VA Combined With PD-1 Inhibitor for the Treatment of Relapsed and Refractory AML and High-risk MDS

Официальное название

A Study of VA Combined With PD-1 Inhibitor in the Treatment of Relapsed and Refractory AML and High-risk MDS

Обзор

The efficiency and safety of PD-1 inhibitor in combination with venetoclax and hypomethylation agent in relapsed/refractory acute myeloid leukemia or high-risk myelodysplastic syndrome remain uncertain. In this study, the investigators aimed to assess safety and response to a new PD-1 inhibitor-based triple-drug combination regimen (venetoclax + hypomethylation agent + PD-1 inhibitor) in relapsed/refractory acute myeloid leukemia and high-risk myelodysplastic syndrome patients, or who had positive minimal residual disease.

Вмешательства

• Препарат PD-1 inhibitor, Venetoclax, Decitabine, Azacytidine
  For AML patients: PD-1 inhibitor was given at a dose of 200mg on day 21 of the treatment. Venetoclax was given at a dose of 400 mg/day for 28 days per cycle. Decitabine was given at a dose of 20 mg/m2/day for 5 days or azacytidine was given at a dose of 75 mg/m2/day for 7 days at the discretion of the treating physician. For MDS patients: PD-1 inhibitor was given at a dose of 200mg on day 21 of the treatment. Venetoclax was given at a dose of 400 mg/day for 14 days per cycle. Decitabine was giv

Первичные конечные точки

• Complete remission rate [Срок оценки: At the end of Cycle 2 (each cycle is 28 days)]
• Complete minimal residual disease (MRD) Response Rate [Срок оценки: At the end of Cycle 2 (each cycle is 28 days)]
• MRD Response Rate [Срок оценки: At the end of Cycle 2 (each cycle is 28 days)]

Вторичные конечные точки (4)

• Relapse-Free Survival [Срок оценки: 24 months]
• Overall Survival [Срок оценки: 24 months]
• Duration of response [Срок оценки: 24 months]
• Adverse events [Срок оценки: start of treatment to 2 weeks after end of treatment]

Критерии участия

Критерии включения

• Patients diagnosed with relapsed and refractory acute myeloid leukemia (AML) and patients diagnosed with myelodysplastic syndrome (MDS) who require chemotherapy treatment.
• Patients who did not respond or had disease recurrence after 1 course of induction chemotherapy or had positive immune residues after induction chemotherapy or positive molecular residues (if any) after induction chemotherapy.
• Voluntarily participate in clinical research and sign an informed consent form and be willing to follow and be able to complete all experimental procedures.
• The toxic and side effects caused by the last treatment should be recovered.
• Eastern Cooperative Oncology Group score of 0 to 3 points.
• The organ function is intact.

• Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤2×ULN (Upper Limit of Normal).
• Creatinine≤2×ULN.
• Bilirubin≤2×ULN.
• Karnofsky≥70.
• The expected survival period is at least 12 weeks.
• Non-pregnant, non-breastfeeding women.

Критерии исключения

• Suffering from other untreated or unrelieved malignant tumors within 2 years.
• Major surgery, radiotherapy, chemotherapy, biological therapy, immunotherapy, and experimental therapy were performed within 2 weeks of the first medication.
• Suffering from any other known serious and/or uncontrolled disease (eg, uncontrolled diabetes; cardiovascular disease, including congestive heart failure New York Heart Association \[NYHA\] Class III or IV, 6 months patients with myocardial infarction and poorly controlled blood pressure); chronic renal failure; or active uncontrolled infection); the investigators considered unsuitable for this clinical trial.
• Patients who are unwilling or unable to comply with the protocol.
• Currently being treated with other systemic anti-tumor or anti-tumor research drugs.
• Women who are pregnant or breastfeeding.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Xiao-ning Gao — Пекин

Идентификаторы

NCT: NCT06536959 · VA-PD1-MN

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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