Study of Ruxolitinib for Acute and Chronic Graft Versus Host Disease

Part of paid clinical trials in Cincinnati, Ohio.

Sponsor
Children's Hospital Medical Center, Cincinnati
Study ID
NCT05121142
Phase
PHASE1
Status
Completed

Conditions

  • Acute-graft-versus-host Disease
  • Chronic Graft-versus-host-disease
  • Solid Organ Transplant

Eligibility Criteria

Sex
ALL
Age
N/A - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Ruxolitinib — DRUG
    Ruxolitinib will be given by mouth or enteral tube (if applicable).

Study Details

While hematopoietic stem cell transplant (HSCT) is an effective therapy, graft versus host disease (GVHD) is the most significant complication after HSCT. Both acute GVHD and chronic GVHD are leading causes of non-relapse morbidity and mortality. Patients with solid organ transplants may participate in this study as well because these patients occasionally develop acute GVHD, which is biologically similar to acute GVHD after an HSCT. Acute graft versus host disease usually occurs within the first 100 days of transplant and can involve the skin, gut, or liver. Chronic graft versus host disease usually occurs after the first 100 days of transplant and can involve skin, eyes, mouth, joints, liver, intestines commonly. These two diseases are different, but both happen due to the imbalance of the donor immune system in the host. The purpose of this research is to learn more about ruxolitinib as a treatment for both acute and chronic GVHD. Specifically, the investigators would like to learn more about the pharmacokinetics (PK - the process of absorption, distribution, metabolism, and elimination from the body - meaning how the drug moves through the body) and the pharmacodynamics (PD - the body's biological response to the drug) of ruxolitinib.

Key Dates

Start date
Oct 27, 2021
Status verified
Jan 2024
Primary completion
May 13, 2023
Completion
May 13, 2023

Study Design

Enrollment
13 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: Arm 1: Existing patients with chronic GVHD
    Participants with established diagnosis of chronic GVHD and currently on treatment with ruxolitinib for chronic GVHD for at least 3 weeks. Participants in this arm are receiving ruxolitinib clinically and will not receive ruxolitinib as part of this research study.
  • Experimental: Arm 2: Acute GVHD ages 0-<12 years
    Participants with acute GVHD will receive ruxolitinib on this arm.
  • Experimental: Arm 3: New onset chronic GVHD ages 0-≤18 years
    Participants with new onset chronic GVHD will receive ruxolitinib on this arm.

Primary Outcome Measure

Cmax of ruxolitinib in existing patients with chronic GVHD (Arm 1) [ Time Frame: 1 week ]

Locations (1)

FacilityCityStateZIPSite coordinators
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229-

Find similar trials in Cincinnati, OH

By research site
Cincinnati Children's Hospital Medical Center· Cincinnati, OH

Related Studies