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NCT04198922 · ClinicalTrials.gov registry record · Phase 2
Acalabrutinib for the Treatment of Chronic Graft Versus Host Disease
A Phase 2 study of Hematopoietic and Lymphoid Cell Neoplasm and Recurrent Moderate-Severe Chronic Graft Versus Host Disease, sponsored by Fred Hutchinson Cancer Center.
- Active
- Registry status
- Phase 2
- Development phase
- 51
- Enrollment target
- 6
- Study locations
NCT04198922: Active Phase 2 study of Hematopoietic and Lymphoid Cell Neoplasm and Recurrent Moderate-Severe Chronic Graft Versus Host Disease, sponsored by Fred Hutchinson Cancer Center.
NCT04198922 is a Phase 2 study of Hematopoietic and Lymphoid Cell Neoplasm and Recurrent Moderate-Severe Chronic Graft Versus Host Disease that is active but no longer recruiting, run by Fred Hutchinson Cancer Center. The registered enrollment target is 51 participants, below the 952-participant average among 104 other Hematopoietic and Lymphoid Cell Neoplasm trials with a reported enrollment target (95% lower). The trial reports 6 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04198922, a Phase 2 study of Hematopoietic and Lymphoid Cell Neoplasm and Recurrent Moderate-Severe Chronic Graft Versus Host Disease, is active but no longer recruiting, sponsored by Fred Hutchinson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 51 participants
- Enrollment target
- 6
- Study locations
Study Summary
This phase II trial studies how well acalabrutinib works in treating patients with chronic graft versus host disease. Acalabrutinib may be an effective treatment for graft-versus-host disease caused by a stem cell transplant.
Primary Outcome
The composite outcome of CR and PR, calculated according to the proposed response definitions of the 2014 National Institutes of Health Consensus Conference. Exact 95% confidence intervals (CI) will be calculated for the objective response rate using the Clopper and Pearson method. Will also compare the observed best ORR with the published efficacy of ibrutinib (67%) and provide the 95% CI for the difference.
Conditions Studied
Interventions
- OTHER Questionnaire Administration
- DRUG Acalabrutinib
Study Locations (6)
Florida
- Moffitt Cancer Center - Tampa
New York
- Roswell Park Comprehensive Cancer Center - Buffalo
Ohio
- The Ohio State University Wexner Medical Center - Columbus
Tennessee
- Vanderbilt University Medical Center - Nashville
Texas
- The University of Texas MD Anderson Cancer Center - Houston
Washington
- Fred Hutch/University of Washington Cancer Consortium - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2020-12-11 |
| Est. Completion | 2027-04-30 |
| Phase | Phase 2 |
What the registry record for NCT04198922 still lists
NCT04198922 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 952-participant average among 104 other Hematopoietic and Lymphoid Cell Neoplasm trials with a reported enrollment target (95% lower).
The record links to 2 conditions, with Hematopoietic and Lymphoid Cell Neoplasm appearing as the primary indexed condition, and to 2 interventions - of which Questionnaire Administration is the first listed.
NCT04198922 lists 6 locations in 6 states (Florida, New York, Ohio).
Frequently Asked Questions
What is clinical trial NCT04198922 about?
NCT04198922 is a clinical study titled "Acalabrutinib for the Treatment of Chronic Graft Versus Host Disease". This phase II trial studies how well acalabrutinib works in treating patients with chronic graft versus host disease. Acalabrutinib may be an effective treatment for graft-versus-host disease caused by a stem cell transplant.
What is the current status of trial NCT04198922?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 51 participants. The study started on 2020-12-11. Estimated completion is 2027-04-30.
What conditions does trial NCT04198922 study?
This clinical trial studies the following conditions: Hematopoietic and Lymphoid Cell Neoplasm, Recurrent Moderate-Severe Chronic Graft Versus Host Disease.
What interventions are being tested in trial NCT04198922?
The interventions under investigation include: Questionnaire Administration (OTHER), Acalabrutinib (DRUG).
Who is sponsoring clinical trial NCT04198922?
This trial is sponsored by Fred Hutchinson Cancer Center, which has 483 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04198922 being conducted?
This trial has 6 study locations across Florida, New York, Ohio, Tennessee, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04198922's enrollment target sits among peer trials
51 62nd of 104 higher than 43 of 104 other Hematopoietic and Lymphoid Cell Neoplasm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hematopoietic and Lymphoid Cell 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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