NCT07551037Toboroz1. fázis
Efficacy and Safety of Autologous Peptide-induced Active Immunity in AML Maintenance Therapy
A Randomized, Controlled, Prospective Study on the Efficacy and Safety of Active Immunity Induced by Autologous Peptides for Maintenance Therapy in Acute Myeloid Leukemia (AML)
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. máj. 1.
Rövid összefoglaló (regiszter, angolul)
Acute myeloid leukemia (AML) is the most common acute leukemia in adults. While approximately 70% of patients achieve complete remission (CR) with induction chemotherapy, traditional consolidation therapy (predominantly high-dose cytarabine) has a persistently high recurrence rate - nearly 30% at 1 year for low-risk groups and 80% for high-risk groups - with a long-term survival rate <40%. Allogeneic hematopoietic stem cell transplantation (allo-HSCT) improves survival but is limited by donor matching and patient tolerance, resulting in a transplantation rate <20%. Clinically, there is an urgent need for a well-tolerated, low hepatotoxic/nephrotoxic maintenance regimen effective for preventing recurrence. Tumor immunotherapy is a major breakthrough, and neoantigen-based personalized vaccines are a key anti-recurrence direction due to their strong tumor specificity and ability to induce long-term immune memory. However, existing neoantigen vaccines rely on NGS sequencing and bioinformatics for epitope screening, suffering from long development cycles, high costs, proneness to missing cancer-causing mutations, and poor clinical feasibility, hindering widespread use. This study adopts a patented Sino-US innovative technology: in vitro induction of patients' own AML cells to obtain a complete set of tumor antigen peptides for personalized vaccine preparation, circumventing traditional bottlenecks to achieve "full antigen coverage" personalized active immunity. This study has significant clinical and scientific value: (1) It is the first application of this patented technology in AML maintenance therapy, filling domestic and international research gaps and providing a novel treatment option; (2) Using a randomized controlled design, it compares the efficacy of immunotherapy administered during vs. after consolidation chemotherapy to identify the optimal treatment mode; (3) It screens reliable anti-leukemia immunity monitoring methods and time points, offering evidence-based support for efficacy evaluation and prognostic prediction; (4) It verifies the treatment's safety, laying a foundation for developing low-toxic, high-efficacy AML maintenance regimens, ultimately improving patients' long-term survival and advancing precision immunotherapy for AML.
- Állapot (regiszter)
- Toboroz
- Fázis (regiszter)
- 1. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 90 (tervezett)
- Első benyújtás
- 2026. ápr. 20.
- Kezdés
- 2024. szept. 1.
- Elsődleges befejezés
- 2026. szept. 1.
- Fő szponzor
- Fujian Medical University Union Hospital
- Betegségek
- Akut mieloid leukémia (AML)
- NCT-szám
- NCT07551037
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 1. fázis
- Tervezett résztvevők: 90
- 2024. szept. 1. és az elsődleges befejezés (2026. szept. 1.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
Ki nem vehet részt
Szó szerint a(z) ClinicalTrials.gov forrásból, témák szerint csoportosítva. Hogy ki vehet részt, azt csak a vizsgálat csapata dönti el.
Korábbi kezelés
- Patients who still require hormonal maintenance therapy after achieving remission.
- Having participated in other clinical trials within 1 month prior to screening.
- Occurrence of severe chemotherapy-induced toxic reactions, or chemotherapy delay of more than 4 weeks due to adverse reactions.
Más betegség
- Patients with a concomitant history of other malignant tumors or a history of uncontrolled malignant tumors.
- Complicated with uncontrolled cerebrovascular diseases, coagulation disorders, connective tissue diseases and other similar conditions.
- Having other uncontrolled diseases that the investigator deems unfit for enrollment.
- Patients with psychiatric disorders or those known/suspected to be unable to fully comply with the study protocol.
- HIV-infected individuals.
- Other conditions that the investigator deems may prevent the subject from completing the study or pose a significant safety risk to the subject.
- Withdrawal Criteria：
- Disease progression or initiation of other anti-leukemia therapy.
Laborértékek
- Cardiac toxicity: Left Ventricular Ejection Fraction (LVEF) ≤ 50% or a decrease of > 10%; or QTc prolongation meeting the following criteria: ① QTc > 500 ms; ② QTc > 530 ms in patients with bundle branch block.
- Hepatic toxicity: Persistent elevation of alanine transaminase (ALT) and/or aspartate transaminase (AST) to more than 2 times the upper limit of normal (ULN), with no response to hepatoprotective treatment.
Egyéb
- Pregnant or lactating women.
- Judged by the investigator to be in the best interest of the subject.
- The subject requests to withdraw from the study for any reason at any time.
- Lost to follow-up.
- Death.
Kiket keres a vizsgálat
- Newly diagnosed with acute myeloid leukemia (AML) in accordance with the 2018 WHO Classification and Diagnostic Criteria for Acute Leukemias; received 1-2 courses of conventional chemotherapy, achieved remission, and are undergoing routine consolidation therapy.
- Aged 18 to 70 years.
- Receiving a maintenance therapy regimen without hormonal agents.
- Leukocyte and lymphocyte counts have basically returned to the normal range.
- Patients judged by the investigator to have an expected survival of at least 12 months after achieving remission.
- Patients who voluntarily participate in this study and sign the informed consent form.
Életkor a regiszterben: 18 év – 70 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Fujian Medical University Union Hospital | Fuzhou | Kína | Toboroz |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.