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NCT04859946 · ClinicalTrials.gov registry record · Phase 2
Itacitinib for the Prevention of Graft Versus Host Disease
A Phase 2 study of Hematologic and Lymphocytic Disorder, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Phase 2
- Development phase
- 31
- Enrollment target
- 1
- Study location
NCT04859946: Active Phase 2 study of Hematologic and Lymphocytic Disorder, sponsored by M.D. Anderson Cancer Center.
NCT04859946 is a Phase 2 study of Hematologic and Lymphocytic Disorder that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 31 participants, below the 181-participant average among 4 other Hematologic and Lymphocytic Disorder trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04859946, a Phase 2 study of Hematologic and Lymphocytic Disorder, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 31 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial studies if itacitinib plus standard of care treatment may help prevent graft-versus-host-disease (GVHD) in patients who have received an allogeneic (donor) stem cell transplant. An allogeneic transplant uses blood-making cells from a family member or unrelated donor to remove and replace a patient's abnormal blood cells. Sometimes the transplanted cells from a donor can attack the body's normal cells (called graft-versus-host disease). Giving itacitinib with standard of care treatment after the transplant may stop this from happening.
Primary Outcome
The 100-day acute grade 2-4 GvHD rate will be compared between groups using Fisher's exact test. Matched logistic regression techniques will also be considered for this endpoint. The proportion of patients with acute grade 2-4 GVHD at 100 days will be reported, along with the corresponding 95% confidence interval.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- DRUG Busulfan
- DRUG Itacitinib
- PROCEDURE Allogeneic Hematopoietic Stem Cell Transplantation
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2022-01-11 |
| Est. Completion | 2027-04-01 |
| Phase | Phase 2 |
What the registry record for NCT04859946 still lists
NCT04859946 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 181-participant average among 4 other Hematologic and Lymphocytic Disorder trials with a reported enrollment target (83% lower).
The record links to 1 condition, with Hematologic and Lymphocytic Disorder appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT04859946 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT04859946 about?
NCT04859946 is a clinical study titled "Itacitinib for the Prevention of Graft Versus Host Disease". This phase II trial studies if itacitinib plus standard of care treatment may help prevent graft-versus-host-disease (GVHD) in patients who have received an allogeneic (donor) stem cell transplant. An allogeneic transplant uses blood-making cells from a family member or unrelated donor to remove and...
What is the current status of trial NCT04859946?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 31 participants. The study started on 2022-01-11. Estimated completion is 2027-04-01.
What conditions does trial NCT04859946 study?
This clinical trial studies the following conditions: Hematologic and Lymphocytic Disorder.
What interventions are being tested in trial NCT04859946?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Busulfan (DRUG), Itacitinib (DRUG), Allogeneic Hematopoietic Stem Cell Transplantation (PROCEDURE).
Who is sponsoring clinical trial NCT04859946?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04859946 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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