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Myeloid LeukemiaPhase 1/2NCT07604233

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

A Phase 1/2 study testing Fludarabine, Cytarabine and Idarubicin in people with Myeloid Leukemia, run by M.D. Anderson Cancer Center at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Myeloid Leukemia
What is being tested?
Fludarabine, Cytarabine and Idarubicin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
30 Nov 2026to 3 Jun 2033
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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.
  • Because the therapeutic agents used in this trial could potentially be teratogenic, women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation. This includes all female patients, up until the age of 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following:
  • Postmenopausal (no menses in greater than or equal to 12 consecutive months)
  • History of hysterectomy or bilateral salpingo-oophorectomy
  • Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy)
  • History of bilateral tubal ligation or another surgical sterilization procedure.
  • Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject/Partner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
  • Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of trial treatment
  • Ability to understand and the willingness to sign a written informed consent document.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Fadi Haddad, MD contact

346-234-4135

fhaddad@mdanderson.org

United States1 site

  • UT MD Anderson

    Houston, Texas, 77030

    Fadi Haddad, MD, 346-234-4135, fhaddad@mdanderson.org

    Fadi Haddad, MD

Other trials in United States

About this study

Official title: Phase I/II of the Combination of Fludarabine, Cytarabine, Idarubicin, G-CSF (FLAG-Ida) With Venetoclax and Asciminib in Patients With Advanced Phase Chronic Myeloid Leukemia and Philadelphia Chromosome-Positive Acute Myeloid Leukemia

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.

Read the detailed description

Primary Objectives:

Phase 1: To establish the safety of asciminib in combination with FLAG-Ida and venetoclax.

Phase 2: To evaluate the efficacy and toxicity of asciminib in combination with FLAG-Ida and venetoclax.

Primary Endpoints:

Phase 1: Incidence of dose limiting toxicities (DLTs) during the first cycle of study treatment.

Phase 2: Rate of complete response and rate of adverse events.

Secondary Objectives:

To assess the rates of conversion to CML-CP with this combination. To assess the cytogenetic and molecular response rates with this combination. To assess the survival outcomes with this combination.

Secondary Endpoints:

Rate of conversion to CML-CP defined as CR/CRi/CRh. Rates of CCyR, MMR, MR4, and MR4.5. Relapse-free survival (RFS) and overall survival.

Being tested
Fludarabine, Cytarabine, Idarubicin, Filgrastim, Venetoclax
Medical subject headings
Leukemia, Myeloid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FludarabineDrug

    Also called Fludara

    Given by IV

  • CytarabineDrug

    Also called cytosine arabinoside

    Given by IV

  • IdarubicinDrug

    Also called Idamycin and Idamycin PFS

    Given by IV

  • FilgrastimDrug

    Also called Neupogen, Zarxio

    Given by injection

  • VenetoclaxDrug

    Also called Venclexta

    Given by orally

  • AsciminibDrug

    Also called Scemblix

    Given orally

  • BlinatumomabDrug

    Also called Blincyto

    Given by IV

Study groups in NCT07604233
Study groupRoleWhat they receive
Treatment with FLAG-Ida + Venetoclax + AsciminibExperimentalNot described
Receives: Drug: Fludarabine; Drug: Cytarabine; Drug: Idarubicin; Drug: Filgrastim; Drug: Venetoclax; Drug: Asciminib
Treatment with FLAG-Ida + Venetoclax + Asciminib + BlinatumomabExperimentalNot described
Receives: Drug: Fludarabine; Drug: Cytarabine; Drug: Idarubicin; Drug: Filgrastim; Drug: Venetoclax; Drug: Asciminib; Drug: Blinatumomab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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) 6.0

    Measured: Through study completion; an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2026
  2. Study start30 Nov 2026 (estimated)
  3. Primary completion3 Jun 2031 (estimated)
  4. Study completion3 Jun 2033 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07604233
Sponsor's protocol ID
2025-1873
Other IDs
NCI-2026-03869
Status last verified
Oct 2026
First submitted
18 May 2026
Last updated
13 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Fludarabine, Cytarabine and Idarubicin in people with Myeloid Leukemia, run by M.D. Anderson Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Fadi Haddad, MD (346-234-4135, fhaddad@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and Adverse Events (AEs) (time frame: Through study completion; an average of 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07604233.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.

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