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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
Must not have
Calculated creatinine clearance or radioisotope glomerular filtration rate < 70 mL/min/1.73 m^2
Trisomy 21 (Down syndrome)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
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.
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.
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 belowSelect...
I finished a 4-drug treatment and had a test for remaining cancer cells.
Select...
I am between 2 and 21 years old and live in Canada.
Select...
I was diagnosed between the ages of 1 and 21.
Select...
My leukemia is high-risk and was identified as Ph-like at diagnosis.
Select...
My cancer has been analyzed for specific gene changes.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My kidney function, measured by creatinine clearance, is below 70 mL/min.
Select...
I have Down syndrome.
Select...
My leukemia is BCR-ABL1 positive.
Select...
I am HIV positive.
Select...
My liver enzyme (ALT) levels are five times higher than normal.
Select...
I have only received hydroxyurea or steroids before my main cancer treatment.
Select...
I have been diagnosed with cirrhosis.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Side effects data
From 2020 Phase 3 trial • 149 Patients • NCT0203803633%
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
9%
Thrombocytosis
9%
Upper respiratory tract infection
9%
Hypercholesterolaemia
7%
Haematoma
7%
Dyslipidaemia
7%
Pain in extremity
7%
Abdominal discomfort
7%
Diarrhoea
7%
Dyspepsia
7%
Vomiting
7%
Blood lactate dehydrogenase increased
7%
Memory impairment
7%
Dyspnoea
5%
Tinnitus
5%
Osteoarthritis
5%
Leukocytosis
5%
Thrombocytopenia
5%
Flatulence
5%
Nausea
5%
Sinusitis
5%
Basal cell carcinoma
5%
Neuropathy peripheral
5%
Hyperuricaemia
3%
Cystitis
3%
Blood creatine phosphokinase increased
3%
Bronchitis
3%
Paraesthesia
3%
Skin ulcer
3%
Abdominal pain upper
3%
Pulmonary embolism
3%
Pneumonia
3%
Influenza
3%
Myalgia
3%
Urinary tract infection
3%
Depression
2%
Night sweats
2%
Peripheral artery thrombosis
2%
Vertigo
2%
Intervertebral disc protrusion
2%
Urethral stenosis
2%
Acute pulmonary oedema
2%
Ureterolithiasis
2%
Localised infection
2%
Pericardial effusion
2%
Acute myocardial infarction
2%
Syncope
2%
Gastrooesophageal reflux disease
2%
General physical health deterioration
2%
Atrial fibrillation
2%
Cardiac disorder
2%
Mitral valve incompetence
2%
Vertigo positional
2%
Retinal artery occlusion
2%
Visual acuity reduced
2%
Gastrointestinal haemorrhage
2%
Oesophageal varices haemorrhage
2%
Lower respiratory tract infection
2%
Pyelonephritis
2%
Respiratory tract infection
2%
Sepsis
2%
Tendon rupture
2%
Ulna fracture
2%
Weight decreased
2%
Decreased appetite
2%
Hyponatraemia
2%
Blast cell crisis
2%
Bone marrow tumour cell infiltration
2%
Lung adenocarcinoma
2%
Metastases to spine
2%
Myelofibrosis
2%
Prostatic adenoma
2%
Squamous cell carcinoma of skin
2%
Nephrolithiasis
2%
Gamma-glutamyltransferase increased
2%
Haematocrit increased
2%
Musculoskeletal pain
2%
Ischaemic stroke
2%
Diabetes mellitus
100%
80%
60%
40%
20%
0%
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
Leucovorin Calcium
2011
Completed Phase 3
~12500
Methotrexate
2019
Completed Phase 4
~4400
Pegaspargase
2005
Completed Phase 3
~9260
Vincristine Sulfate
2005
Completed Phase 3
~10270
Thioguanine
2012
Completed Phase 4
~10830
Mercaptopurine
2012
Completed Phase 4
~12550
Prednisone
2014
Completed Phase 4
~2500
Ruxolitinib
2018
Completed Phase 3
~1140
Cyclophosphamide
2010
Completed Phase 4
~2320
Cytarabine
2016
Completed Phase 3
~3330
Dexamethasone
2007
Completed Phase 4
~2640
Doxorubicin
2012
Completed Phase 3
~8030
Find a Location
Who is running the clinical trial?
Incyte CorporationLead Sponsor
382 Previous Clinical Trials
56,881 Total Patients Enrolled
20 Trials studying Leukemia
1,455 Patients Enrolled for Leukemia
Children's Oncology GroupNETWORK
457 Previous Clinical Trials
239,659 Total Patients Enrolled
171 Trials studying Leukemia
103,071 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- My kidney function, measured by creatinine clearance, is below 70 mL/min.I finished a 4-drug treatment and had a test for remaining cancer cells.I am not able to have children or I agree to use birth control during the study.I am between 2 and 21 years old and live in Canada.I have Down syndrome.My leukemia is BCR-ABL1 positive.I was diagnosed between the ages of 1 and 21.My leukemia is high-risk and was identified as Ph-like at diagnosis.I am HIV positive.My cancer has been analyzed for specific gene changes.My liver enzyme (ALT) levels are five times higher than normal.I have only received hydroxyurea or steroids before my main cancer treatment.I have been diagnosed with cirrhosis.
Research Study Groups:
This trial has the following groups:- Group 1: Ruxolitinib in combination with chemotherapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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