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NCT06271616 · ClinicalTrials.gov registry record · Phase 2
Ibrutinib for the Prevention of Chronic Graft-Versus-Host Disease in Patients Undergoing Donor Stem Cell Transplant
A Phase 2 study of Hematopoietic and Lymphatic System Neoplasm and Chronic Graft Versus Host Disease, sponsored by Mayo Clinic.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT06271616: Recruiting Phase 2 study of Hematopoietic and Lymphatic System Neoplasm and Chronic Graft Versus Host Disease, sponsored by Mayo Clinic.
NCT06271616 is a Phase 2 study of Hematopoietic and Lymphatic System Neoplasm and Chronic Graft Versus Host Disease that is actively recruiting participants, run by Mayo Clinic. The registered enrollment target is 40 participants, below the 483-participant average among 62 other Hematopoietic and Lymphatic System Neoplasm trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06271616, a Phase 2 study of Hematopoietic and Lymphatic System Neoplasm and Chronic Graft Versus Host Disease, is actively recruiting participants, sponsored by Mayo Clinic.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial tests how well ibrutinib works in preventing chronic graft-versus-host disease (GVHD) in patients undergoing donor (allogeneic) hematopoietic cell transplantation (HCT). An allogeneic hematopoietic cell transplantation (allo-HCT) is a treatment in which a person receives blood-forming stem cells (cells from which all blood cells develop) from a genetically similar, but not identical donor. When healthy stem cells from a donor are infused into a patient, they may help the patient's bone marrow make more healthy cells and platelets. However, sometimes the transplanted cells from a donor can attack the body's normal cells (called GVHD). Giving ibrutinib after the transplant may stop that from happening. Ibrutinib is in a class of medications called kinase inhibitors. It works by blocking a protein in the blood called Bruton's tyrosine kinase (BTK). By blocking BTK, ibrutinib inhibits certain immune cells that play a role in cGVHD. Giving ibrutinib after an allo-HCT may prevent the development of chronic GVHD.
Primary Outcome
The cumulative incidence of National Institutes of Health (NIH) moderate/severe chronic GVHD will be estimated from the date of registration using a competing risk model, with death and relapse without NIH moderate/severe chronic GVHD as the competing risks.
Conditions Studied
Interventions
- PROCEDURE Echocardiography Test
- DRUG Ibrutinib
Study Locations (1)
Florida
- Mayo Clinic in Florida - Jacksonville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2024-12-13 |
| Est. Completion | 2027-06-30 |
| Phase | Phase 2 |
What NCT06271616 shows while recruiting
NCT06271616 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 483-participant average among 62 other Hematopoietic and Lymphatic System Neoplasm trials with a reported enrollment target (92% lower).
The record links to 2 conditions, with Hematopoietic and Lymphatic System Neoplasm appearing as the primary indexed condition, and to 2 interventions - of which Echocardiography Test is the first listed.
NCT06271616 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT06271616 about?
NCT06271616 is a clinical study titled "Ibrutinib for the Prevention of Chronic Graft-Versus-Host Disease in Patients Undergoing Donor Stem Cell Transplant". This phase II trial tests how well ibrutinib works in preventing chronic graft-versus-host disease (GVHD) in patients undergoing donor (allogeneic) hematopoietic cell transplantation (HCT). An allogeneic hematopoietic cell transplantation (allo-HCT) is a treatment in which a person receives blood-fo...
What is the current status of trial NCT06271616?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2024-12-13. Estimated completion is 2027-06-30.
What conditions does trial NCT06271616 study?
This clinical trial studies the following conditions: Hematopoietic and Lymphatic System Neoplasm, Chronic Graft Versus Host Disease.
What interventions are being tested in trial NCT06271616?
The interventions under investigation include: Echocardiography Test (PROCEDURE), Ibrutinib (DRUG).
Who is sponsoring clinical trial NCT06271616?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06271616 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06271616's enrollment target sits among peer trials
40 46th of 62 higher than 14 of 62 other Hematopoietic and Lymphatic System Neoplasm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hematopoietic and Lymphatic 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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