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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 42 days

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%

Fatigue

36%

Headache

28%

COVID-19

24%

Rash

24%

Diarrhoea

24%

Arthralgia

24%

Abdominal pain

20%

Pain in extremity

20%

Cough

20%

Dyspnoea

16%

Lipase increased

16%

Back pain

16%

Sinusitis

16%

Oropharyngeal pain

16%

Hypertension

12%

Pyrexia

12%

Vomiting

12%

Dry mouth

12%

Constipation

12%

Insomnia

12%

Non-cardiac chest pain

12%

Gastrooesophageal reflux disease

12%

Nausea

12%

Fall

12%

Aspartate aminotransferase increased

12%

Amylase increased

12%

Dizziness

Abdominal pain upper

Myalgia

Neutrophil count decreased

Anxiety

Platelet count decreased

Pruritus

Thrombocytopenia

Hypokalaemia

Oedema peripheral

Alanine aminotransferase increased

Upper respiratory tract infection

Pleural effusion

Rhinorrhoea

Memory impairment

Flank pain

Night sweats

Muscular weakness

Alopecia

COVID-19 pneumonia

Neuroendocrine tumour

Palpitations

Pelvic infection

Meniscus injury

Brain stem infarction

Chronic obstructive pulmonary disease

Urinary tract infection

Nasal congestion

Hot flush

100%

80%

60%

40%

20%

Study treatment Arm

Cohort A

Cohort C

Cohort B

Awards & Highlights

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: 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