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Ruxolitinib + Chemotherapy for Acute Lymphoblastic Leukemia

Phase 1
Recruiting
Led By Wendy Stock, MD
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Newly diagnosed de novo B-precursor acute lymphoblastic leukemia (ALL) as determined by World Health Organization (WHO) criteria with unequivocal diagnosis of precursor B ALL
"Ph-like" signature as determined by low density micro-array (LDA) card
Must not have
Use of potent CYP3A4 inhibitors within 5 half-lives before the first dose of the study drug
Ph+ ALL at time of diagnosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights

Summary

This trial will test the safety of a new drug when added to standard chemotherapy for young people with a specific type of leukemia.

Who is the study for?
This trial is for adolescents and young adults aged 18-40 with newly diagnosed Ph-like acute lymphoblastic leukemia (ALL). Participants must have completed a specific chemotherapy regimen, have normal organ function, and agree to use contraception. Excluded are those with other active cancers, certain heart or psychiatric conditions, pregnant or breastfeeding women, and individuals on strong CYP3A4 inhibitors.
What is being tested?
The study tests the safety of adding ruxolitinib to a standard multi-drug chemotherapy regimen in treating Ph-like ALL. The goal is to determine if this combination improves outcomes for patients who fit the trial's criteria.
What are the potential side effects?
Potential side effects include risks associated with chemotherapy such as nausea, hair loss, increased infection risk due to low blood cell counts; ruxolitinib may cause birth defects if used during pregnancy and can lead to allergic reactions in some people.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been newly diagnosed with a specific type of leukemia (B-precursor ALL).
Select...
My cancer has a 'Ph-like' signature.
Select...
I completed a 4-drug chemotherapy regimen with spinal injections as recommended.
Select...
I am between 18 and 39 years old.
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My liver and kidney functions are within normal ranges.
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I am mostly self-sufficient and can carry out daily activities.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I haven't taken strong CYP3A4 inhibitors recently.
Select...
My leukemia was Ph+ at diagnosis.
Select...
I am allergic to medications similar to ruxolitinib.
Select...
My leukemia is of the Burkitt type.
Select...
I do not have any unmanaged ongoing illnesses.
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I have another active cancer besides non-melanoma skin cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Feasibility of adding ruxolitinib to a standard-of-care pediatric-based chemotherapy regimen in adolescents and young adult patients as determined by rate of side effects seen when combination is given

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
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: RuxolitinibExperimental Treatment13 Interventions
Participants will receive ruxolitinib in addition to standard chemotherapy. Standard Chemotherapy Consists of: * Remission consolidation therapy (lasting 8 weeks) * Interim Maintenance (lasting 8 weeks) * Delayed Intensification (lasting 8 weeks * Maintenance Therapy (12 week courses/84 day cycles lasting 2-3 years) Prior to study entry, patients must have completed a 4-drug induction therapy regimen with intrathecal chemotherapy (modified Berlin-Frankfurt-Münster (aBFM) regimen or equivalent) as per the institution standard of care.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pegaspargase
FDA approved
Ruxolitinib
FDA approved
Cytarabine
FDA approved
Vincristine
FDA approved
Rituximab
FDA approved
Dexamethasone
FDA approved
Doxorubicin
FDA approved
Tioguanine
FDA approved
Mercaptopurine
FDA approved
Cyclophosphamide
FDA approved

Find a Location

Who is running the clinical trial?

University of ChicagoLead Sponsor
1,034 Previous Clinical Trials
753,679 Total Patients Enrolled
Incyte CorporationIndustry Sponsor
382 Previous Clinical Trials
57,037 Total Patients Enrolled
Wendy Stock, MDPrincipal InvestigatorUniversity of Chicago
8 Previous Clinical Trials
1,335 Total Patients Enrolled

Media Library

Ruxolitinib Clinical Trial Eligibility Overview. Trial Name: NCT03571321 — Phase 1
Acute Lymphoblastic Leukemia Research Study Groups: Ruxolitinib
Acute Lymphoblastic Leukemia Clinical Trial 2023: Ruxolitinib Highlights & Side Effects. Trial Name: NCT03571321 — Phase 1
Ruxolitinib 2023 Treatment Timeline for Medical Study. Trial Name: NCT03571321 — Phase 1
~4 spots leftby Sep 2026
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