Venetoclax-containing Therapy Combined With Microtransplant for Newly Diagnosed AML

Официальное название

Phase 2 Study of Venetoclax-containing Therapy in Combination With HLA-mismatched Mobilized Peripheral Blood Mononuclear Cell Infusion for Newly Diagnosed Acute Myeloid Leukemia

Обзор

The purpose of this study is to evaluate whether HLA-mismatched donor G-CSF mobilized peripheral blood mononuclear cell (GPBMC) infusion with venetoclax-containing regimens (microtransplant, MST) could improve survival in adult patients with newly diagnosed acute myeloid leukemia (AML).

Вмешательства

• Препарат Venetoclax
  Given PO
• Препарат Azacitidine (AZA)
  Given SC
• Препарат Daunorubicin
  Given IV
• Препарат Idarubicin（IDA）
  Given IV
• Препарат Cytarabine (Ara-C)
  Given IV
• Биопрепарат GPBMC infusion
  HLA-mismatched donor GPBMC infusion

Первичные конечные точки

• Overall survival (OS) [Срок оценки: Measured up to 4 years after the last participant is enrolled]
• Event-free Survival (EFS) [Срок оценки: Measured up to 4 years after the last participant is enrolled]

Вторичные конечные точки (3)

• Complete remission (CR) and complete remission with incomplete marrow recovery (CRi) [Срок оценки: Measured up to 2 years after the last participant is enrolled]
• Partial remission (PR) [Срок оценки: Measured up to 2 years after the last participant is enrolled]
• Non-relapse Mortality (NRM) [Срок оценки: Measured up to 4 years after the last participant is enrolled]

Критерии участия

Критерии включения

• Age >=18 years, male or female, non-limited by race or ethnicity.
• No prior anti-acute leukemia treatment (including hypomethylators for leukemia or MDS) with the exception that prior hydroxyurea and/or leukapheresis are permitted.
• Confirmed acute myeloid leukemia in accordance with WHO criteria with a WBC count < 25 × 109/L.
• Adequate hepatic function including alanine transaminase (ALT) and aspartate aminotransferase (AST )<= 3 × upper limit of normal(ULN), and total bilirubin <= 1.5 × ULN.
• Adequate renal function including serum creatinine <= 2 × ULN or CrCl>= 40mL/min.
• LVEF measured by echocardiogram is within the normal range (LVEF > 50%).
• The subject must have one donor who is >= 18 years old and HLA matched at 0-7/10 loci (i.e., at least 3 HLA loci must be mismatched). In addition, the donor voluntarily donates hematopoietic stem cells and signs the consent form.
• Each subject (or his/her legal representatives) must sign the Informed Consent Form (ICF), indicating that he/she understands the purpose and procedures of research, and is willing to participate in research.
• Donor inclusion criteria: The donor meets the institution's criteria for related peripheral blood hematopoietic stem cell donors. The donor must be able to tolerate the cell separation and collection process, and sign the Informed Consent Form.

Критерии исключения

• Acute promyelocytic leukemia, myeloid sarcoma, chronic myeloid leukemia accelerated phase and blast crisis.
• Uncontrolled infection or hemorrhage.
• Cardiovascular disease with clinical significance, such as uncontrolled or highly symptomatic cardiac arrhythmias, congestive heart failure, or myocardial infarction within 6 months prior to screening, or New York Heart Association (NYHA) function class 3 (moderate) or class 4 (severe) heart disease.
• Uncontrolled autoimmune disease or requiring immunosuppression treatment.
• History of severe blood infusion reaction.
• Nursing women, women of childbearing potential with positive urine pregnancy test, or women of childbearing potential who are not willing to maintain adequate contraception.
• Psychiatric disorder or cognitive impairment that in the researcher's judgment would make the subject not likely to adhere to the protocol requirements.
• Any major surgery within 4 weeks before enrollment.
• Life-threatening illness other than AML or uncontrolled intercurrent illness.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Department of Hematology, the Fifth Medical Center of Chinese PLA General Hospital — Пекин

Идентификаторы

NCT: NCT07078591 · VEN-MST for AML

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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