AzTrials
AzTrials

Acute LeukemiaPhase 4NCT05071482

Flumatinib Versus Imatinib Combined With Chemotherapy for de Novo Ph+ ALL

A Phase 4 study testing Flumatinib and Imatinib in people with Acute Leukemia, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

Compared with patients with philadelphia chromosome-negative Acute Lymphoblastic Leukemia (Ph- ALL), patients with Ph-positive (Ph+) ALL exhibit a comparatively poor prognosis. Fortunately, significant improvements have been found in response rates, disease-free survival (DFS), and overall survival (OS) for patients… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Acute Leukemia
What is being tested?
Flumatinib and Imatinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
1 siteChina
Study dates
16 Sep 2021to 16 Jan 2023
Phase
Phase 4
Are there results?
None posted in the registry

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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients aged 18 to 65 years, male or female;
  • Newly diagnosed Philadelphia chromosome positive(either t(9;22) and/or BCR-ABL positive and/ or FISH positive) acute lymphoblastic leukemia; Patients will be diagnosed according to morphologic,immunologic, cytogenetic and molecular(MICM) criteria, including bone marrow morphology, immunophenotype, cytogenetic and molecular genetic (BCR/ABL gene, qualitative and quantitative analysis) examination.
  • Eastern Cooperative Oncology Group (ECOG) Performance status 0-2;
  • Adequate end organ function as defined by: Total bilirubin ≤ 1.5 x upper limit of normal（ULN）; serum alanine aminotransferase (ALT) and serum aspartate aminotransferase (AST) ≤ 2.5 x ULN or ≤5 x ULN if leukemic involvement of the liver is present; Creatinine ≤ 1.5 x ULN; Serum amylase and lipase ≤ 1.5 x ULN; Alkaline phosphatase ≤ 2.5 x ULN unless considered tumor related; normal electrolytes: Potassium ≥ LLN; Magnesium ≥ LLN; Phosphorus ≥ LLN;
  • Cardiac color Doppler ultrasound ejection fraction ≥ 45%;
  • Subject has provided written informed consent prior to any screening procedure;

Who cannot join

  • Lymphoid blast crisis of chronic myelocytic leukemia (CML);
  • Previous or ongoing systemic anti-ALL therapy (including but not restricted to TKI and/or radiotherapy, except for appropriate pre-treatment);
  • Patients with clinical manifestations of central or extramedullary invasion of leukemia at diagnosis;
  • Identification of T315I mutation;
  • Concurrent participation in another clinical study with an investigational medical product;
  • Any concurrent severe and/or uncontrolled medical condition, which could, in the opinion of the investigator, compromise participation in the study;
Show all 15Show fewer
  • History of neurological or psychiatric disorders, including epilepsy or dementia;
  • Major surgery within 4 weeks or failure to recover from previous surgery;
  • Patients with a history of another primary malignancy that is currently clinically significant or currently requires active intervention;
  • Female patients who are pregnant or breast feeding or patients of childbearing potential and male patients whose sexual partner(s) are women of childbearing potential not willing to use a highly effective method of contraception;
  • Clinically significant, uncontrolled or active cardiovascular disease, specifically including, but not restricted to: any history of myocardial infarction, stroke, or revascularization; unstable angina or transient ischemic attack within 6 months prior to enrolment; congestive heart failure within 6 months prior to enrolment or left ventricular ejection fraction (LVEF) less than lower limit of normal per local institutional standards; history of clinically significant (as determined by the treating physician) atrial arrhythmia; any history of ventricular arrhythmia; any history of venous thromboembolism including deep venous thrombosis or pulmonary embolism;Uncontrolled hypertension;
  • Active known positive HIV serology;
  • Active serious infection not controlled by oral or intravenous antibiotics;
  • Patients with known allergies or contraindications to the study drug;
  • Patients with bleeding disorders unrelated to ALL.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Institute of Hematology & Blood Diseases Hospital

    Tianjin, 300020

Other trials in China

About this study

Official title: Flumatinib Versus Imatinib Combined With Multiagent Chemotherapy for Newly Diagnosed Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia: A Prospective, Open-label，Randomized，Multi-center Clinical Trial

Compared with patients with philadelphia chromosome-negative Acute Lymphoblastic Leukemia (Ph- ALL), patients with Ph-positive (Ph+) ALL exhibit a comparatively poor prognosis. Fortunately, significant improvements have been found in response rates, disease-free survival (DFS), and overall survival (OS) for patients with Ph+ ALL with the introduction of tyrosine kinase inhibitor (TKI) therapy to treatment regimens. Based on improvements in efficacy and tolerability, next-generation TKIs have been widely used in first-line treatment for chronic myeloid leukemia (CML). Flumatinib, a TKI with more potent binding affinity for BCR-ABL1 tyrosine kinase than imatinib, demonstrated higher rates of responses, faster and deeper responses in FESTnd trial, which suggested that flumatinib might show improved clinical efficacy for treating Ph+ ALL compared with imatinib. The investigators therefore hypothesized that the addition of flumatinib to combinatorial chemotherapy regimen would demonstrate greater efficacy compared with the prior use of imatinib in treating Ph+ ALL. This study explored the safety and efficacy of flumatinib versus imatinib when combined with multi-agent chemotherapy in patients with newly diagnosed Ph+ ALL.

Conditions
Acute Leukemia
Being tested
Flumatinib, Imatinib
Keywords
acute lymphoblastic leukemia, flumatinib
Medical subject headings
Precursor Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

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

  • FlumatinibDrug

    Flumatinib 600 mg qd will be given orally along with combination chemotherapy starting day 8 of induction chemotherapy. Flumatinib will be given continuously (if it's tolerable) for 2 years since achievement of complete remission (CR) as part of consolidation chemotherapy and maintenance therapy. Patients can receive allogeneic hematopoietic stem cell transplantation (HSCT),or patients in whom MCR was achieved within 3 months after treatment and continued until transplantation can receive autologous HSCT whenever possible during their first CR. Otherwise, they will finish the consolidation and maintenance chemotherapy.

  • ImatinibDrug

    Imatinib 600 mg qd will be given orally along with combination chemotherapy starting day 8 of induction chemotherapy. Imatinib will be given continuously (if it's tolerable) for 2 years since achievement of complete remission (CR) as part of consolidation chemotherapy and maintenance therapy. Patients can receive allogeneic hematopoietic stem cell transplantation (HSCT),or patients in whom MCR was achieved within 3 months after treatment and continued until transplantation can receive autologous HSCT whenever possible during their first CR. Otherwise, they will finish the consolidation and maintenance chemotherapy.

Study groups in NCT05071482
Study groupRoleWhat they receive
flumatinib armExperimental600 mg QD oral administration, fasting (2 hours before administration and 1 hour after administration).
Receives: Drug: Flumatinib
imatinib armActive comparator600 mg QD oral administration, with a meal
Receives: Drug: Imatinib

What is being measured

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

  1. Relapse free survival

    From the date of complete remission(CR) until the date of documented relapse or death due to any cause or the last follow-up day

    Measured: up to 24 months

Secondary outcomes (14)

  1. The rate of adverse events

    The incidence and severity of neutropenia, anemia, rash, hypophosphatemia, edema, limb pain, and other adverse events.

    Measured: through study completion, up to 24 months

  2. The composite CR rate

    Both CR and molecular CR are obtained at the end of induction

    Measured: up to 2 month

  3. The complete remission (CR) rate，CRi rate and overall remission rate（ORR）

    Measured: up to 2 month

  4. The minimal residual disease (MRD) negative rate by Flow Cytometry (FCM)

    Measured: up to 24 months

  5. The molecular CR rate

    Measured: up to 6 months

  6. The rate of primary induction failure(PIF)

    Measured: up to 6 months

  7. The duration of molecular CR

    Measured: up to 24 months

  8. The duration of CR

    Measured: up to 24 months

  9. Time to treatment failure

    Measured: up to 24 months

  10. The cumulative recurrence rate

    Measured: up to 24 months

  11. The CNS recurrence rate

    Measured: up to 24 months

  12. Event free survival(EFS)

    Measured: up to 24 months

  13. Overall survival(OS)

    Measured: up to 24 months

  14. The rate of interruption and discontinuation due to AE

    Measured: up to 24 months

Timeline

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

  1. First posted8 Oct 2021
  2. Study start16 Sep 2021
  3. Primary completion16 Jan 2023
  4. Study completion16 Jan 2023

Why it stopped: terminated

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05071482
Sponsor's protocol ID
IIT2021024
Status last verified
May 2024
First submitted
9 Sep 2021
Last updated
1 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Flumatinib and Imatinib in people with Acute Leukemia, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.

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 6 inclusion and 15 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: stopped early, as of the sponsor's last update on 1 May 2025. 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 China. 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 phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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

Are results available for this study?

The study was stopped early (reason given: terminated). Results are not available in the source record.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Relapse free survival (time frame: up to 24 months). 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 NCT05071482.

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 1 May 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in