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

NCT05622318 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2026-03-12

No results posted yet for this study

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.

Conditions

  • Graft-versus-host Disease

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.

Sponsors & Collaborators

  • Medical College of Wisconsin

    lead OTHER

Principal Investigators

  • Sameem Abedin, MD · Medical College of Wisconsin

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-29
Primary Completion
2026-07-31
Completion
2026-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05622318 on ClinicalTrials.gov