Идёт набор NCT07495631

Pediatric-Inspired Regimen Combined With Venetoclax and Immunotherapy for Adult Ph-Negative Acute Lymphoblastic Leukemia

Без фазы С лечением Acute Lymphoblastic Leukemia, Adult

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: VDCLP+V, 2VIP, Consolidation Therapy, Maintenance Therapy.
Кому может быть актуально: Состояния в реестре: Acute Lymphoblastic Leukemia, Adult. Базовые параметры: 14 лет — 60 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Китай
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Prospective Cohort Study of a Pediatric-Inspired Chemotherapy Regimen Combined With Venetoclax and Immunotherapy for the Treatment of Adult Ph-Negative Acute Lymphoblastic Leukemia

Обзор

This is a prospective, open-label, non-randomized cohort study evaluating the efficacy and safety of a pediatric-inspired chemotherapy regimen (IH-2014 based) combined with venetoclax and immunotherapy in adult patients with newly diagnosed Ph-negative Acute Lymphoblastic Leukemia (ALL). Patients aged ≥14years,≤60 years will be enrolled. Treatment includes induction, consolidation, early intensification, delayed intensification, and maintenance phases. The use and number of cycles of immunotherapy will be based on patient preference. The primary endpoint is Event-Free Survival (EFS) and MRD-negative CR rates after induction therapy(by flow cytometry and NGS). Secondary endpoints include Complete Remission (CR) rate, MRD-negative CR rates at 12 weeks (by flow cytometry and NGS), Overall Survival (OS), Relapse-Free Survival (RFS), and cumulative relapse rate.

Подробное описание

Adult Ph-negative ALL has inferior outcomes compared to childhood ALL. Pediatric-inspired regimens have improved survival in adolescent and young adult (AYA) patients. Venetoclax, a BCL-2 inhibitor, has shown preclinical sensitivity in Ph-negative ALL. Our center's previous IH-2022 regimen (a pediatric-inspired regimen combined with venetoclax protocol) showed promising efficacy and tolerability in adult patients.Immunotherapy is effective in ALL. This study aims to integrate immunotherapy into the pediatric-inspired backbone to optimize the regimen and improve survival outcomes.

Вмешательства

Препарат VDCLP+V
Vincristine, daunorubicin, cyclophosphamide, pegaspargase, prednisone, and venetoclax.
Препарат 2VIP
Inotuzumab ozogamicin, venetoclax, vincristine, and prednisone.
Препарат Consolidation Therapy
Includes vincristine, daunorubicin, cyclophosphamide, pegaspargase, prednisone, dexamethasone, cytarabine, 6-mercaptopurine, and high-dose methotrexate.
Препарат Maintenance Therapy
Monthly MM regimen (6-mercaptopurine and methotrexate) and every 3 months VP (vincristine and prednisone) plus venetoclax.
Препарат Blinatumomab
Optional; 1 to 4 cycles (28 days each) based on patient choice, starting post-induction, alternating with chemotherapy cycles.
Препарат Venetoclax
Oral targeted therapy administered during induction, consolidation, and maintenance phases as per protocol
Процедура CNS Prophylaxis
Intrathecal injection (methotrexate, cytarabine, dexamethasone) for a total of at least 15 sessions. Prophylactic cranial irradiation (18 Gy) is an alternative for patients unable or unwilling to receive intrathecal injections.
Процедура CAR-T Cell Therapy
Preconditioning regimen with fludarabine and cyclophosphamide (FC) administered after the third course (second consolidation) for patients receiving CAR-T.
Процедура Hematopoietic Stem Cell Transplantation (HSCT)
Allogeneic or autologous HSCT considered for high-risk patients or those with positive MRD after induction in CR1, provided a suitable donor is available.

Первичные конечные точки

Event-Free Survival [Срок оценки: up to 5 years]
MRD-negative CR rate by flow cytometry after induction regimen [Срок оценки: up to 6 weeks]

Вторичные конечные точки (6)

Complete Remission Rate [Срок оценки: up to 1 year]
MRD-negative CR rate by flow cytometry at 12 weeks [Срок оценки: up to 12 weeks]
MRD-negative CR rate by NGS at 12 weeks [Срок оценки: up to 12 weeks]
Overall Survival (OS) [Срок оценки: Up to 5 years]
Relapse-Free Survival (RFS) [Срок оценки: Up to 5 years]
Cumulative Incidence of Relapse [Срок оценки: Up to 5 years]

Критерии участия

Критерии включения

Newly diagnosed, previously untreated (except prednisone/hydroxyurea) Ph-negative ALL
Age ≥14 years, ≤60 years
ECOG performance status ≤2
Adequate organ function (liver, kidney, cardiac)
For patients of childbearing potential: use of effective contraception
Willing and able to provide informed consent