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NCT04572815 · ClinicalTrials.gov registry record · Phase 2
Ustekinumab for the Prevention of Acute Graft-versus-Host Disease After Unrelated Donor Hematopoietic Cell Transplant
A Phase 2 study of Hematopoietic and Lymphoid System Neoplasm and Hematologic and Lymphocytic Disorder, sponsored by Fred Hutchinson Cancer Center.
- Active
- Registry status
- Phase 2
- Development phase
- 116
- Enrollment target
- 4
- Study locations
NCT04572815: Active Phase 2 study of Hematopoietic and Lymphoid System Neoplasm and Hematologic and Lymphocytic Disorder, sponsored by Fred Hutchinson Cancer Center.
NCT04572815 is a Phase 2 study of Hematopoietic and Lymphoid System Neoplasm and Hematologic and Lymphocytic Disorder that is active but no longer recruiting, run by Fred Hutchinson Cancer Center. The registered enrollment target is 116 participants, below the 1,355-participant average among 31 other Hematopoietic and Lymphoid System Neoplasm trials with a reported enrollment target (91% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04572815, a Phase 2 study of Hematopoietic and Lymphoid System Neoplasm and Hematologic and Lymphocytic Disorder, is active but no longer recruiting, sponsored by Fred Hutchinson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 116 participants
- Enrollment target
- 4
- Study locations
Study Summary
This phase II trial studies how well ustekinumab works in preventing acute graft-versus-host disease after unrelated donor hematopoietic cell transplant. Sometimes the transplanted cells from a donor can attack the body's normal tissues (called graft-versus-host disease). Giving ustekinumab after the transplant may help prevent acute graft-versus-host disease by controlling the body's immune response. Funding Source- FDA OOPD.
Primary Outcome
Will be treated as a binary outcome, and the Cochran-Mantel-Haenszel test will be used to compare the two groups based on the stratification factors.
Conditions Studied
Interventions
- OTHER Quality-of-Life Assessment
- OTHER Questionnaire Administration
- DRUG Placebo Administration
- BIOLOGICAL Ustekinumab
Study Locations (4)
California
- City of Hope Comprehensive Cancer Center, - Duarte
Florida
- H. Lee Moffitt Cancer Center & Research Institute - Tampa
New York
- Roswell Park Cancer Institute - Buffalo
Washington
- Fred Hutch/University of Washington Cancer Consortium - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 116 participants |
| Start Date | 2021-05-14 |
| Est. Completion | 2027-06-30 |
| Phase | Phase 2 |
What the registry record for NCT04572815 still lists
NCT04572815 is an interventional study that assigns participants to a tested intervention. The registered 116 participants enrollment target is mid-sized for trials with a published cap, below the 1,355-participant average among 31 other Hematopoietic and Lymphoid System Neoplasm trials with a reported enrollment target (91% lower).
The record links to 2 conditions, with Hematopoietic and Lymphoid System Neoplasm appearing as the primary indexed condition, and to 4 interventions - of which Quality-of-Life Assessment is the first listed.
NCT04572815 reports a single indexed study location in California, Florida, New York.
Frequently Asked Questions
What is clinical trial NCT04572815 about?
NCT04572815 is a clinical study titled "Ustekinumab for the Prevention of Acute Graft-versus-Host Disease After Unrelated Donor Hematopoietic Cell Transplant". This phase II trial studies how well ustekinumab works in preventing acute graft-versus-host disease after unrelated donor hematopoietic cell transplant. Sometimes the transplanted cells from a donor can attack the body's normal tissues (called graft-versus-host disease). Giving ustekinumab after th...
What is the current status of trial NCT04572815?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 116 participants. The study started on 2021-05-14. Estimated completion is 2027-06-30.
What conditions does trial NCT04572815 study?
This clinical trial studies the following conditions: Hematopoietic and Lymphoid System Neoplasm, Hematologic and Lymphocytic Disorder.
What interventions are being tested in trial NCT04572815?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), Questionnaire Administration (OTHER), Placebo Administration (DRUG), Ustekinumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT04572815?
This trial is sponsored by Fred Hutchinson Cancer Center, which has 483 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04572815 being conducted?
This trial has 4 study locations across California, Florida, New York, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hematopoietic and Lymphoid System Neoplasm
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04572815's enrollment target sits among peer trials
116 15th of 31 higher than 17 of 31 other Hematopoietic and Lymphoid System Neoplasm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hematopoietic and Lymphoid System Neoplasm 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.
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