A Study to Evaluate Vimseltinib in Adults With Active Chronic Graft-Versus-Host Disease (cGVHD)

Официальное название

A Phase 2, Open-label, Multicenter Study to Evaluate the Safety, Tolerability, PK, and Efficacy of Vimseltinib in Adults With Active Chronic GVHD After Failure of Prior Systemic Therapy

Обзор

The purpose of this study is to determine if vimseltinib is safe, tolerable and works effectively to treat adults with active moderate to severe cGVHD. Participants will be treated with vimseltinib in 28-day treatment cycles for approximately 2 years.

Вмешательства

• Препарат Vimseltinib
  Administered orally

Первичные конечные точки

• Number of Participants with Dose-Limiting Toxicities (DLTs) [Срок оценки: Cycle 1 (28 Days)]
• Number of Participants with Adverse Event(s) (AEs) and Serious Adverse Event(s) (SAEs) [Срок оценки: Baseline to Study Completion (Estimated up to 24 months)]

Вторичные конечные точки (5)

• Objective Response Rate (ORR) [Срок оценки: Baseline up to Cycle 7 Day 1 (Cycle = 28 days)]
• Duration of Response (DOR) [Срок оценки: First CR or PR until PD or Death due to Any Cause (Estimated up to 24 months)]
• Organ-Specific Response [Срок оценки: Baseline up to Cycle 7 Day 1 (Cycle = 28 days)]
• Failure-Free Survival (FFS) [Срок оценки: Baseline to, whichever occurs first of, PD, Addition of Systemic Immune Suppressive Therapy, or Death due to Any Cause (Estimated up to 24 months)]
• Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax) [Срок оценки: Estimated up to 24 months]

Критерии участия

Критерии включения

• Must be allogeneic hematopoietic stem cell transplant (HSCT) recipients with moderate to severe cGVHD requiring systemic immune suppression.

a. May have persistent active acute GVHD (aGVHD) and chronic GVHD (cGVHD) manifestations (overlap syndrome).

• Participants with active cGVHD who have received and failed at least 2 prior lines of systemic therapy.
• Stable dose of systemic corticosteroids is permitted but not required. If being taken, participants should be on a stable dose of corticosteroids for at least 2 weeks prior to starting study drug treatment.
• Adequate organ and bone marrow functions.
• Participants of reproductive potential agree to follow the contraception requirements.
• Karnofsky Performance Scale (KPS) of ≥60.

Критерии исключения

• Has aGVHD without manifestations of cGVHD.
• Prior use of colony-stimulating factor 1 receptor (CSF1R) inhibitor for cGVHD.
• History or other evidence of severe illness, uncontrolled infection, or any other conditions that would make the participant unsuitable for the study. All wounds must be healed and free of infection or dehiscence.
• History of malignancy except for:

• Underlying malignancy for which the transplant was performed
• Malignancy treated with curative intent and with no evidence of active disease present for more than 3 years prior to enrollment and felt to be at low risk for recurrence.
• Malabsorption syndrome or other illness that could affect oral absorption.

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

США · 26 центров

• City of Hope National Medical Center — Duarte
• Ronald Regan UCLA Medical Center — Los Angeles
• University of California Irvine Health — Orange
• AdventHealth Orlando — Orlando
• Moffitt Cancer Center — Tampa
• Emory University Winship Cancer Institute — Atlanta
• University of Illinois Medical Center - Hematology & Oncology — Chicago
• University of Kansas Cancer Center-Westwood — Westwood
• … и ещё 18 центров

Идентификаторы

NCT: NCT06619561 · DCC-3014-02-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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