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Tyrosine Kinase Inhibitor
Triple Drug Therapy for Acute Lymphoblastic Leukemia
New York, NY
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
Must not have
Unable to tolerate anti-viral and anti-Pneumocystis jirovecii prophylaxis while on pre-phase and remission induction therapy
Unable to tolerate gastrointestinal prophylaxis therapy with sucralfate while on pre-phase and remission induction therapy or severe pre-existing GI disorder that requires PPI or H2 receptor antagonist therapy be uninterrupted
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
All Individual Drugs Already Approved
Approved for 100 Other Conditions
No Placebo-Only Group
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.
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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.
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I can take care of myself but might not be able to do heavy physical work.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I cannot tolerate certain medications for virus and pneumonia prevention during my initial cancer treatment.
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Select...
I cannot take certain stomach medicines due to severe stomach issues or reactions.
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Select...
My leukemia is identified as Mature B-cell (Burkitt's).
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Select...
My leukemia is not Philadelphia chromosome positive.
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Select...
My leukemia has a mutation resistant to standard treatments.
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Select...
I have HIV, Hepatitis B, or Hepatitis C.
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Select...
I do not have any infections or conditions that could affect the study.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Clinical response
Secondary study objectives
Complete Molecular Remission (CMR) rate
Side effects data
From 2020 Phase 3 trial • 149 Patients • NCT0203803623%
Pruritus
12%
Headache
9%
Diarrhoea
9%
Upper respiratory tract infection
8%
Fatigue
8%
Asthenia
8%
Thrombocytopenia
7%
Dizziness
7%
Night sweats
7%
Nausea
7%
Haematocrit increased
5%
Influenza
5%
Weight decreased
5%
Erythema
5%
Decreased appetite
5%
Leukocytosis
5%
Constipation
4%
Thrombocytosis
4%
Abdominal pain upper
4%
Hypertension
4%
Arthralgia
3%
Abdominal discomfort
3%
Oedema peripheral
3%
Bronchitis
3%
Myalgia
3%
Pain in extremity
3%
Cough
3%
Dyspnoea
3%
Epistaxis
3%
Tinnitus
3%
Nasopharyngitis
3%
Dyspepsia
1%
Abdominal pain
1%
Syncope
1%
Respiratory failure
1%
Extremity necrosis
1%
Anaemia
1%
Vertigo
1%
Atrial fibrillation
1%
Vomiting
1%
Gastrointestinal haemorrhage
1%
Cellulitis
1%
Pyrexia
1%
Blood lactate dehydrogenase increased
1%
Gamma-glutamyltransferase increased
1%
Weight increased
1%
Hyperuricaemia
1%
Depression
1%
Haematoma
1%
Neutropenia
1%
Muscle spasms
1%
Rectal haemorrhage
1%
Meningitis
1%
Pneumonia
1%
Septic shock
1%
Hyponatraemia
1%
Acute myeloid leukaemia
1%
Bladder transitional cell carcinoma
1%
Breast cancer
1%
Myelofibrosis
1%
Abdominal distension
1%
Flatulence
1%
Musculoskeletal pain
1%
Osteoarthritis
1%
Cardiac failure
1%
Renal failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Best Available Therapy
All Crossover Patients
Ruxolitinib
Awards & Highlights
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 100 Other Conditions
This treatment demonstrated efficacy for 100 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
Closest Location:Memorial Sloan Kettering Cancer Center· New York, NY· 478 miles
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,996 Previous Clinical Trials
602,333 Total Patients Enrolled
Incyte CorporationIndustry Sponsor
406 Previous Clinical Trials
66,744 Total Patients Enrolled
Novartis PharmaceuticalsIndustry Sponsor
2,959 Previous Clinical Trials
4,274,222 Total Patients Enrolled
Jae Park, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
15 Previous Clinical Trials
559 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 100 Other Conditions - This treatment demonstrated efficacy for 100 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.