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Ruxolitinib for Graft-Versus-Host Disease Prevention

Phase 1

Waitlist Available

Led By Ramzi Abboud, M.D.

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from day -3 to day 30

Awards & highlights

Study Summary

This trial is testing a new therapy that can cure blood cancers. It works by using a donor that's a close match, and reducing the risk of side effects from the treatment.

Who is the study for?

This trial is for adults with certain blood cancers who are in remission and have a closely related family member as a donor. They must be healthy enough for stem cell harvesting, not HIV or HTLV positive, and agree to use birth control. People can't join if they've had previous allogeneic transplants, active hepatitis or HIV, severe allergies to study drugs, or are pregnant.Check my eligibility

What is being tested?

The trial tests Ruxolitinib's ability to prevent graft-versus-host disease (GVHD) and cytokine release syndrome after receiving stem cells from half-matched donors. It aims to see if the drug can protect patients without harming the anti-cancer effects of the transplant.See study design

What are the potential side effects?

Ruxolitinib may cause side effects like low blood counts leading to increased infection risk, bleeding problems, dizziness upon standing due to low blood pressure, headaches and other pains. The full extent of side effects will be monitored throughout the trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from day -3 to day 30

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from day -3 to day 30

This trial's timeline: 3 weeks for screening, Varies for treatment, and from day -3 to day 30 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Cumulative incidence of grades III-IV acute GVHD by MAGIC criteria

Cumulative incidence of graft failure (Phase I only)

Number of patients who experience CRS

Secondary outcome measures

Cumulative incidence of grades II-IV acute GVHD by MAGIC criteria

Feasibility of regimen (Phase I only)

Treatment-related mortality

Side effects data

From 2020 Phase 3 trial • 149 Patients • NCT02038036

33%

Anaemia

19%

Hypertension

17%

Nasopharyngitis

16%

Weight increased

14%

Herpes zoster

14%

Constipation

14%

Abdominal pain

14%

Headache

12%

Pruritus

12%

Back pain

12%

Epistaxis

12%

Pyrexia

12%

Dizziness

10%

Asthenia

10%

Fatigue

10%

Cough

10%

Oedema peripheral

10%

Arthralgia

Thrombocytosis

Upper respiratory tract infection

Hypercholesterolaemia

Dyslipidaemia

Pain in extremity

Haematoma

Abdominal discomfort

Diarrhoea

Dyspepsia

Vomiting

Blood lactate dehydrogenase increased

Memory impairment

Dyspnoea

Tinnitus

Osteoarthritis

Leukocytosis

Thrombocytopenia

Flatulence

Nausea

Sinusitis

Basal cell carcinoma

Neuropathy peripheral

Hyperuricaemia

Blood creatine phosphokinase increased

Cystitis

Bronchitis

Paraesthesia

Skin ulcer

Abdominal pain upper

Pulmonary embolism

Pneumonia

Influenza

Myalgia

Urinary tract infection

Depression

Localised infection

Urethral stenosis

Night sweats

Acute pulmonary oedema

Intervertebral disc protrusion

Vertigo

Peripheral artery thrombosis

Ureterolithiasis

Pericardial effusion

Acute myocardial infarction

Syncope

Gastrooesophageal reflux disease

General physical health deterioration

Atrial fibrillation

Cardiac disorder

Mitral valve incompetence

Vertigo positional

Retinal artery occlusion

Visual acuity reduced

Gastrointestinal haemorrhage

Oesophageal varices haemorrhage

Lower respiratory tract infection

Pyelonephritis

Respiratory tract infection

Sepsis

Tendon rupture

Ulna fracture

Weight decreased

Decreased appetite

Hyponatraemia

Blast cell crisis

Bone marrow tumour cell infiltration

Lung adenocarcinoma

Metastases to spine

Myelofibrosis

Prostatic adenoma

Squamous cell carcinoma of skin

Nephrolithiasis

Gamma-glutamyltransferase increased

Haematocrit increased

Musculoskeletal pain

Ischaemic stroke

Diabetes mellitus

100%

80%

60%

40%

20%

Study treatment Arm

All Crossover Patients

Best Available Therapy

Ruxolitinib

Trial Design

2Treatment groups

Experimental Treatment

Group I: Phase I: RuxolitinibExperimental Treatment1 Intervention

Ruxolitinib at 5 mg twice per day (BID) beginning on Day -3 and continuing until Day 180 followed by a taper (duration of taper depends on dose of ruxolitinib at Day 180). Once a patient's counts have reached ANC > 1.5 K/cumm, hemoglobin > 9.0 g/dL, and platelets > 50 K/cumm, ruxolitinib dosing will escalate to 10 mg BID. Ruxolitinib starting dose for patients receiving fluconazole will be 5 mg QD. Patients who remain on fluconazole and meet the target recovery criteria below can increase ruxolitinib dosing to 5 mg BID and subsequently 10 mg BID.

Group II: Expansion Phase: RuxolitinibExperimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ruxolitinib

2018

Completed Phase 3

~1140

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor

1,933 Previous Clinical Trials

2,299,676 Total Patients Enrolled

Incyte CorporationIndustry Sponsor

364 Previous Clinical Trials

55,116 Total Patients Enrolled

Ramzi Abboud, M.D.Principal InvestigatorWashington University School of Medicine

1 Previous Clinical Trials

55 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What adverse effects are associated with Ruxolitinib?

"Ruxolitinib's safety was assessed at a 2 due to its Phase 2 trial status, which implies that while there is evidence of safety, efficacy has yet to be studied."

Answered by AI

Are there ongoing opportunities for patients to partake in this trial?

"Clinicaltrials.gov affirms that this medical study is no longer recruiting participants, despite having been first posted on October 31st 2023 and last updated on August 18th of the same year. However, there are presently 164 other clinical trials actively seeking candidates for their studies."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Ruxolitinib for the Prophylaxis of Graft-Versus-Host Disease and Cytokine Release Syndrome After T-cell Replete Haploidentical Peripheral Blood Hematopoietic Cell Transplantation

2024. "Ruxolitinib for the Prophylaxis of Graft-Versus-Host Disease and Cytokine Release Syndrome After T-cell Replete Haploidentical Peripheral Blood Hematopoietic Cell Transplantation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06008808.

All > Graft Vs Host Disease