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Ruxolitinib for Graft-Versus-Host Disease Prevention

Phase 1

Recruiting

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

No Placebo-Only Group

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

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

Haematoma

Dyslipidaemia

Pain in extremity

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

Paraesthesia

Bronchitis

Cystitis

Blood creatine phosphokinase increased

Skin ulcer

Abdominal pain upper

Pulmonary embolism

Pneumonia

Influenza

Myalgia

Urinary tract infection

Depression

Acute pulmonary oedema

Peripheral artery thrombosis

Vertigo

Night sweats

Intervertebral disc protrusion

Urethral stenosis

Ureterolithiasis

Localised infection

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~1170

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