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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I have been newly diagnosed with a specific type of leukemia (B-precursor ALL).
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My cancer has a 'Ph-like' signature.
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I completed a 4-drug chemotherapy regimen with spinal injections as recommended.
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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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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
Secondary outcome measures
Event-free survival rate
Overall survival rate
Rate of participants that are minimal residual disease (MRD) negative at end of induction therapy
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%
Dyslipidaemia
7%
Pain in extremity
7%
Haematoma
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%
Paraesthesia
3%
Cystitis
3%
Bronchitis
3%
Blood creatine phosphokinase increased
3%
Skin ulcer
3%
Abdominal pain upper
3%
Pulmonary embolism
3%
Pneumonia
3%
Influenza
3%
Myalgia
3%
Urinary tract infection
3%
Depression
2%
Localised infection
2%
Intervertebral disc protrusion
2%
Urethral stenosis
2%
Night sweats
2%
Acute pulmonary oedema
2%
Vertigo
2%
Peripheral artery thrombosis
2%
Ureterolithiasis
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
1,004 Previous Clinical Trials
819,762 Total Patients Enrolled
Incyte CorporationIndustry Sponsor
365 Previous Clinical Trials
55,174 Total Patients Enrolled
Wendy Stock, MDPrincipal InvestigatorUniversity of Chicago
8 Previous Clinical Trials
1,335 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken strong CYP3A4 inhibitors recently.My leukemia was Ph+ at diagnosis.I have been newly diagnosed with a specific type of leukemia (B-precursor ALL).My cancer has a 'Ph-like' signature.I am allergic to medications similar to ruxolitinib.My cancer has specific genetic changes targeted by Jak inhibitors.I completed a 4-drug chemotherapy regimen with spinal injections as recommended.I am between 18 and 39 years old.My liver and kidney functions are within normal ranges.I am mostly self-sufficient and can carry out daily activities.My leukemia is of the Burkitt type.I do not have any unmanaged ongoing illnesses.I have another active cancer besides non-melanoma skin cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Ruxolitinib
Awards:
This trial has 3 awards, including:- Approved for 60 Other Conditions - This treatment demonstrated efficacy for 60 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
May I join the cohort participating in this research?
"In order to qualify for this clinical trial, applicants must be between 18 and 39 years old with a diagnosis of acute lymphocytic leukemia (L1). The study is looking to enroll approximately 15 people."
Answered by AI
Are there any openings for this research endeavor?
"Affirmative. Clinicaltrials.gov has revealed that this research initiative, which was launched on May 28th 2019, is presently seeking participants. This trail requires 15 individuals at a single medical centre to complete the study."
Answered by AI
Is the accepted age range for this experiment limited to those below 85 years of age?
"This research project is open to those aged 18-39 years old."
Answered by AI
How many volunteers have been accepted into this research experiment?
"Indeed, clinicaltrials.gov confirms that this medical experiment is actively recruiting participants; it was first posted on May 28th 2019 and the latest update occurred on September 14th 2021. The research team require 15 volunteers from 1 site."
Answered by AI
What is the most typical purpose for administering Ruxolitinib?
"Ruxolitinib is primarily deployed to treat leukemia, but can also be an effective medication for a range of other maladies such as synovitis, ophthalmia, sympathetic disorders and certain lung cancers."
Answered by AI
What research has been conducted previously on Ruxolitinib?
"Currently, 1996 Ruxolitinib-related medical trials are underway worldwide; with 434 at the Phase 3 stage. Changsha, Hunan is hosting a significant portion of these studies but there is an abundance of other sites also running clinical experiments on this drug across 63991 locations."
Answered by AI
What potential risk factors have been identified in connection with Ruxolitinib?
"Due to limited efficacy data, the safety of Ruxolitinib was given a score of 1 on our team's scale. This is the result of it being a Phase 1 trial."
Answered by AI
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