Trials / Active Not Recruiting
Active Not RecruitingNCT04198922
Acalabrutinib for the Treatment of Chronic Graft Versus Host Disease
Acalabrutinib for Chronic Graft-Versus-Host Disease
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 51 (actual)
- Sponsor
- Fred Hutchinson Cancer Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
OUTLINE: Patients receive acalabrutinib orally (PO) twice daily (BID) on days 1-28. Treatment repeats every 28 days for up to 6 cycles with an option to continue for up to 24 cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days and then periodically thereafter.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Acalabrutinib | Given PO |
| OTHER | Questionnaire Administration | Ancillary studies |
Timeline
- Start date
- 2020-12-11
- Primary completion
- 2025-09-29
- Completion
- 2027-04-30
- First posted
- 2019-12-13
- Last updated
- 2025-11-05
Locations
6 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04198922. Inclusion in this directory is not an endorsement.