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Tyrosine Kinase Inhibitor

ABL001 Combo Therapy for Leukemia

Phase 1
Recruiting
Led By Marlise R. Luskin, MD
Research Sponsored by Marlise R. Luskin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must have cytopathologically confirmed CD19+ BCR-ABL1+ acute leukemia (B-cell ALL, mixed phenotype acute leukemia, or CML in lymphoid blast crisis with ≥ 5% lymphoblasts)
Participants who have not received standard intensive induction chemotherapy and are aged 18 to 49 years and unfit due to co-morbidity or other factors to receive intensive chemotherapy
Must not have
History of pulmonary arterial hypertension
Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drug
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 42 days
Awards & highlights

Summary

This trial is testing ABL001 in combination with dasatinib and prednisone as a possible treatment for B-cell Acute Lymphoblastic Leukemia (BCR-ABL+ B-ALL) or Chronic Myeloid Leukemia (CML) in lymphoid blast crisis.

Who is the study for?
Adults with BCR-ABL+ B-cell ALL or CML in lymphoid blast crisis, who are unsuitable for standard chemotherapy due to age, comorbidities, or relapse. Participants must have normal organ function and agree to use effective contraception. Excluded are those suitable for standard therapy, with certain mutations or recent treatments, active infections like hepatitis/HIV, significant heart/lung issues, gastrointestinal disorders affecting drug absorption.
What is being tested?
The trial is testing ABL001 combined with dasatinib (Sprycel®) and prednisone as a treatment option for Philadelphia chromosome positive Acute Lymphoblastic Leukemia (Ph+ ALL) and Chronic Myeloid Leukemia (CML) in blast crisis phase. The study aims to enroll 25-40 people to assess the effectiveness of this drug combination.
What are the potential side effects?
Potential side effects may include changes in blood counts leading to increased risk of infections or bleeding; liver problems; pancreatitis; nausea; fatigue; muscle pain; allergic reactions. Specific side effects related to each medication can vary but will be monitored closely throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My leukemia is confirmed to be CD19+ and BCR-ABL1+.
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I am 18-49, have not had intense chemo, and cannot handle it due to health issues.
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I am over 18 and my disease did not respond to at least one round of intense chemotherapy.
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I am 50 or older and have not had intensive chemotherapy.
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I cannot or do not want to undergo strong chemotherapy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of high blood pressure in the lungs.
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I have a stomach or intestine problem that affects how I absorb medicine.
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I have liver disease.
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I am HIV positive.
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I cannot follow a treatment plan that requires taking pills.
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I have severe fluid buildup in my chest affecting my breathing.
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My cancer has the ABL T315I mutation.
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I need extra oxygen, help breathing, drugs to support my blood pressure, or kidney dialysis.
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I have been treated for ALL or CML with dasatinib or asciminib.
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I have a history of or currently have pancreatitis or any pancreatic disease.
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I am ready and able to undergo strong chemotherapy.
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I do not have any severe illnesses or social situations that would prevent me from following the study's requirements.
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I have a serious bleeding disorder not related to my leukemia.
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I am currently being treated for another cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~42 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 42 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Maximum tolerated dose (MTD) of ABL001

Side effects data

From 2024 Phase 3 trial • 56 Patients • NCT04666259
36%
Headache
36%
Fatigue
28%
COVID-19
24%
Abdominal pain
24%
Rash
24%
Diarrhoea
24%
Arthralgia
20%
Cough
20%
Pain in extremity
20%
Dyspnoea
16%
Hypertension
16%
Back pain
16%
Sinusitis
16%
Lipase increased
16%
Oropharyngeal pain
12%
Constipation
12%
Dry mouth
12%
Aspartate aminotransferase increased
12%
Insomnia
12%
Fall
12%
Gastrooesophageal reflux disease
12%
Nausea
12%
Vomiting
12%
Pyrexia
12%
Amylase increased
12%
Dizziness
12%
Non-cardiac chest pain
8%
Alanine aminotransferase increased
8%
Rhinorrhoea
8%
Myalgia
8%
Abdominal pain upper
8%
Oedema peripheral
8%
Pruritus
8%
Anxiety
8%
Upper respiratory tract infection
8%
Neutrophil count decreased
8%
Hypokalaemia
8%
Pleural effusion
8%
Thrombocytopenia
8%
Platelet count decreased
4%
Palpitations
4%
Muscular weakness
4%
Night sweats
4%
Nasal congestion
4%
Alopecia
4%
Hot flush
4%
Pelvic infection
4%
Neuroendocrine tumour
4%
Urinary tract infection
4%
COVID-19 pneumonia
4%
Meniscus injury
4%
Brain stem infarction
4%
Flank pain
4%
Chronic obstructive pulmonary disease
4%
Memory impairment
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort A
Cohort B
Cohort C

Trial Design

1Treatment groups
Experimental Treatment
Group I: ABL001, Dasatinib, Prednisone, BlinatumomabExperimental Treatment4 Interventions
- Dose escalation will occur conventional Fibonocci 3+3 dose escalation scheme to determine a recommended phase 2 dose (RP2D) * Dasatinib-Fixed doses oral once a day per cycle * ABL001 is administered orally daily per cycle * Prednisone-Fixed doses oral once a day per cycle. --- Prednisone will be tapered and stop during cycle 2. * Blinatumomab - intravenous continuous infusion beginning no earlier than cycle 2 day 1 * Blinatumomab - Day 1-28 of each 42-day cycle, cycles 2-6, total of 5 cycles
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Blinatumomab
2014
Completed Phase 3
~1230
Prednisone
2014
Completed Phase 4
~2500
Dasatinib
2012
Completed Phase 3
~2320
ABL001
2016
Completed Phase 3
~90

Find a Location

Who is running the clinical trial?

Marlise R. LuskinLead Sponsor
Marlise Luskin, MDLead Sponsor
NovartisIndustry Sponsor
1,624 Previous Clinical Trials
2,723,742 Total Patients Enrolled

Media Library

ABL001 (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03595917 — Phase 1
Acute Lymphoblastic Leukemia Research Study Groups: ABL001, Dasatinib, Prednisone, Blinatumomab
Acute Lymphoblastic Leukemia Clinical Trial 2023: ABL001 Highlights & Side Effects. Trial Name: NCT03595917 — Phase 1
ABL001 (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03595917 — Phase 1
~6 spots leftby Nov 2025
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