Идёт набор NCT06781515

Assessment of Disease Burden in Hairy Cell Leukemia

Без фазы С лечением Hairy Cell Leukemia

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: Peripheral and BM blood sample.
Кому может быть актуально: Состояния в реестре: Hairy Cell Leukemia. 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: Италия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

Drug-free, single-center, prospective observational pilot study in hairy Cell Leukemia patients

Подробное описание

The V600E gene lesion of B-raf, specific and almost always present in patients with hairy cell leukemia, correlates with the presence of neoplastic cells, therefore of active disease. The measurement of the fractional abundance of the mutated gene, by ddPCR, could therefore constitute a method of molecular assessment of the minimal residual disease. In addition, the values of fractional abundance (FA) of the mutated allele obtained can be integrated coherently in patients' clinical context, along with their PB counts and BM findings.

Primary objective Verify whether the absence of mutation at the end of treatment, indicative of a state of complete molecular response to therapy, can represent a predictor of long treatment-free survival.

Secondary objectives Verify the association between the absence of mutation and the duration of response in patients who do not need treatment for at least 5 years after only one treatment with purine analogues (cladribine and pentostatin) and judged in CR according to current criteria.

Вмешательства

Другое Peripheral and BM blood sample
Peripheral and BM blood samples will be analyzed with the ddPCR method

Первичные конечные точки

Progression Free Survival (PFS) [Срок оценки: through study completion, an average of 4 years]
Time to next treatment [Срок оценки: through study completion, an average of 4 years]
Correlation between the share of mutated allele (fractional abundance) with the response to the treatment.Correlation between the share of mutated allele (fractional abundance) with the response to the treatment. [Срок оценки: through study completion, an average of 4 years]

Вторичные конечные точки (1)

mutational pattern of B-raf i [Срок оценки: through study completion, an average of 4 years]

Критерии участия

Критерии включения

Histologically confirmed diagnosis of HCL patients:

newly diagnosed and candidates for first-line cytoreductive treatment with analogues purines or
in relapse after a previous line of treatment, with indication for rescue therapy (repetition of a purine analogue; use of targeted or innovative drugs), except splenectomy or
in CR for at least 5 years after a first line of treatment, in the absence of clinical alterations indicative of a state of hematological relapse, or in any case in the absence of an indication for a new line of cytoreductive therapy (time-to-next treatment exceeding 5 years).
Age ≥ 18 years at enrollment
Signature of written informed consent