ABL001 Combo Therapy for Leukemia
Trial Summary
Will I have to stop taking my current medications?
The trial requires that certain medications be stopped before starting the study. Specifically, any TKI therapy must be discontinued for 5 half-lives before starting the trial, and other chemotherapy must be stopped 2 weeks prior, except for certain exceptions like steroids. Additionally, medications that strongly affect certain liver enzymes should be stopped unless medically necessary, in which case a review with the study investigator is needed.
What data supports the effectiveness of the drug ABL001 Combo Therapy for Leukemia?
The drug dasatinib, a component of the ABL001 Combo Therapy, is effective in treating chronic myeloid leukemia and Philadelphia chromosome-positive acute lymphoblastic leukemia, especially in patients who are resistant or intolerant to other treatments like imatinib. Additionally, asciminib, another component, has shown favorable results in patients with chronic myeloid leukemia in clinical trials.12345
What safety data exists for ABL001 (Asciminib) and Dasatinib (Sprycel) in humans?
Asciminib has shown favorable safety in patients with chronic myeloid leukemia in clinical trials. Dasatinib, while effective, can cause side effects like myelosuppression (reduced bone marrow activity) and pleural effusions (fluid around the lungs), but dose optimization has helped reduce these issues.12346
What makes the ABL001 Combo Therapy for Leukemia unique?
The ABL001 Combo Therapy is unique because it combines ABL001 (asciminib), an allosteric inhibitor that targets a different site on the BCR-ABL1 protein than traditional drugs, with dasatinib and prednisone. This combination aims to overcome resistance seen with other treatments by using different mechanisms to inhibit the cancer-driving protein, potentially leading to more effective disease control.15789
What is the purpose of this trial?
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
Research Team
Marlise R Luskin, MD
Principal Investigator
Dana-Farber Cancer Institute
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive ABL001, Dasatinib, and Prednisone. Blinatumomab is introduced from cycle 2. Dose escalation follows a 3+3 scheme to determine the recommended phase 2 dose.
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- ABL001
- Dasatinib
- Prednisone
ABL001 is already approved in United States, European Union for the following indications:
- Chronic myeloid leukemia (CML) in patients with a resistance or intolerance to two or more tyrosine kinase inhibitors
- Chronic myeloid leukemia (CML) in patients with a resistance or intolerance to two or more tyrosine kinase inhibitors
Find a Clinic Near You
Who Is Running the Clinical Trial?
Marlise R. Luskin
Lead Sponsor
Marlise Luskin, MD
Lead Sponsor
Novartis
Industry Sponsor
Vasant Narasimhan
Novartis
Chief Executive Officer since 2018
MD from Harvard Medical School, Bachelor's in Biological Sciences from University of Chicago, Master's in Public Policy from John F. Kennedy School of Government
Shreeram Aradhye
Novartis
Chief Medical Officer since 2022
MD from Yale University, MSc in Clinical Epidemiology from University of Pennsylvania