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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 85 days

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 85 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~85 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 85 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Maximum tolerated dose (MTD) of ABL001

Secondary outcome measures

Percentage for Participants Achieving Hematologic Remission

Percentage of participants achieving a minimal residual disease (MRD)-negative CR by flow cytometry

Percentage of participants achieving cytogenetic response

+1 more

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

~1210

Prednisone

2014

Completed Phase 4

~2370

Dasatinib

2012

Completed Phase 3

~2320

ABL001

2016

Completed Phase 1

~40

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Marlise R. LuskinLead Sponsor

Marlise Luskin, MDLead Sponsor

NovartisIndustry Sponsor

1,611 Previous Clinical Trials

2,720,995 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the maximum number of participants being accepted in this medical research project?

"34 eligible participants are needed to partake in this trial, which can be accessed at Beth Israel Deaconess Medical Center (Boston) and University of Chicago Comprehensive Cancer Centre (Chicago)."

Answered by AI

Is ABL001 secure for patients to use?

"Given the early stage of research, ABL001 received a score of 1. While there is limited data supporting efficacy and safety, further clinical trials will work to better understand its benefits."

Answered by AI

What medical applications is ABL001 commonly employed for?

"ABL001 is a viable treatment option for thyroiditis, ulcerative colitis and certain types of malignant neoplasms."

Answered by AI

What other research endeavors have been conducted surrounding ABL001?

"ABL001 was piloted in 2001 at Providence Cancer Center, located at the Providence Portland Medical Centre. To date, 735 completed clinical trials have been conducted with an additional 400 studies running currently across Boston, Massachusetts."

Answered by AI

Is recruitment for this investigation still underway?

"The data from clinicaltrials.gov indicates that this medical investigation is still in search of qualified patients. This trial was initially published on July 24th 2018 and most recently updated on December 27th 2021."

Answered by AI

How many locations are hosting this trial's operations?

"This medical trial is now recruiting patients at 6 different sites, including three cities in the United States (Boston, Chicago and New york) plus 3 additional locations. To reduce travel costs, it is important to select a site close by if you decide to participate."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

ABL001 + Dasatinib + Prednisone + Blinatumomab in BCR-ABL+ B-ALL or CML

Marlise Luskin, MD 2018. "ABL001 + Dasatinib + Prednisone + Blinatumomab in BCR-ABL+ B-ALL or CML". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03595917.

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