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JAK Inhibitor

Ruxolitinib + Chemotherapy for Leukemia

Phase 2

Waitlist Available

Research Sponsored by Incyte Corporation

Eligibility Criteria Checklist

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

Must have

Completed a 4-drug Induction therapy regimen and had end-Induction minimal residual disease (MRD) assessed

Participant is 2 years to 21 years in Canada

Timeline

Screening 3 weeks

Treatment Varies

Follow Up part 2: assessed at 3 years

Awards & highlights

Study Summary

This trial is testing a new cancer drug, ruxolitinib, in combination with standard chemotherapy to treat B-cell acute lymphoblastic leukemia. The study will first find the best dose of ruxolitinib to use with chemotherapy, then test how well the combination works at that dose.

Who is the study for?

This trial is for children and young adults aged 1 to 21 with high-risk B-cell acute lymphoblastic leukemia that shows a specific genetic profile. Participants must have completed initial chemotherapy, not be pregnant or fathering a child, and cannot have certain other health conditions like Down syndrome or active hepatitis.Check my eligibility

What is being tested?

The study tests Ruxolitinib combined with standard chemotherapy in two parts: first finding the best dose of Ruxolitinib, then checking how well it works at that dose. It's for kids who've just been diagnosed and haven't had much treatment yet.See study design

What are the potential side effects?

Possible side effects include liver issues, infections due to low white blood cell counts, allergic reactions to medication components, nausea from chemo drugs, and potential increased bleeding risk due to low platelets.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I finished a 4-drug treatment and had a test for remaining cancer cells.

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I am between 2 and 21 years old and live in Canada.

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I was diagnosed between the ages of 1 and 21.

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My leukemia is high-risk and was identified as Ph-like at diagnosis.

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My cancer has been analyzed for specific gene changes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ part 2: assessed at 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~part 2: assessed at 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and part 2: assessed at 3 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Part 1: Safety/tolerability of ruxolitinib in combination with chemotherapy as measured by adverse events (AEs), vital signs, clinical laboratory tests, and echocardiograms

Part 2: Efficacy of ruxolitinib in combination with chemotherapy as measured by Event-free survival, defined as the percentage of patients alive without relapse, progression, or death at 3 years from study Day 1

Secondary outcome measures

Safety and tolerability of the combination treatment for subjects beginning treatment at the recommended dose for Part 2, as assessed by AEs, vital signs, clinical laboratory tests, and echocardiograms

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

1Treatment groups

Experimental Treatment

Group I: Ruxolitinib in combination with chemotherapyExperimental Treatment13 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pegaspargase

2005

Completed Phase 3

~9010

Leucovorin Calcium

2011

Completed Phase 3

~12290

Methotrexate

2013

Completed Phase 4

~3800

Vincristine Sulfate

2005

Completed Phase 3

~10110

Thioguanine

2012

Completed Phase 4

~10830

Mercaptopurine

2012

Completed Phase 4

~12330

Prednisone

2014

Completed Phase 4

~2370

Ruxolitinib

2018

Completed Phase 3

~1140

Cyclophosphamide

1995

Completed Phase 3

~3780

Cytarabine

2016

Completed Phase 3

~3310

Dexamethasone

2007

Completed Phase 4

~2590

Doxorubicin

2012

Completed Phase 3

~7940

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Incyte CorporationLead Sponsor

364 Previous Clinical Trials

54,994 Total Patients Enrolled

19 Trials studying Leukemia

1,384 Patients Enrolled for Leukemia

Children's Oncology GroupNETWORK

453 Previous Clinical Trials

237,529 Total Patients Enrolled

171 Trials studying Leukemia

103,101 Patients Enrolled for Leukemia

Sarah Tasian, MDStudy ChairChildren's Hospital of Philadelphia, Philadelphia, PA

1 Previous Clinical Trials

10 Total Patients Enrolled

1 Trials studying Leukemia

10 Patients Enrolled for Leukemia

Media Library

Ruxolitinib (JAK Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02723994 — Phase 2

Leukemia Research Study Groups: Ruxolitinib in combination with chemotherapy

Leukemia Clinical Trial 2023: Ruxolitinib Highlights & Side Effects. Trial Name: NCT02723994 — Phase 2

Ruxolitinib (JAK Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02723994 — Phase 2

Frequently Asked Questions

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

Does this medical trial accept participants aged fifty and over?

"To take part in this trial, participants must be between 1 Year and 21 Years of age. There is a total of 931 studies available for children under 18 whereas adults over 65 are eligible to join 2987 different clinical trials."

Answered by AI

Who are the eligible participants for this trial?

"Aged between 1 year and 21 years old, candidates affected by leukemia are eligible to apply for this trial. At present, the project is seeking 170 participants."

Answered by AI

What is the current scope of this clinical trial's implementation?

"At present, this clinical trial is recruiting from a total of 100 sites. Grand Rapids, Saint Louis and Birmingham are included in the list of locations alongside an additional hundred cities. To reduce travel burdens associated with participation in the study, it is encouraged to choose the nearest site possible."

Answered by AI

Has this research been done previously, or is it a groundbreaking endeavor?

"An extensive search reveals that Ruxolitinib is currently being vetted in a total of 2148 live trials across 87 different nations, with 3777 cities hosting the clinical studies. The first such study was conducted by Alfacell back in 1997 and involved 300 patients. Since then, 3939 investigations have been completed on this medication's efficacy and safety."

Answered by AI

What additional research has been conducted using Ruxolitinib?

"The first study of ruxolitinib began in 1997 at the Spectrum Health Hospital - Butterworth Campus. Now, there are a total of 3939 completed studies and an additional 2148 active trials occurring primarily around Grand Rapids, Michigan."

Answered by AI

Under what circumstances is Ruxolitinib typically prescribed?

"Ruxolitinib is an extensively used medication in the treatment of pheochromocytomas, however it may also be beneficial for managing eye diseases, ulcerative colitis and varicella-zoster virus acute retinal necrosis."

Answered by AI

Are there vacancies for participants in this experimental program?

"This research is still recruiting, according to clinicaltrials.gov. It was initially announced on September 30th 2016 and the details have been updated as recently as November 14th 2022."

Answered by AI

What is the size of the participant pool for this clinical investigation?

"Affirmative. Information found on clinicaltrials.gov elucidates that this medical trial, which was initially advertised on September 30th 2016, is currently recruiting patients. This study seeks 170 participants from 100 different sites in total."

Answered by AI

Does Ruxolitinib present any risks to those taking it as a medication?

"At Power, the safety of Ruxolitinib was judged to be a 2 because this is only in Phase 2 trials - meaning there are some results supporting its safety but none indicating efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Phase 2 Study of Ruxolitinib With Chemotherapy in Children With Acute Lymphoblastic Leukemia

2016. "A Phase 2 Study of Ruxolitinib With Chemotherapy in Children With Acute Lymphoblastic Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02723994.

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