Motixafortide for MRD Sensitization in AML

Официальное название

A Pilot Clinical Trial of Motixafortide for Measurable Residual Disease (MRD) Sensitization in Acute Myeloid Leukemia (AML)

Обзор

This is a pilot phase I study evaluating the effect of motixafortide on determination of measurable residual disease (MRD) level in patients with acute myeloid leukemia (AML) who have completed induction treatment. Consenting and eligible patients will undergo standard of care (SOC) bone marrow and peripheral blood assessments with SOC MRD assays, followed by a single injection of motixafortide. Ten to 14 hours after injection, the patient will undergo peripheral blood collection for the same applicable MRD tests

Вмешательства

• Препарат Motixafortide
  Motixafortide is a CXCR4 inhibitor for the mobilization of hematopoietic stem progenitor cells (HSPCs) in patients undergoing autologous stem cell transplantation. It is provided as a single subcutaneous injection.

Первичные конечные точки

• Efficacy of motixafortide on measurable residual disease (MRD) levels [Срок оценки: Day 1 before motixafortide and Day 2 (estimated total time is 2 days)]

Вторичные конечные точки (7)

• Proportion of patients changing from negative to positive MRD levels [Срок оценки: Day 1 before motixafortide and Day 2 (estimated total time is 2 days)]
• Percentage change in variant allele frequency (VAF) levels by next-generation sequencing (NGS) using error-corrected sequencing (MRD-Seq) [Срок оценки: Day 1 before motixafortide and Day 2 (estimated total time is 2 days)]
• Percentage change in VAF levels by NGS using MRD-Seq between bone marrow and peripheral blood assessments [Срок оценки: Day 1 before motixafortide and Day 2 (estimated total time is 2 days)]
• Percentage change in detectable transcript levels by polymerase chain reaction (PCR) [Срок оценки: Day 1 before motixafortide and Day 2 (estimated total time is 2 days)]
• Relapse-free survival (RFS) [Срок оценки: From Day 1 through completion of follow-up (estimated total time is 18 months)]
• Time to next line of therapy [Срок оценки: From Day 1 through completion of follow-up (estimated total time is 18 months)]
• Overall survival (OS) [Срок оценки: From Day 1 through completion of follow-up (estimated total time is 18 months)]

Критерии участия

Критерии включения

• Diagnosed with acute myeloid leukemia (AML), excluding APL, treated with 1-2 cycles of front-line chemotherapy.
• Achieved CBC parameters compatible with complete remission as defined by ELN 2022.
• Planning to undergo a standard of care blood draw and bone marrow assessment with SOC MRD assays, including morphology, flow cytometry for MRD, NGS panels for MRD, and PCR tests for MRD as applicable.
• At least 18 years of age.
• ECOG performance status ≤ 2
• Life expectancy > 3 months.
• Adequate organ function as defined below:

• Total bilirubin ≤ 2.0 x IULN
• AST(SGOT)/ALT(SGPT) ≤ 5.0 x IULN
• Creatinine clearance > 30 mL/min by Cockcroft-Gault
• Ability to understand and willingness to sign an IRB approved written informed consent document.

Критерии исключения

• Evidence of more than 5% blasts in in the peripheral blood by manual differential within 5 days prior to study enrollment.
• Prior history of allogeneic stem cell transplant.
• Prior or concurrent malignancy whose natural history has the potential to interfere with the safety or efficacy assessment of the investigational regimen. Patients with prior or concurrent malignancy that does NOT meet that definition are eligible for this trial
• Currently receiving any other investigational agents.
• A history of allergic reactions attributed to compounds of similar chemical or biologic composition to motixafortide.
• Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia. Patients with a known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Function Classification; to be eligible for this trial, patients should be a class 2B or better.
• Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry.
• HIV-infected if not on effective anti-retroviral therapy with undetectable viral load for 6 months. Patients with HIV who are receiving effective anti-retroviral therapy and have had an undetectable viral load for at least 6 months are eligible. HIV testing not required in the absence of known history of infection.
• Evidence of chronic hepatitis B virus (HBV) that is detectable on suppressive therapy. Patients with evidence of chronic HBV infection with undetectable HBV viral load on suppressive therapy are eligible. HBV testing not required in the absence of known history of infection.
• History of hepatitis C virus (HCV) infection that has not been cured or that has a detectable viral load. Patients with a history of HCV that has been treated and cured are eligible. Patients with HCV infection who are currently on treatment and have an undetectable HCV viral load are eligible. HCV testing not required in the absence of known history of infection.

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

Диагностика

Центры проведения

США · 1 центр

• Washington University School of Medicine — St Louis

Идентификаторы

NCT: NCT07392970 · 202603045

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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