Ignite Creation Date:
2024-05-06 @ 7:23 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT05996627
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2023-08-10
Brief Title:
Belumosudil for the Pre-emptive Treatment of Patients With Chronic Graft Versus Host Disease
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
Randomized Phase II Study of Belumosudil vs Placebo for Preemptive Treatment of Chronic Graft Versus Host Disease
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase II trial compares the effect of belumosudil to a placebo in treating patients with chronic graft versus host disease Chronic graft versus host disease remains a major complication of stem cell transplantation and can involve multiple organ systems Belumosudil is a ROCK2 selective inhibitor that works to reduce the immune system response causing the chronic graft versus host disease Giving belumosudil may better treat patients with chronic graft versus host disease and prevent the need for starting additional immune suppressive medications
Detailed Description:
OUTLINE Patients are randomized to 1 of 2 arms
ARM I Patients receive belumosudil orally PO daily QD or twice daily BID if taken with strong CYP3A inducers or proton pump inhibitors for days 1 through 28 of each cycle Cycles repeat every 28 days for a total of 11 cycles followed by one cycle of tapering prior to discontinuation in the absence of disease progression or unacceptable toxicity
ARM II Patients receive a placebo PO QD or BID if taken with strong CYP3A inducers or proton pump inhibitors for days 1 through 28 of each cycle Cycles repeat every 28 days for a total of 11 cycles followed by one cycle of tapering prior to discontinuation in the absence of disease progression or unacceptable toxicity
Patients undergo blood sample collection on study
Patients follow up after completion of study medication at 30 days and at 60 days if 12 cycles are completed
ARM I Patients receive belumosudil orally PO daily QD or twice daily BID if taken with strong CYP3A inducers or proton pump inhibitors for days 1 through 28 of each cycle Cycles repeat every 28 days for a total of 11 cycles followed by one cycle of tapering prior to discontinuation in the absence of disease progression or unacceptable toxicity
ARM II Patients receive a placebo PO QD or BID if taken with strong CYP3A inducers or proton pump inhibitors for days 1 through 28 of each cycle Cycles repeat every 28 days for a total of 11 cycles followed by one cycle of tapering prior to discontinuation in the absence of disease progression or unacceptable toxicity
Patients undergo blood sample collection on study
Patients follow up after completion of study medication at 30 days and at 60 days if 12 cycles are completed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2023-05293 | REGISTRY | None | None |
| RG1123523 | OTHER | None | None |
| 20163 | OTHER | Fred HutchUniversity of Washington Cancer Consortium | None |