Идёт набор NCT02677064

Identify Barriers to Allogeneic Hematopoietic Stem Cell Transplantation in Patients With Newly Diagnosed and Relapsed Acute Leukemia

— Наблюдательное Acute Leukemia Newly Diagnosed Relapsed

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: assessments.
Кому может быть актуально: Состояния в реестре: Acute Leukemia, Newly Diagnosed, Relapsed. Базовые параметры: 18 лет — 80 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

Observational Study to Identify Barriers to Allogeneic Hematopoietic Stem Cell Transplantation in Patients With Newly Diagnosed and Relapsed Acute Leukemia, Myelodysplastic Syndrome and Myelproliferative Neoplasms

Обзор

The investigators are doing this research study to assess the percentage of patients receiving stem cell transplantation for the type of blood cancer you have. They want to know how many patients get a transplant and why some patients do get a transplant while others do not. Also they want to explore why some patients elect not to undergo stem cell transplantation, when it is recommended by their physicians.

Подробное описание

Additional Arms have been added for MSK patients only. Patients with MDS and MPN Patients with Post-transplant Relapse of Acute Leukemia, MDS or MPN

Вмешательства

Другое assessments
All laboratory assessments performed on this study represent standard of care at our institution. HLA allele typing is performed by the center's HLA laboratory according to standard typing procedures.

Первичные конечные точки

number of patients who proceed to transplant [Срок оценки: 3 years]

Критерии участия

Критерии включения

Patients with newly diagnosed or relapsed acute leukemia. Patients undergoing reinduction due to primary induction failure are also eligible. Patients with acute leukemia will be enrolled to Arm A
Patients with diagnosis of MDS, MPN and MDS/MPN overlap who meet any of the following criteria (based on NCCN guidelines):
Clinically significant cytopenia of at least 2 cell lines affected; Hgb<10,
Platelet<100,000, absolute neutrophil count<1000
Bone marrow blasts >5% and any level of circulating blasts
Evidence of disease progression or no response to hypomethylating agents/immunosuppressive treatment or a clinical trial.
IPSS Intermediate-1 and higher
IPSS-R intermediate and higher
All cases of therapy related MDS with excess blasts
In patients with Myelofibrosis: Low risk disease by DIPSS with either refractory, transfusion dependent anemia, circulating blasts cells greater than 2%; or adverse cytogenetics and any patient with DIPSS-intermediate 1 and higher. For patients with post-PV and post-ET myelofibrosis, any patient with MYSEC-PM Intermediate-1 risk or higher is eligible.
Patients with acute leukemia or MDS/MPN who relapse after first allografts. Patients with post-transplant relapse will be enrolled to Arm C.
Patients 18 years of age or older and 80 years of age or younger
For the purposes of this protocol "relapse" is defined as re-emergence of the initial abnormal myeloid blast population (or blast equivalent) comprising 5% or more of marrow WBC or any amount prompting a therapeutic intervention targeting relapsed disease, including, but not limited to withdrawal of immunosuppression, targeted therapies, chemotherapy, etc.
Patients previously enrolled in Arm A or Arm B who experience post-transplant relapse are also eligible for enrollment onto Arm C