NCT07463651 MRD-guided Maintenance Post-HCT: Gilteritini vs Sorafenib
| NCT ID | NCT07463651 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | The First Affiliated Hospital of Soochow University |
| Condition | Acute Myeloid Leukemia (AML) |
| Study Type | INTERVENTIONAL |
| Enrollment | 594 participants |
| Start Date | 2026-05-01 |
| Primary Completion | 2028-05-31 |
Trial Parameters
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Brief Summary
The study population consisted of FLT3-ITD-mutated AML patients who were FLT3-ITD-positive before allogeneic hematopoietic stem cell transplantation. This open-label, randomized, controlled trial enrolled participants and randomly assigned them in a 1:1 ratio to either the experimental group or the control group. The experimental group received maintenance therapy with gilteritinib, while the control group received maintenance therapy with sorafenib, with 297 cases in each group, totaling 594 enrolled subjects. All patients' minimal residual disease (MRD) testing was sent to the designated central laboratory and uniformly performed using the PCR-NGS method to ensure consistency and comparability of the test results. Study Visits: This study includes a screening period (within 30 days prior to HCT) and a 2-year treatment phase, with efficacy and safety follow-up until death, withdrawal of informed consent, or 2 years after the first administration of treatment, whichever occurs first.
Eligibility Criteria
Inclusion Criteria: * Informed consent and willingness to participate in this clinical study; * Gender is not limited, age range is 14-70 years old (including threshold); * ECOG score 0-2 points; * Diagnosed with AML through bone marrow morphology, immunology, cytogenetics, and molecular biology (MICM) typing, and confirmed to have FLT3-ITD mutation; * Successfully accepted allo HSCT, with no restrictions on the pre-treatment protocol, allowing any donor source \[fully matched cell, unrelated donor (URD), incompatible unrelated donor, haploidentical relative donor or umbilical cord blood\], allowing any graft source \[umbilical cord blood, bone marrow (BM), peripheral blood (PB)\]; ⑥ Patients with complete morphological remission (CR) prior to allo HSCT, and FLT3-ITD MRD positivity detected by PCR-NGS within 30 days prior to allo HSCT (defined as FLT3-ITD transcript level ≥ 10 - 6); ⑦ After transplantation: hematopoietic function implantation (ANC ≥ 500/μ L, platelet count ≥ 20000/μ L
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