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

Part of paid clinical trials in Milwaukee, Wisconsin.

Sponsor
Medical College of Wisconsin
Study ID
NCT05622318
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cyclophosphamide — DRUG
    25 mg/kg by IV on Days +3 and +4.
  • Tacrolimus — DRUG
    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.
  • Mycophenolate Mofetil — DRUG
    15 mg/kg tablet thrice daily Days +5 through +35 every eight hours.
  • Ruxolitinib — DRUG
    5 mg tablet twice daily after engraftment through Day +365. Taper after Day +365.

Study Details

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.

Key Dates

Start date
Aug 29, 2023
Status verified
Mar 2026
Primary completion
Jul 31, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
56 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Graft-versus-host disease prophylaxis
    Following reduced intensity conditioning and 8/8-matched peripheral blood transplant on Day 0, all patients will receive a GVHD prophylaxis post-transplant composed of the following: (i) cyclophosphamide administered at 25 mg/kg on Day +3 and +4, (ii) tacrolimus beginning on Day +5 and through Day +180 and administered with a trough target of 5-10 ng/ml through Day +90 and tapered thereafter; (iii) mycophenolate mofetil (MMF) administered at 15 mg/kg thrice daily beginning on Day +5 through Day +35; and (iv) ruxolitinib administered at 5 mg twice daily starting after engraftment (between Days +30 and +60) and continuing through one year post transplant.

Primary Outcome Measure

The number of subjects who experience GVHD-free survival. [ Time Frame: One year (365 Days) after hematopoietic cell transplantation (HCT) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Froedtert Hospital & the Medical College of WisconsinMilwaukeeWisconsin53226-

Find similar trials in Milwaukee, WI

By research site
Froedtert Hospital & the Medical College of Wisconsin· Milwaukee, WI

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