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NCT04339101 · ClinicalTrials.gov registry record · Phase 2
Itacitinib, Tacrolimus, and Sirolimus for the Prevention of GVHD in Patients With Acute Leukemia, Myelodysplastic Syndrome, or Myelofibrosis Undergoing Reduced Intensity Conditioning Donor Stem Cell Transplantation
A Phase 2 study of Myelodysplastic Syndrome and Acute Leukemia, sponsored by City of Hope Medical Center.
- Active
- Registry status
- Phase 2
- Development phase
- 59
- Enrollment target
- 1
- Study location
NCT04339101 is a Phase 2 study of Myelodysplastic Syndrome and Acute Leukemia that is active but no longer recruiting, run by City of Hope Medical Center. The registered enrollment target is 59 participants, below the 207-participant average among 134 other Myelodysplastic Syndrome trials with a reported enrollment target (71% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04339101, a Phase 2 study of Myelodysplastic Syndrome and Acute Leukemia, is active but no longer recruiting, sponsored by City of Hope Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 59 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase IIa trial studies the side effects of itacitinib when given together with standard treatment (tacrolimus and sirolimus), and to see how well it works in preventing graft-versus-host-disease (GVHD) in patients with acute leukemia, myelodysplastic syndrome or myelofibrosis who are undergoing reduced intensity conditioning donor stem cell transplantation. GVHD is a common complication after donor stem cell transplantation, resulting from donor immune cells recognizing recipients' cells and attacking them. Adding itacitinib to tacrolimus and sirolimus may reduce the risk GVHD and ultimately improve overall outcome and survival after donor stem cell transplantation.
Conditions Studied
Interventions
- DRUG Fludarabine
- DRUG Melphalan
- OTHER Quality-of-Life Assessment
- OTHER Questionnaire Administration
- DRUG Itacitinib Adipate
Study Locations (1)
California
- City of Hope Medical Center - Duarte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2020-11-11 |
| Est. Completion | 2026-01-20 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04339101
The ClinicalTrials.gov registry entry for NCT04339101 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 59 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 207-participant average among 134 other Myelodysplastic Syndrome trials with a reported enrollment target (71% lower). The listed sponsor is City of Hope Medical Center, which has 582 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Myelodysplastic Syndrome appearing as the primary indexed condition, and to 5 interventions - of which Fludarabine is the first listed.
NCT04339101 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT04339101 about?
NCT04339101 is a clinical study titled "Itacitinib, Tacrolimus, and Sirolimus for the Prevention of GVHD in Patients With Acute Leukemia, Myelodysplastic Syndrome, or Myelofibrosis Undergoing Reduced Intensity Conditioning Donor Stem Cell Transplantation". This phase IIa trial studies the side effects of itacitinib when given together with standard treatment (tacrolimus and sirolimus), and to see how well it works in preventing graft-versus-host-disease (GVHD) in patients with acute leukemia, myelodysplastic syndrome or myelofibrosis who are undergoin...
What is the current status of trial NCT04339101?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 59 participants. The study started on 2020-11-11. Estimated completion is 2026-01-20.
What conditions does trial NCT04339101 study?
This clinical trial studies the following conditions: Myelodysplastic Syndrome, Acute Leukemia, Primary Myelofibrosis, Secondary Myelofibrosis, Hematologic and Lymphocytic Disorder.
What interventions are being tested in trial NCT04339101?
The interventions under investigation include: Fludarabine (DRUG), Melphalan (DRUG), Quality-of-Life Assessment (OTHER), Questionnaire Administration (OTHER), Itacitinib Adipate (DRUG).
Who is sponsoring clinical trial NCT04339101?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04339101 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.