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ACTIVE NOT RECRUITING
NCT05622318
PHASE2

De-escalated Cyclophosphamide (PTCy) and Ruxolitinib for Graft-versus-Host Disease (GVHD) Prophylaxis

Sponsor: Medical College of Wisconsin

View on ClinicalTrials.gov

Summary

This is an open-label phase 2 study designed to explore the efficacy and safety of low-dose PTCy-ruxolitinib GVHD prophylaxis in older adults undergoing allogeneic HCT with a matched sibling or unrelated donor with a peripheral blood stem cell graft.

Official title: A Phase II Trial of De-escalated PTCy and Ruxolitinib for GVHD Prophylaxis in Patients Undergoing Reduced Intensity Conditioning Allogeneic HCT

Key Details

Gender

All

Age Range

60 Years - Any

Study Type

INTERVENTIONAL

Enrollment

56

Start Date

2023-08-29

Completion Date

2026-09

Last Updated

2026-03-12

Healthy Volunteers

No

Interventions

DRUG

Cyclophosphamide

25 mg/kg by IV on Days +3 and +4.

DRUG

Tacrolimus

Target level 5-10 ng/mL (If the subject experiences nausea and vomiting that prevents the oral intake of tacrolimus anytime during treatment, tacrolimus is to be given by IV at the appropriate dose that was used to obtain the therapeutic level \[IV:PO ratio = 1:4\]). Administered Days +5 through +90. Taper after Day +90 and discontinue on Day +180.

DRUG

Mycophenolate Mofetil

15 mg/kg tablet thrice daily Days +5 through +35 every eight hours.

DRUG

Ruxolitinib

5 mg tablet twice daily after engraftment through Day +365. Taper after Day +365.

Locations (1)

Froedtert Hospital & the Medical College of Wisconsin

Milwaukee, Wisconsin, United States