M-2018-334 in Hematological Malignancies

Официальное название

A Single-center Pilot Study Using TCRα/β and CD45RA Depleted Stem Cell Grafts From Haploidentical Donors for Hematopoietic Cell Transplantation in Adults(HAPLO2022)

Обзор

This is a single-center, open-label, single-arm, pilot clinical study using TCRα/β and CD45RA depleted stem cell grafts from haploidentical donors for hematopoietic cell transplantation in 12 to 18 adult patients.

Вмешательства

• Устройство CliniMACS Prodigy® LP-TCRα/β-19-45RA (Trial Version)
  PBSC grafts from haploidentical donors depleted of TCRaβ+ cells and CD45RA+ cells using CliniMACS Prodigy® will be infused into patients intravenously (IV)

Первичные конечные точки

• Incidence of severe acute GVHD (aGVHD) till Day 100 [Срок оценки: 100 days after haploidentical hematopoietic cell transplantation]

Вторичные конечные точки (12)

• Performance of the CliniMACS Prodigy® LP-TCRα/β-19-45RA(Trial Version) [Срок оценки: Until Last Patient Last Visit(24 Months)]
• Incidence of acute GVHD (aGVHD) till six months post-transplantation [Срок оценки: 6 Months]
• Neutrophil Engraftment [Срок оценки: Day 7]
• Platelet Engraftment [Срок оценки: Day 0]
• Chronic GVHD [Срок оценки: 1 Year]
• Non-relapse mortality (NRM) [Срок оценки: Until Last patient last Visit(24 Months)]
• Infusion toxicity [Срок оценки: 15 minutes, 30 minutes, 2 hours, and 4 hours post infusion]
• Graft failure [Срок оценки: 30 Days]
• Overall survival (OS) [Срок оценки: Day 100 and through study completion, an average of 1 year post transplantation]
• Disease-free survival (DFS) [Срок оценки: Day 100 and through study completion, an average of 1 year post transplantation]
• GVHD/relapse-free survival (GRFS) [Срок оценки: GRFS will be assessed at Month 12 post transplantation]
• Immunosuppression-free survival (ISFS) [Срок оценки: Assessed at 1 year with a starting point at Day 45 post-transplantation]

Критерии участия

Критерии включения

• Patients, between 18 years to 75 years of age, with high-risk hematological malignancy requiring an allogeneic hematopoietic stem cell transplantation (AlloHCT), but do not have an HLA-matched donor available

Критерии исключения

• <3 months after preceding autologous transplantation or prior AlloHCT
• History of neurological impairment (active seizures, severe peripheral neuropathy, signs of leukoencephalopathy, active CNS infection)
• Active fungal infections with radiological and clinical progression
• Liver function abnormalities with bilirubin >2 mg/dL and elevation of transaminases higher than 400 U/L
• Chronic active viral hepatitis
• Cardiac dysfunction: adult patients ejection fraction <50% on echocardiography
• Patients with uncontrolled, >grade II hypertension (per Common Toxicity Criteria, CTC)
• Creatinine clearance <60 mL/min/1.73m2
• Respiratory failure necessitating supplemental oxygen
• HIV infection
• Positive anti-donor HLA antibody
• Treatment with checkpoint inhibitors in the period between 3 months prior to and 3 months after transplantation
• Female patients who are pregnant or breast feeding, or adults of reproductive potential not willing to use an effective method of birth control during study treatment and for at least 12 months thereafter. Note: Women of childbearing potential must have a negative serum pregnancy test at study entry
• Concurrent severe or uncontrolled medical disease (e.g., uncontrolled diabetes, myocardial infarction within 6 months prior to the study) which by assessment of the treating physician could compromise participation in the study
• Patients with a history of psychiatric illness or a condition which could interfere with their ability to understand the requirements of the study (this includes alcoholism/drug addiction).
• Patients unwilling or unable to comply with the protocol or unable to give informed consent
• Treatment with any investigational product within 4 weeks prior to study treatment

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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06225050 · M-2018-334

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗