A Phase 2 interventional study of Acalabrutinib and Questionnaire Administration in Recurrent Moderate-Severe Chronic Graft Versus Host Disease and Hematopoietic and Lymphoid Cell Neoplasm, sponsored by Fred Hutchinson Cancer Center. Active, not recruiting at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-05.
Sponsored by Fred Hutchinson Cancer Center · Phase 2, Interventional, and Treatment
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.
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.
1,464 studies on the registry are indexed under Hematologic Neoplasms; 433 are open to participants now.
This study's enrollment of 51 is above the median of 45 across 1,068 interventional studies indexed under Hematologic Neoplasms.
Browse Hematologic Neoplasms studies →Fred Hutchinson Cancer Center is the lead sponsor of 537 studies on the registry; 79 are open to participants now.
Of its 57 completed or terminated interventional studies of FDA-regulated products, 45 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients receive acalabrutinib 100 mg PO 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.
Drug: Acalabrutinib · Other: Questionnaire Administration
Given PO
Also known as: 1420477-60-6, ACP-196, Benzamide, Bruton Tyrosine Kinase Inhibitor ACP-196
Ancillary studies
Best response (complete and partial response [CR + PR])
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.
Time frame: Within the first 6 months of treatment when the best response rate is known for each patient
Incidence of adverse events (AEs)
Defined as grade 3 and above according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 and all serious AEs (SAEs) described for the population receiving at least one dose of acalabrutinib at least from the time of consent through the safety follow-up period. Any AE/SAE at least possibly related to acalabrutinib therapy will be reported for the duration of the study.
Time frame: Up to 30 days following the last dose of acalabrutinib
Duration of response (DOR)
Will be described for the group achieving at least a PR, defined as the number of weeks the subject maintains a PR or CR. Will be estimated using the Kaplan-Meier method. Approximate 95% CIs for median DOR will be computed using the formula proposed by Brookmeyer and Crowley.
Time frame: From the date the PR is documented until loss of the response or start of another systemic immunosuppressive treatment for chronic graft versus host disease (GVHD), whichever occurs first, assessed up to 3 years
Change in patient-reported outcomes: Lee Chronic GVHD Symptom Scale score
Will be assessed by the Lee Chronic GVHD Symptom Scale score. Scores will be calculated based on published algorithms with absolute changes and clinically meaningful changes described for the population as a whole and based on CR + PR versus stable disease (SD) + mixed response (MR) + progressive disease (PD).
Time frame: Baseline up to 3 years
Change in patient-reported outcomes: Patient-Reported Outcomes Measurement Information System-29
Will be assessed by the Patient-Reported Outcomes Measurement Information System-29. Scores will be calculated based on published algorithms with absolute changes and clinically meaningful changes described for the population as a whole and based on CR + PR versus stable disease (SD) + mixed response (MR) + progressive disease (PD).
Time frame: Baseline up to 3 years
Failure-free survival
Will be defined as the duration of relapse-free survival without adding any other systemic treatment for chronic GVHD. Will be estimated with the composite event of death from any cause, relapse and addition of secondary immune suppressive agents using the Kaplan-Meier method. Systemic immune-suppressive agents include orally or intravenously administered systemically active immune-suppressive drugs, as well as procedures including extra-corporeal photopheresis.
Time frame: At 6 months and 1 year
Organ-specific response rates
Response rates by organ will also be calculated and reported as ORR (CR+PR) versus all other categories (SD, PD, MR).
Time frame: Up to 3 years
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is active, not recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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Fred Hutchinson Cancer Center