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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

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 60 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.

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot tolerate certain medications for virus and pneumonia prevention during my initial cancer treatment.

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I cannot take certain stomach medicines due to severe stomach issues or reactions.

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My leukemia is identified as Mature B-cell (Burkitt's).

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My leukemia is not Philadelphia chromosome positive.

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My leukemia has a mutation resistant to standard treatments.

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I have HIV, Hepatitis B, or Hepatitis C.

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I do not have any infections or conditions that could affect the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

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 • 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

Thrombocytosis

Upper respiratory tract infection

Hypercholesterolaemia

Haematoma

Dyslipidaemia

Pain in extremity

Abdominal discomfort

Diarrhoea

Dyspepsia

Vomiting

Blood lactate dehydrogenase increased

Memory impairment

Dyspnoea

Tinnitus

Osteoarthritis

Leukocytosis

Thrombocytopenia

Flatulence

Nausea

Sinusitis

Basal cell carcinoma

Neuropathy peripheral

Hyperuricaemia

Paraesthesia

Bronchitis

Cystitis

Blood creatine phosphokinase increased

Skin ulcer

Abdominal pain upper

Pulmonary embolism

Pneumonia

Influenza

Myalgia

Urinary tract infection

Depression

Acute pulmonary oedema

Peripheral artery thrombosis

Vertigo

Night sweats

Intervertebral disc protrusion

Urethral stenosis

Ureterolithiasis

Localised infection

Pericardial effusion

Acute myocardial infarction

Syncope

Gastrooesophageal reflux disease

General physical health deterioration

Atrial fibrillation

Cardiac disorder

Mitral valve incompetence

Vertigo positional

Retinal artery occlusion

Visual acuity reduced

Gastrointestinal haemorrhage

Oesophageal varices haemorrhage

Lower respiratory tract infection

Pyelonephritis

Respiratory tract infection

Sepsis

Tendon rupture

Ulna fracture

Weight decreased

Decreased appetite

Hyponatraemia

Blast cell crisis

Bone marrow tumour cell infiltration

Lung adenocarcinoma

Metastases to spine

Myelofibrosis

Prostatic adenoma

Squamous cell carcinoma of skin

Nephrolithiasis

Gamma-glutamyltransferase increased

Haematocrit increased

Musculoskeletal pain

Ischaemic stroke

Diabetes mellitus

100%

80%

60%

40%

20%

Study treatment Arm

All Crossover Patients

Best Available Therapy

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 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.

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

0 / 9Eligibility criteria met