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Tyrosine Kinase Inhibitor
Triple Drug Therapy for Acute Lymphoblastic Leukemia
Phase 1
Waitlist Available
Led By Jae Park, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Confirmation of Philadelphia chromosome positivity by cytogenetics and/or molecular tests
ECOG performance status ≤ 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is testing the safety of a new combination of three oral drugs in people with Ph+ ALL. The drugs are dexamethasone, dasatinib, and ruxolitinib.
Who is the study for?
This trial is for adults aged 40 or older with newly diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ ALL) who haven't been treated before, except for specific prior therapies. Participants must be able to consent and have acceptable organ function. It's not open to those with HIV, Hepatitis B/C, certain heart conditions, other active cancers (with exceptions), uncontrolled infections, or severe pre-existing GI disorders.Check my eligibility
What is being tested?
The study tests a new drug combo: Ruxolitinib added to Dasatinib and Dexamethasone in Ph+ ALL patients. Starting with low doses of Ruxolitinib, the amount will increase gradually if no severe side effects occur. This helps find the safest effective dose for future research.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system, blood disorders like anemia or bleeding problems, liver issues signaled by yellowing skin or eyesight changes, kidney problems indicated by changes in urine output or swelling in legs and feet.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is confirmed to be Philadelphia chromosome positive.
Select...
I can take care of myself but might not be able to do heavy physical work.
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
Clinical response
Secondary outcome measures
Complete Molecular Remission (CMR) rate
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%
Blood creatine phosphokinase increased
3%
Cystitis
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%
Localised infection
2%
Urethral stenosis
2%
Night sweats
2%
Acute pulmonary oedema
2%
Intervertebral disc protrusion
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: Adding Ruxolitinib to Combination of Dasatinib + DexamethasoneExperimental Treatment3 Interventions
Steroid Pre-Phase (Days -6 to 0) Prednisone 10 mg/m2/day uptitrated to 60/mg/m2/day oral over seven days (capped at 120 mg/day).
Remission Induction (Days 1 to 84) Dasatinib 140 mg oral once daily. Days 1-84. Dexamethasone 10 mg/m2/day oral (capped at 20 mg/day). Days 1-24. Dexamethasone oral taper 10 mg/m2/day (capped at 20 mg/day) to off. Taper days 25-32. Off day 33.
Ruxolitinib phase I cohort dose oral. Days 1-84. Delivered BID. Delivered per the phase I dose cohort. Methotrexate (MTX) 12 mg Intrathecal (IT) for 4 doses on days 22, 43, 64, 85; +/- 3 days.
Post-Remission Induction Therapy (Starting Day 85) Allogeneic HSCT, at the discretion of the treating physician, at any point post-remission induction.
Or, post-remission induction (consolidation) therapy to be determined per the treating physician
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dasatinib
FDA approved
Dexamethasone
FDA approved
Ruxolitinib
FDA approved
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,933 Previous Clinical Trials
585,608 Total Patients Enrolled
Incyte CorporationIndustry Sponsor
364 Previous Clinical Trials
55,153 Total Patients Enrolled
Novartis PharmaceuticalsIndustry Sponsor
2,855 Previous Clinical Trials
4,197,338 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot tolerate certain medications for virus and pneumonia prevention during my initial cancer treatment.I cannot take certain stomach medicines due to severe stomach issues or reactions.My leukemia is identified as Mature B-cell (Burkitt's).I haven't had chemotherapy for at least 14 days.I haven't needed treatment for another cancer besides ALL in the last two years.My leukemia is not Philadelphia chromosome positive.My leukemia has a mutation resistant to standard treatments.I have HIV, Hepatitis B, or Hepatitis C.I am 18 or older with a specific type of leukemia (Ph+ ALL, Ph-like ALL, or CML in crisis).My cancer is confirmed to be Philadelphia chromosome positive.I agree to use effective birth control during and for 4 months after the study.My kidney function is reduced but not due to my cancer or its treatment.I do not have any infections or conditions that could affect the study.My organs work well, except for issues caused by my leukemia.I can take care of myself but might not be able to do heavy physical work.
Research Study Groups:
This trial has the following groups:- Group 1: Adding Ruxolitinib to Combination of Dasatinib + Dexamethasone
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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.
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.
Are there any other documented experiments that have tested Ruxolitinib?
"As of now, 692 clinical trials are investigating the efficacy and safety of Ruxolitinib with 160 in Phase 3. The city of Mishawaka, Indiana is a major centre for these studies but there are also 24767 other sites offering this trial around the world."
Answered by AI
Is enrollment still available for the trial participants?
"At present, no further candidates are being sought for this trial. The medical study was initially posted on June 29th 2015 and last modified on July 25th 2022. If you wish to pursue other clinical trials, 1498 all studies and 692 Ruxolitinib investigations are now recruiting patients."
Answered by AI
What is the enrolment capacity of this trial?
"Unfortunately, this trial is not currently looking for enrollees. The listing was first uploaded on June 29th 2015 and last updated July 25th 2022. If you're seeking out other available studies, there are 1498 active trials involving acute lymphoblastic leukemia (ALL) and 692 open clinical trials that incorporate ruxolitinib as part of their protocol."
Answered by AI
What kind of risks does Ruxolitinib pose to users?
"As this is an early-phase clinical trial, there is limited supporting evidence for the safety and efficacy of Ruxolitinib. Consequently, it received a score of 1 according to our team's evaluation at Power."
Answered by AI
What indications are most commonly addressed with Ruxolitinib?
"Ruxolitinib can be used to target and relieve symptoms of synovitis, ophthalmia, sympathetic disorders, as well as branch retinal vein occlusion."
Answered by AI
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