Идёт набор NCT03852407

Allogeneic Hematopoietic Cell Transplantation From HLA-matched Donor After Flu-Mel-PTCy Versus Flu-Mel-ATG Reduced-intensity Conditioning

Фаза II С лечением Acute Myeloid Leukemia in Remission Myelodysplastic Syndromes Chronic Myeloid Leukemia in Remission Myeloproliferative 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: В протоколе указаны: Thymoglobulin, Melphalan, Fludarabine, Cyclophosphamid.
Кому может быть актуально: Состояния в реестре: Acute Myeloid Leukemia in Remission, Myelodysplastic Syndromes, Chronic Myeloid Leukemia in Remission, Myeloproliferative Syndrome. Базовые параметры: 18 лет — 75 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: Бельгия
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

Allogeneic Hematopoietic Cell Transplantation From HLA-matched Donor After Flu-Mel-PTCy Versus Flu-Mel-ATG Reduced-intensity Conditioning: a Phase II Randomized Study From the Belgian Hematology Society (BHS)

Обзор

The present project aims at comparing two conditioning regimens (FM-PTCy vs FM-ATG). The hypothesis is that one or the two regimens will lead to a 2-year cGRFS rate improvement from 30% (the cGRFS rate with FM without ATG/PTCy) to 45% (Pick-a-winner phase 2 randomized study).

Подробное описание

This study is a multicenter, randomized, open-label, phase II study pick-a-winner study, comparing 2 conditioning regimens. A total of 114 eligible patients with HLA-matched donors will be randomized 1:1 between the FM-PTCy arm and the FM-ATG arm, with stratification for donor type (related or unrelated). The recruitment period is 3 years with a 5-year follow-up plus a 10-year additional long-term follow-up (for GVHD status, disease status, second malignancy and QOL). The whole study will be completed within 18 years.

Вмешательства

Препарат Thymoglobulin
ATG: 2.5 mg /kg/day on day -2 and -1 (day 0 is allogenic transplantation)
Препарат Melphalan
100mg/m² on day -2
Препарат Fludarabine
30mg/m² on days -6, -5, -4, -3, and -2
Препарат Cyclophosphamid
50 mg/kg on days +3 and +4.

Первичные конечные точки

Current GVHD-free, relapse-free survival (cGRFS) [Срок оценки: 15 years (the primary endpoint will be first assessed after 191 events have been reached)]

Вторичные конечные точки (8)

cGRFS according donor [Срок оценки: 15 years]
Relapse/progression rate [Срок оценки: 15 years]
Rate aGVHD [Срок оценки: 6 months]
Rate cGVHD [Срок оценки: 24 months]
Rate of Nonrelapse Mortality (NRM) [Срок оценки: 15 years]
Rate of Leukemia Free Survival (LFS) [Срок оценки: 15 years]
Rate of Overall Survival (OS) [Срок оценки: 15 years]
Proportion of patients alive [Срок оценки: 15 years]

Критерии участия

Критерии включения

Patients V.1.1. Diseases

Hematological malignancies confirmed histologically:

AML in morphological CR or not in morphological CR but not rapidly progressing (i.e. no need to give treatments such as hydroxyurea to maintain WBC count < 10 000 x109/mL);
MDS;
CML in CP or AP;
MPD not in blast crisis,
MDS/MPD overlap,
ALL in CR;
Multiple myeloma;
CLL;
Non-Hodgkin's lymphoma (aggressive NHL should have chemosensitive disease);
Hodgkin's disease with chemosensitive disease or responding to checkpoint inhibitors.

\* Clinical situations

Theoretical indication for a standard allo-transplant, but not feasible because:
Age > 50 yrs;
Unacceptable end organ performance;
The physician's decision;
The patient's decision

Underlying 'lower risk' disease, for which Reduced Intensity Conditioning is preferred (eg CLL, MCL)

\* Other inclusion criteria

Male or female; fertile patients must use a reliable contraception method;
Age 18-75 yrs (children of any age are not allowed in the protocol);
Informed consent given by patient or his/her guardian if indicated.

Donors

Male or female;
Any age;
Human Leukocyte Antigen (HLA)-identical sibling donor or 10 of 10 (HLA-A, -B, -C, -DRB1, and -DQB1) HLA allele matched unrelated donor;
Weight > 15 Kg (because of leukapheresis);
Fulfills criteria for allogeneic Peripheral Blood Stem Cell (PBSC) donation according to standard procedures;
Informed consent given by donor or his/her guardian if indicated, as per donor center standard procedures.

Критерии исключения

Patients

Any condition not fulfilling inclusion criteria;
Human Immunodeficiency Virus positive;
Non-hematological malignancy(ies) (except non-melanoma skin cancer) active < 3 years before Hematopoietic Cell Transplantation (HCT).
Life expectancy severely limited by disease other than malignancy;
Central Nervous System involvement with disease refractory to intrathecal chemotherapy.
Terminal organ failure, except for renal failure (dialysis acceptable)

Cardiac: Symptomatic coronary artery disease; ejection fraction <40%; uncontrolled arrhythmia, uncontrolled hypertension;
Pulmonary: Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)< 40% and/or receiving supplementary continuous oxygen, Forced Expiratory Volume in 1 Second (FEV1)< 40%;
Hepatic: Fulminant liver failure, cirrhosis of the liver with evidence of portal hypertension, alcoholic hepatitis, esophageal varices, a history of bleeding esophageal varices, hepatic encephalopathy, uncorrectable hepatic synthetic dysfunction evinced by prolongation of the prothrombin time, ascites related to portal hypertension, bacterial or fungal liver abscess, biliary obstruction, chronic viral hepatitis with total serum bilirubin >3 mg/dL, and symptomatic biliary disease;
Uncontrolled infection;
Karnofsky Performance Score <70%;
Patient is a fertile man or woman who is unwilling to use contraceptive techniques during and for 12 months following treatment;
Patient is a female who is pregnant or breastfeeding;
Any condition precluding the use of melphalan or Thymoglobulin;

Donors