-CSF With Post-Transplant Cyclophosphamide". 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...
What is the current status of trial NCT04237623?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 38 participants. The study started on 2020-05-18. Estimated completion is 2026-09-18.
What conditions does trial NCT04237623 study?
This clinical trial studies the following conditions: Transplant-Related Hematologic Malignancy.
What interventions are being tested in trial NCT04237623?
The interventions under investigation include: Control Arm (OTHER), Sargramostim (DRUG).
Who is sponsoring clinical trial NCT04237623?
This trial is sponsored by Northside Hospital, which has 26 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04237623 being conducted?
This trial has 1 study location across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04237623's enrollment target sits among peer trials
38 1467th of 2000 higher than 518 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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