Health TrialsbyHealthPanel

Topical Ruxolitinib in Acute Skin GVHD (Graft Versus Host Disease)

ConditionAcute Skin Graft Versus Host Disease (GVHD)
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age2-35
SponsorChildren's Hospital Medical Center, Cincinnati

About this trial

The purpose of this study is to see if ruxolitinib, a Janus Kinase (JAK) 1/2 inhibitor, is safe for people who have acute skin graft versus host disease (GVHD) following allogenic hematopoietic stem cell transplantation (HSCT).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥2 through age 35 years

Acute skin GVHD (any grade).

Underlying diagnosis of malignancy.

No concurrent systemic immune suppression to treat acute GVHD. This excludes agents like calcineurin inhibitors, mycophenolate mofetil, and abatacept which prevent acute GVHD and are not used for treatment as per clinical practice may continue.

Disqualifiers

Active uncontrolled skin infections.

History of allergic reactions to topical ruxolitinib.

Concomitant steroids or have received investigational therapies within the previous 30 days.

Trial design

Design model

Single group

Treatments tested in this trial

  • Ruxolitinib 1.5% cream

    Drug

    Ruxolitinib is a Janus Kinase (JAK) 1/2 inhibitor. JAKs are intracellular tyrosine kinases that play an important role in the development and function of immune cells that are involved in the pathogenesis of acute GVHD. For this study, ruxolitinib cream will be manufactured by Incyte and stored and distributed by the investigational pharmacy at Cincinnati Children's Hospital Medical Center (CCHMC) using standard operating procedures. Ruxolitinib 1.5% cream will be applied as a thin film topically twice a day to areas of erythroderma and pruritus. Participants and guardians will receive an informational instruction sheet describing the amount, frequency, and technique of applying the cream. Patients may continue to use standard of care GVHD prophylaxis and moisturizers.

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: RuxolitinibExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of patients with a clinical response at Day 7 (± 3 days)

Participants will be evaluated by monitoring the clinical response, tolerability and safety of topical ruxolitinib at Day 7 (± 3 days). Patients who respond by Day 7 (± 3 days) will continue treatment until resolution of symptoms or till Day 28 (± 3 days).

Time frame
From enrollment to Day 7 (± 3 days)
2

Number of patients with a clinical response at Day 28 (± 3 days)

Participants will be evaluated by monitoring the clinical response, tolerability and safety of topical ruxolitinib at Day 28 (± 3 days).

Time frame
From enrollment to Day 28 (± 3 days)

Secondary outcomes

1

Number of patients needing systemic immune suppression due to lack of response from progressive symptoms or adverse events secondary to topical ruxolitinib

Time frame
From enrollment to Day 28 (± 3 days)
2

Number of patients with a relapse of primary malignancy by 1 year post HSCT

Time frame
From enrollment to 1 year post HSCT
3

Blood ruxolitinib concentration levels at documented body surface area (BSA) applications and their association with adverse effects and relapse rates.

Time frame
Day 7 (± 3 days)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Children's Hospital Medical Center, Cincinnati

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: