Набор скоро начнётся NCT07358195

Addition of Venetoclax to Combined Hematopoietic Stem Cell and Kidney Transplantation

Ранняя фаза I С лечением Kidney Failure Chronic Stem Cell Transplant Stem Cell Transplant Complications Tolerance

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: Venetoclax, Hematopoietic Cell Transplantation Conditioning Regimen, Kidney Transplant, Hematopoietic Cell Transplantation.
Кому может быть актуально: Состояния в реестре: Kidney Failure Chronic, Stem Cell Transplant, Stem Cell Transplant Complications, Tolerance. Базовые параметры: 18 лет — 70 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

Addition of Venetoclax to Combined Reduced Intensity Hematopoietic Stem Cell and Kidney Transplantation for Patients With Chronic Kidney Disease and Hematologic Malignancy

Обзор

The primary objective is to assess the safety of the addition of venetoclax to reduced intensity conditioning for HLA-matched and haploidentical combined HSC and kidney transplantation as measured by stable full donor hematopoiesis and absence of CTCAE grade IV or V toxicity attributable to venetoclax.

Вмешательства

Препарат Venetoclax
Venetoclax 400mg orally once daily on days -8 through -1 with daily monitoring for tumor lysis syndrome. Venetoclax tablets will be swallowed (not crushed). Venetoclax dosing will not be repeated in the event of vomiting.
Процедура Hematopoietic Cell Transplantation Conditioning Regimen
Cytoxan Day -6 \& -5 Fludarabine Day -4, -3, -2 TBI Day -1
Процедура Kidney Transplant
Living donor kidney transplant
Процедура Hematopoietic Cell Transplantation
Donor bone marrow (target of 4 x 108 nucleated cells/kg of recipient ideal body weight) PBSC A goal dose of 5 x 106 CD34+ cells / kg of recipient actual body weight will be infused (minimum acceptable is 2 x 106 CD34+ cells / kg).

Первичные конечные точки

Incidence of full donor chimerism [Срок оценки: 24 months]
Incidence of Grade IV Toxicity due to Venetoclax [Срок оценки: Days -8 to Days -1]
Incidence of Grade V Toxicity due to Venetoclax [Срок оценки: Days -8 to Days -1]

Вторичные конечные точки (6)

Incidence of acute renal allograft rejection [Срок оценки: 24 months]
Incidence of delayed renal allograft rejection [Срок оценки: 24 months]
Incidence of acute GVHD [Срок оценки: 24 months]
Incidence of Chronic GVHD [Срок оценки: 24 months]
Patient Survival Rate [Срок оценки: 24 months]
Allograft Survival Rate [Срок оценки: 24 months]

Критерии участия

Recipient Inclusion Criteria:

Patient ages 18-70
Underlying hematological malignancy which is deemed as being potentially curable with allogeneic bone marrow or PBSC transplantation by the BMT voting team.
Hematological malignancies include, but are not limited to: acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), chronic myelogenous leukemia (CML), chronic lymphocytic leukemia (CLL), non-Hodgkin lymphoma (NHL), Hodgkin lymphoma, multiple myeloma (MM), myelodysplastic syndrome (MDS. Patient should be in a partial (PR) or complete remission (CR) at the time of the transplant.
Existence of an HLA-matched or haploidentical relative who passes standard donor evaluations for bone marrow and kidney donation
LVEF > 40% as measured by echocardiography or MUGA
FEV1, FVC, and DLCO > 50% of predicted as measured by standard PFTs
Total bilirubin < 2.0 (unless diagnosis of Gilbert's or hemolysis is made) and AST, ALT, alkaline phosphatase all < 5x institutions upper limit of normal
ABO compatibility in the host vs. graft direction
Men and women of reproductive potential must agree to use a reliable method of birth control during the treatment, and women should do so for a period of 1 year following the transplant.
Participants should be on dialysis or have a CrCl ≤ 35 ml/min
Life expectancy greater than 6 months
Recipient ability to understand and provide informed consent

Donor Inclusion Criteria:

HLA matched or haploidentical relative as defined by 3/6, 4/6, or 5/6 HLA-matched at HLA -A, -B, or -DRB1 who is 18-70 years of age
ECOG performance status 0 or 1
Excellent health per conventional pre-donor history (medical and psychosocial evaluation)

Acceptable laboratory parameters (hematology in normal or near-normal range; liver function < 3 times the upper limit of normal and normal creatinine)
Compatible ABO blood group
Negative donor lymphocyte cross match
No positive testing for active viral infection (Hepatitis B, Hepatitis C, HIV)
Donor ability to understand and provide informed consent
Meets standard institutional criteria for both bone marrow or peripheral blood stem cell (PBSC) and kidney donation