Phase 1/2 FLAG-IDA, VEN and Asciminib in CML and Ph+ AML

NCT07604233 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: 2025-1873NCI-2026-03869
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of Phase 1b is to establish the safety of asciminib in combination with FLAG-Ida and venetoclax in patients with CML-MBP, CML-LBP, and Ph+ AML. The goal of Phase 2 is to learn if asciminib in combination with FLAG-Ida and venetoclax can help to control the disease.

Conditions

Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

• Safety and Adverse Events (AEs)

  Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

  Through study completion; an average of 1 year

Study Arms (2)

Treatment with FLAG-Ida + Venetoclax + Asciminib

EXPERIMENTAL

Drug: Fludarabine; Drug: Cytarabine; Drug: Idarubicin; Drug: Filgrastim; Drug: Venetoclax; Drug: Asciminib

Treatment with FLAG-Ida + Venetoclax + Asciminib + Blinatumomab

EXPERIMENTAL

Drug: Fludarabine; Drug: Cytarabine; Drug: Idarubicin; Drug: Filgrastim; Drug: Venetoclax; Drug: Asciminib; Drug: Blinatumomab

Interventions

Fludarabine DRUG

Given by IV

Also known as: Fludara

Treatment with FLAG-Ida + Venetoclax + Asciminib; Treatment with FLAG-Ida + Venetoclax + Asciminib + Blinatumomab

Cytarabine DRUG

Given by IV

Also known as: cytosine arabinoside

Treatment with FLAG-Ida + Venetoclax + Asciminib; Treatment with FLAG-Ida + Venetoclax + Asciminib + Blinatumomab

Idarubicin DRUG

Given by IV

Also known as: Idamycin and Idamycin PFS

Treatment with FLAG-Ida + Venetoclax + Asciminib; Treatment with FLAG-Ida + Venetoclax + Asciminib + Blinatumomab

Filgrastim DRUG

Given by injection

Also known as: Neupogen, Zarxio

Treatment with FLAG-Ida + Venetoclax + Asciminib; Treatment with FLAG-Ida + Venetoclax + Asciminib + Blinatumomab

Venetoclax DRUG

Given by orally

Also known as: Venclexta

Treatment with FLAG-Ida + Venetoclax + Asciminib; Treatment with FLAG-Ida + Venetoclax + Asciminib + Blinatumomab

Asciminib DRUG

Given orally

Also known as: Scemblix

Treatment with FLAG-Ida + Venetoclax + Asciminib; Treatment with FLAG-Ida + Venetoclax + Asciminib + Blinatumomab

Blinatumomab DRUG

Given by IV

Also known as: Blincyto

Treatment with FLAG-Ida + Venetoclax + Asciminib + Blinatumomab

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 to 70 years. Because no dosing or adverse event data are currently available on the use of the combination of FLAG-Ida with venetoclax and asciminib in patients \<18 years of age, children are excluded from this study.
• Newly diagnosed or relapsed/refractory:
• BCR::ABL1-rearranged CML in myeloid BP or Philadelphia chromosomepositive or BCR::ABL1-rearranged AML as defined by the WHO 2022 criteria23
• BCR::ABL1-rearranged CML in lymphoid BP.
• ECOG performance status ≤ 2.
• Adequate liver, cardiac, renal and pancreatic function as defined by the following criteria:
• Total serum bilirubin ≤ 1.5 x upper limit of normal (ULN), unless due to Gilbert's syndrome, hemolysis, or the underlying leukemia approved by the Principal Investigator (PI)
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 3 x ULN, unless due to the underlying leukemia approved by the PI
• Creatinine clearance ≥ 30 mL/min
• Serum amylase or lipase ≤ 1.5 x ULN
• Left ventricular ejection fraction ≥ 40%.
• For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
• Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
• Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
• Patients with a prior or concurrent malignancy whose natural history or treatment does not interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.

You may not qualify if:

• Patients who are receiving any other investigational agents used for the treatment of other cancers.
• Patients who have progressed on asciminib and/or a combination of intensive chemotherapy plus venetoclax. Patients with prior treatment with a hypomethylating agent and venetoclax will be eligible.
• Active grade III-V cardiac failure as defined by the New York Heart Association Criteria.
• Myocardial infarction, unstable angina, or stroke within 3 months prior to signing informed consent.
• Clinically significant atrial or ventricular arrhythmias (such as uncontrolled, clinically significant atrial fibrillation, ventricular tachycardia, ventricular fibrillation, or Torsades de pointes) as determined by the treating physician.
• Prolonged QTcF interval on pre-entry electrocardiogram (\> 470 msec) unless corrected after electrolyte replacement or approved by a cardiologist.
• History of acute pancreatitis within 6 months or medical history of chronic pancreatitis.
• Active serious infection not controlled by oral or intravenous antibiotics (e.g. persistent fever or lack of improvement despite antimicrobial treatment).
• Active secondary malignancy that in the investigator's opinion will shorten survival to less than one year.
• Treatment with any investigational antileukemic agent in the last 14 days before study entry, unless full recovery from side effects has occurred or patient has rapidly progressive disease judged to be life-threatening by the investigator. Prior recent treatment with corticosteroids, hydroxyurea, cytarabine (up to 2 g/m2 given for cytoreduction within the preceding 7 days) and/or an FDA-approved BCR::ABL1 TKI is permitted.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to the combination of FLAG-Ida, venetoclax, asciminib, or blinatumomab.
• Pregnant women are excluded from this study because study drugs have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with study drugs, breastfeeding should be discontinued.
• Patients with psychiatric illness/social situations that would limit compliance with study requirements.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

UT MD Anderson

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Website

MeSH Terms

Conditions

Leukemia, Myeloid

Interventions

fludarabine; fludarabine phosphate; Cytarabine; Idarubicin; Filgrastim; venetoclax; asciminib; blinatumomab

Condition Hierarchy (Ancestors)

Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Fadi Haddad, MD

  UT MD Anderson

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fadi Haddad, MD

CONTACT

713-402-9936; fhaddad@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2026
• First Posted: May 22, 2026
• Study Start (Estimated): November 30, 2026
• Primary Completion (Estimated): June 3, 2031
• Study Completion (Estimated): June 3, 2033
• Last Updated: May 22, 2026

Record last verified: 2026-05

Locations

US (1)