Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT03595917

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

Led by Marlise Luskin, MD · Updated on 2025-11-04

40

Participants Needed

4

Research Sites

483 weeks

Total Duration

On this page

Sponsors

M

Marlise Luskin, MD

Lead Sponsor

N

Novartis

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research study is evaluating a drug called ABL001 taken in combination with dasatinib (Sprycel®) and prednisone (a steroid) as a possible treatment for B-cell Acute Lymphoblastic Leukemia that is BCR-ABL positive (BCR-ABL+ B-ALL) or Chronic Myeloid Leukemia (CML) in lymphoid blast crisis. BCR-ABL+ B-ALL is also called Philadelphia chromosome positive Acute Lymphoblastic Leukemia (Ph+ ALL). It is expected that 40-65 people will take part in this research study. * ABL001 * Dasatinib (Sprycel®) * Prednisone * Blinatumomab

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years and older
  • Confirmed diagnosis of CD19+ BCR-ABL1+ acute leukemia (B-cell ALL, mixed phenotype acute leukemia, or CML in lymphoid blast crisis with 5% lymphoblasts)
  • BCR-ABL1 positive status confirmed by FISH, karyotype analysis, or molecular testing
  • Patients with asymptomatic central nervous system disease may be included
  • For dose escalation: Not suitable for or unwilling to receive standard intensive induction chemotherapy
  • For dose expansion: Eligible regardless of suitability for intensive chemotherapy
  • Participants aged 50 years or older who have not received standard intensive induction chemotherapy
  • Participants aged 18 to 49 years unfit for intensive chemotherapy due to comorbidities or other factors
  • ECOG performance status of 0 to 3, with status 3 allowed if related to disease
  • Normal organ function based on specific laboratory values
  • Agreement to use adequate contraception if of child-bearing potential
  • Ability to understand and sign informed consent and comply with study procedures
Not Eligible

You will not qualify if you...

  • For dose escalation: Suitable and willing to receive standard intensive induction chemotherapy
  • Known ABL T315I mutation
  • Prior treatment with dasatinib or ASCIMINIB for ALL or CML
  • Other TKI therapy not discontinued for 5 half-lives before study treatment
  • Chemotherapy (except steroids, hydroxyurea, ATRA, intrathecal chemo) within 2 weeks prior to study
  • Receiving other investigational agents for conditions other than ALL within 2 weeks prior to study
  • Gastrointestinal conditions affecting drug absorption
  • History of prior or concurrent malignancy requiring treatment affecting study assessment
  • Acute or chronic liver disease, including active hepatitis B or C
  • History of pulmonary arterial hypertension
  • Significant pleural effusions causing respiratory problems
  • Alcohol abuse needing medical treatment
  • History or current pancreatitis or pancreatic disease
  • Known HIV infection
  • Serious bleeding disorder unrelated to ALL
  • Use of certain medications affecting CYP enzymes or proton-pump inhibitors without PI approval
  • QTc interval >480 ms on baseline ECG
  • Major surgery within 2 weeks before starting study
  • Uncontrolled infections or unstable cardiovascular conditions
  • Psychiatric or social issues limiting compliance
  • Requirement for life-support measures
  • Pregnant or nursing women at screening

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 4 locations

1

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, United States, 60637

Actively Recruiting

2

Dana Farber Cancer Institute

Boston, Massachusetts, United States, 02115

Actively Recruiting

3

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02215

Actively Recruiting

4

Roswell Park Comprehensive Cancer Center

Buffalo, New York, United States, 14203

Actively Recruiting

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Research Team

M

Marlise R. Luskin, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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