NCT06561880 The Efficacy of Triple Regimen in Newly Diagnosed AML Patients With FLT3 Mutation
| NCT ID | NCT06561880 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China |
| Condition | FLT3 Gene Mutation |
| Study Type | INTERVENTIONAL |
| Enrollment | 66 participants |
| Start Date | 2024-10-08 |
| Primary Completion | 2026-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 66 participants in total. It began in 2024-10-08 with a primary completion date of 2026-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The FMS tyrosine kinase 3 (FLT3) gene mutation occurs in 30% of newly diagnosed AML patients, leading to a higher relapse rate and mortality rate. In the past, multi-drug combination chemotherapy regimens had limited efficacy in newly diagnosed AML patients with FLT3 mutations, especially in those with FLT3-ITD. However, the FLT3 inhibitors greatly improved the survival of AML patients with FLT3 mutations. Although several studies have focused on the effectiveness of FLT3 inhibitor combination therapy for FLT3-mutated AML, further studies are needed to determine the optimal regimen and dosage. A triple regimen consisting of Gilteritinib, Venetoclax, and Azacitidine had shown good efficacy in unfit newly diagnosed FLT3-mutated AML patients. This clinical trial aims to determine the optimal triple regimen and investigate its efficacy in newly diagnosed fit FLT3-mutated AML patients.
Eligibility Criteria
Inclusion Criteria: 1. MDS/AML patients WHO meet AML and ICC definitions according to WHO (2022) or ICC standards (10%-20% of bone marrow naive cells) and have FLT3-TKD or ITD mutations detected by PCR or second-generation sequencing. 2. Age ≥15 years old, male or female. 3. The physical status assessment (ECOG-PS) of the Eastern Oncology Collaboration group was 0-2 points. 4. Pass the requirements of the following laboratory tests (performed within 7 days before treatment) : 1\) Total bilirubin ≤ 1.5 times the upper limit of normal value (same age); 2) AST and ALT≤ 2.5 times the upper limit of normal value (same age); 3) Blood creatinine \< 2 times the upper limit of normal (same age); 4) Myocardial enzymes \< 2 times the upper limit of normal (same age); 5) Echocardiography (ECHO) was performed to determine the ejection fraction of the heart within the normal range. Exclusion Criteria: 1. Acute promyelocytic leukemia with PML-RARA fusion gene 2. Acute myeloid leukemia with RUNX1-RUNX1T1 or CBFB-MYH11 fusion gene 3. Acute myeloid leukemia with BCR-ABL fusion gene 4. Have treated patients (those who have previously received induction chemotherapy but can receive hydroxyurea down-cell therapy). 5. Concurrent malignant tumors of other organs (those requiring treatment). 6. Active heart disease, defined as one or more of the following: 1\) A history of uncontrolled or symptomatic angina; 2) Myocardial infarction less than 6 months after enrollment; 3) Have a history of arrhythmia requiring drug treatment or severe clinical symptoms; 4) Uncontrolled or symptomatic congestive heart failure (\> NYHA level 2); 5) The ejection fraction is lower than the lower limit of the normal range. 7. Serious infectious diseases (uncured tuberculosis, pulmonary aspergillosis). 8. Those who were not considered suitable for inclusion by the researchers.
Contact & Investigator
Hui Wei, doctor
PRINCIPAL INVESTIGATOR
Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Frequently Asked Questions
Who can join the NCT06561880 clinical trial?
This trial is open to participants of all sexes, aged 14 Years or older, studying FLT3 Gene Mutation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06561880 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06561880 currently recruiting?
Yes, NCT06561880 is actively recruiting participants. Contact the research team at weihui@ihcams.ac.cn for enrollment information.
Where is the NCT06561880 trial being conducted?
This trial is being conducted at Tianjin, China.
Who is sponsoring the NCT06561880 clinical trial?
NCT06561880 is sponsored by Institute of Hematology & Blood Diseases Hospital, China. The principal investigator is Hui Wei, doctor at Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College. The trial plans to enroll 66 participants.