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Набор скоро начнётся NCT07717164

PRAISE-IR Versus CIBMTR Controls

— Наблюдательное ALL (Acute B-Lymphoblastic Leukemia) AML (Acute Myeloid Leukemia) MDS (Myelodysplastic Syndrome)

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: ALL (Acute B-Lymphoblastic Leukemia), AML (Acute Myeloid Leukemia), MDS (Myelodysplastic Syndrome). Базовые параметры: 1 год — 66 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
США
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

Comparison of the PRAISE -IR ("Phase 2 Study of Personalized r-ATG (Rabbit Anti-thymocyte Globulin) Dosing to Improve Survival Through Enhanced Immune Reconstitution in Pediatric and Adult Patients Undergoing Ex-vivo CD34-Selected Allogeneic-HCT (Hematopoietic Cell Transplantation) ", NCT04872595) Study Population With CIBMTR Controls

Обзор

The rationale to conduct this RWE study is to provide data to support the safety of CD34 selected grafts versus T replete PBSC transplants to address concerns about increased TRM in CD34 selected graft recipients.

Подробное описание

Comparison of the PRAISE -IR ("Phase 2 Study of Personalized r-ATG Dosing to Improve Survival Through Enhanced Immune Reconstitution in Pediatric and Adult Patients Undergoing Ex-vivo CD34-Selected Allogeneic-HCT", NCT04872595) study population with CIBMTR controls

Первичные конечные точки

  • Comparison of OS between PRAISE-IR study participants (Arm A) with CIBMTR control participants who have received a CD34 selected graft and standard dose ATG (Arm B) with the goal of demonstrating superiority of Arm A. [Срок оценки: two years]
Вторичные конечные точки (7)
  • Acute GVHD, grades II-IV [Срок оценки: two years]
  • Chronic GVHD [Срок оценки: two years]
  • Hematologic recovery (time to neutrophil engraftment and time to platelet engraftment) [Срок оценки: two years]
  • Rate of primary graft failure [Срок оценки: two years]
  • Non-relapse mortality [Срок оценки: two years]
  • Relapse [Срок оценки: two years]
  • Relapse-free survival [Срок оценки: two years]

Критерии участия

Критерии включения

Arm A: Model-based ATG dosing CD34-selection (PRAISE-IR population)

  • Patients who participated in the PRAISE-IR single center phase II study
  • Patient age at transplant: ≥ 1 year and < 66 years
  • HLA 8/8 MRD or MUD
  • Conditioning intensity: myeloablative
  • Conditioning regimens: Model-based ATG with TBI/Thiotepa/Cyclophospamide (TBI/Thio/Cy) or Busulfan/Melphalan/Fludarabine (Bu/Mel/Flu).
  • Morphologic complete remission at the time of alloHCT Arm B: Standard ATG dosing CD34-selection (CIBMTR population)
  • First AlloHCT in the US between 2021-2023
  • Patient age at transplant: ≥ 1 year and < 66 years
  • Disease: Patients with AML, MDS, and ALL
  • HLA 8/8 MRD or MUD
  • Peripheral blood stem cell allograft
  • Conditioning intensity: myeloablative conditioning
  • Conditioning regimens: standard dose ATG (2.5 mg/kg/day given on Day -4 and Day -3)
  • GVHD prophylaxis: ex vivo CD34 selection
  • Morphologic complete remission at the time of alloHCT Arm B\*:Standard ATG dosing CD34-selection (BMT CTN 1301 population)
  • Patients in BMT CTN 1301, who received the CD34-selected graft
  • Patient age at transplant: ≥ 1 year and < 66 years
  • Disease:Patients with AML, MDS, and ALL
  • HLA 8/8 MRD or MUD
  • Peripheral blood stem cell allograft
  • Conditioning intensity: myeloablative conditioning
  • Conditoning regmens: TBI/Thiotepa/Cyclophospamide (TBI/Thio/Cy) or Busulfan/Melphalan/Fludarabine (Bu/Mel/Flu) and standard dose ATG (2.5 mg/kg/day given on Day -4 and Day -3)
  • GVHD prophylaxis: ex vivo CD34 selection
  • Morphologic complete remission at the time of alloHCT Arm C: Control CIBMTR population
  • First AlloHCT in the US between 2021-2023
  • Patient age at transplant: ≥ 1 year and < 66 years
  • Disease:Patients with AML, MDS, and ALL
  • HLA 8/8 MRD or MUD
  • Peripheral blood stem cell
  • Conditioning intensity: myeloablative conditioning
  • Conditioning regimens: Busulfan/Cyclophosphamide (Bu/Cy), Busulfan/Fludaranbine (Bu/Flu), Cyclophosphamide/TBI (Cy/TBI), TBI/Etopsoside
  • GVHD prophyalxis: / CNI or PTCy-based
  • CNI-based: CNI (tacrolimus or ciclosporin) plus MTX
  • PTCy-based: Cyclophosphamide on day +3 and +4 (50 mg/kg/d) combined with CNI and mycophenolate mofetil (MMF)

Критерии исключения

Patients will be entered into this trial only if they meet none of the following criteria:

Arm A: Model-based ATG dosing CD34-selection (PRAISE-IR population)

  • HLA <8/8 MRD or MUD Arm B: Standard ATG dosing CD34-selection (CIBMTR population)
  • Patients who participated in the PRAISE-IR study
  • Patients who did not sign consent for research
  • Patient transplanted at a center that does not meet CIBMTR data quality standards
  • Use of CNI-(Tac/MTX) or PTCy-based GVHD prophylaxis Arm B\*:Standard ATG dosing CD34-selection (BMT CTN 1301 population)
  • Patients who did not sign consent for research
  • Patient transplanted at a center that does not meet CIBMTR data quality standards
  • Use of CNI- or PTCy-based GVHD prophylaxis Arm C: Control CIBMTR population
  • Patients who did not sign consent for research
  • Patient transplanted at a center that does not meet CIBMTR data quality standards
  • Use of ATG and/or alemtuzumab
  • Patients who received PTCy with sirolimus (and not a CNI)
  • Use of ex vivo CD34 selection

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Другое

Центры проведения

США · 1 центр
  • Memorial Sloan Kettering Cancer center — New York

Идентификаторы

NCT: NCT07717164 · PROJXXXX

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗