Меню
Идёт набор NCT07359859

A Study of Ruxolitinib for Preventing Graft-Versus-Host Disease in People With a Hematologic Malignancy Who Will Receive a Stem Cell Transplant

Фаза II С лечением Hematologic Malignancies

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
В протоколе указаны: Cyclophosphamide, Cyclophosphamide, Mycophenolate Mofetil, Ruxolitinib.
Кому может быть актуально
Состояния в реестре: Hematologic Malignancies. Базовые параметры: от 18 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 →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Randomized Pilot Study of Ruxolitinib for Switch-Maintenance Prophylaxis of Graft-versus-Host Disease in Allogeneic Hematopoietic Cell Transplantation After Intermediate-Dose Post-Transplant Cyclophosphamide (Rux Switch-Maintenance in Intermediate PTCY: RuSMa-PTCY) in Comparison to Full-Dose PTCY

Обзор

The researchers are doing this study to compare 2 different GVHD prevention (prophylaxis) approaches. The researchers will see which approach is good or more effective at preventing chronic GVHD until 1 year after allogeneic hematopoietic stem cell transplantation (allo-HCT).

Вмешательства

  • Препарат Cyclophosphamide
    An intermediate dose (medium dose) of Post-transplant Cyclophosphamide
  • Препарат Cyclophosphamide
    A full dose of Post-transplant Cyclophosphamide
  • Препарат Mycophenolate Mofetil
    Day +5 to +35
  • Препарат Ruxolitinib
    twice a day
  • Препарат Tacrolimus
    Day +5, taper per SoC
  • Препарат Tacrolimus
    Day +5, taper initiation within 2 weeks of starting Ruxolitinib

Первичные конечные точки

  • assess cGVHD-free survival [Срок оценки: 1 year post-HCT]
Вторичные конечные точки (1)
  • incidence of grade 2-4 infections. [Срок оценки: 1 year]

Критерии участия

Критерии включения

  • Patients ≥18- years-old at time of consent
  • Diagnosis: hematologic malignancy in morphologic remission (blasts <5%, no evidence of extramedullary disease in AML or MDS). Patients with CR with incomplete count recovery (CRp or CRi) or minimal residual disease are allowed. Patients with lymphoma must have a complete or partial response
  • Donor: related or unrelated 7-8/8 HLA-matched or related haploidentical
  • Karnofsky score ≥ 70%
  • Female subjects of childbearing potential (<50 years old) have a negative serum or urine pregnancy test. Females of childbearing potential are defined as females without prior hysterectomy or who have had any evidence of menses in the past 12 months.

°Sexually active females of childbearing potential enrolled in the study must agree to consistently use two forms of accepted methods of contraception during the course of the study and for 3 months after their last dose of the study drug. Effective birth control includes: \*Intrauterine device (IUD) plus one barrier method \*Stable doses of hormonal contraception for at least 3 months (e.g., oral, injectable, implant, transdermal) plus one barrier method \*2 barrier methods. Effective barrier methods are male or female condoms, diaphragms, and spermicides (creams or gel that contain a chemical to kill sperm); or \* A vasectomized partner.

  • For male subjects who are sexually active and who are partners of females of childbearing potential: Agreement to use two forms of contraception as per above and to not donate sperm during the treatment period and for at least 3 months after the last dose of study drug

Критерии исключения

  • Recipient of CD34+ selected or engineered stem cell graft
  • Treatment with in vivo T cell depletion (e.g. anti-thymocyte globulin)
  • Patients with an active secondary malignancy or prior malignancy requiring systemic therapy within the past 5 years. Exceptions include adequately treated localized non-melanoma skin cancer (basal cell carcinoma and squamous cell carcinoma), as well as localized prostate cancer considered low risk and stable under treatment or surveillance.
  • Severely impaired renal function defined by serum creatinine > 2mg/dL, renal dialysis requirement.
  • Use of investigational agent within 14 days pre-HCT
  • Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within the past 6 months
  • Uncontrolled psychiatric illness
  • Female patient who is pregnant or breastfeeding
  • Known allergy or sensitivity to ruxolitinib

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

США · 7 центров
  • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) — Basking Ridge
  • Memorial Sloan Kettering Monmouth (Limited Protocol Activities) — Middletown
  • Memorial Sloan Kettering Bergen (Limited Protocol Activities) — Montvale
  • Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities) — Commack
  • Memorial Sloan Kettering Westchester (Limited Protocol Activities) — Harrison
  • Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York
  • Memorial Sloan Kettering Nassau (Limited Protocol Activites) — Rockville Centre

Идентификаторы

NCT: NCT07359859 · 25-212

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗