Идёт набор NCT07202052

Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy Platform Trial (RATIONAL-PT)

Фаза II / Фаза III С лечением Myeloma Non-Hodgkin's Lymphoma 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: Intravenous immunoglobulin, Trimethoprim / Sulfamethoxazole, Amoxicillin clavulanic acid, Intravenous immunoglobulin (IVIG).
Кому может быть актуально: Состояния в реестре: Myeloma, Non-Hodgkin's Lymphoma, 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: Австралия
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

A Randomised Platform Trial Evaluating the Role of Interventions to Prevent Infection in Patients With Acquired Hypogammaglobulinemia Secondary to Haematological Malignancies - RATIONAL-PT (Core)

Обзор

This is an adaptive platform study to find out how safe and effective different strategies are in comparison to each other, for preventing infection in patients with blood cancers. It is a comparison between Immunoglobulin and antibiotics use.

Подробное описание

This study is being conducted to find out how safe and effective different strategies of infection prevention are in comparison to each other, for preventing infection in patients with blood cancers. The best way to find out this information is to directly compare the effect of different treatment strategies in patients with blood cancers. We want to know how these different treatments impact on your health and your use of healthcare services.

This research project uses an Adaptive Platform Design. This design allows the researchers to compare multiple infection prevention strategies within the same trial at the same time (rather than running separate trials), to analyse results as the trial occurs and to add new research questions during the course of the trial.

The treatments that you may receive as part of the study will be determined by which domain(s) of the platform you participate in. By combining data collected within each domain as part of the platform, the researchers can investigate and compare treatment strategies and infection outcomes across a broader range of participants.

Вмешательства

Биопрепарат Intravenous immunoglobulin
(IVIg) intravenous immunoglobulin every 4 weeks ± 1 week at a dose of 0.4g/kg, modified to achieve an (IgG) immunoglobulin G trough level of at least lower limit of age-specific serum IgG reference range; or SCIg, weekly, may be used in patients who meet local criteria for home-based self-administration in centres with established SCIg programs. Dosing is usually given at 100mg/kg/week, modified to achieve an IgG steady state level of at least the lower limit of the serum reference range. A load
Препарат Trimethoprim / Sulfamethoxazole
Once daily trimethoprim-sulfamethoxazole (co-trimoxazole) 160mg/800mg. Doxycycline 100mg daily as an alternative for patients with hypersensitivity to co-trimoxazole.
Препарат Amoxicillin clavulanic acid
Patients will be provided with amoxycillin/clavulanic acid 1750-2000mg/250mg and ciprofloxacin 750 mg to keep at home for initial use if symptoms of infection develop, with immediate review by their treating clinical team, or nearest emergency department or medical practitioner with phone contact to treating team if most practical. Clindamycin 600 mg is permitted as an alternative to amoxycillin/clavulanic acid for patients with hypersensitivity to penicillin. Ciprofloxacin is omitted for partic
Биопрепарат Intravenous immunoglobulin (IVIG)
Arm A: Low dose (IgRT) immunoglobulin replacement therapy: Participants will be treated with intravenous immunoglobulin monthly (every 4 weeks ± 1 week) at a dose of 0.25g/kg. No dose adjustment for trough serum IgG levels is required. Arm B: Usual dose: Participants will be treated with intravenous immunoglobulin monthly (every 4 weeks ± 1 week) at a dose of 0.4g/kg, modified to achieve an IgG trough level of at least lower limit of age-specific serum IgG reference range.

Первичные конечные точки

Event-free survival (EFS) [Срок оценки: 12 months following randomisation (or, in domains with a single treatment arm, time from registration)]

Вторичные конечные точки (12)

Occurrence of at least one Grade 3 or higher infection(s) from randomisation to 12 months [Срок оценки: 12 months following randomisation (or, in domains with a single treatment arm, time from registration)]
Occurrence of one or more clinically documented infections (symptoms/signs of infection requiring antimicrobial treatment) from randomisation to 12 months. [Срок оценки: 12 months following randomisation (or, in domains with a single treatment arm, time from registration)]
Number of clinically documented infections (symptoms/signs of infection requiring antimicrobial treatment) from randomisation to 12 months. [Срок оценки: 12 months following randomisation (or, in domains with a single treatment arm, time from registration)]
Occurrence of one or more microbiologically documented infections from randomisation to 12 months. [Срок оценки: 12 months following randomisation (or, in domains with a single treatment arm, time from registration)]
Number of microbiologically documented infections from randomisation to 12 months. [Срок оценки: 12 months following randomisation (or, in domains with a single treatment arm, time from registration)]
All-cause mortality at 12 months [Срок оценки: 12 months following randomisation (or, in domains with a single treatment arm, time from registration)]
Infection-related mortality at 12 months [Срок оценки: 12 months following randomisation (or, in domains with a single treatment arm, time from registration)]
Time free from hospitalisation with antimicrobial administration with therapeutic intent from randomisation to 12 months. [Срок оценки: 12 months following randomisation (or, in domains with a single treatment arm, time from registration)]
Occurrence of one or more treatment-related adverse events [Срок оценки: 12 months following randomisation (or, in domains with a single treatment arm, time from registration)]
Number of treatment-related adverse events. [Срок оценки: 12 months following randomisation (or, in domains with a single treatment arm, time from registration)]
Isolation of fluoroquinolone resistant organisms, co-trimoxazole resistant organisms, extended spectrum beta lactamases or multidrug resistant organisms from randomisation to 12 months [Срок оценки: 12 months following randomisation (or, in domains with a single treatment arm, time from registration)]
Number of infections with fluoroquinolone resistant organisms, co-trimoxazole resistant organisms, extended spectrum beta lactamases or multidrug resistant organisms isolated from randomisation to 12 months [Срок оценки: 12 months following randomisation (or, in domains with a single treatment arm, time from registration)]

Критерии участия

Критерии включения

Aged greater than or equal to 18 years of age
Diagnosis of haematological malignancy, including (CLL) chronic lymphocytic leukemia, (MM) multiple myeloma or (NHL) non-Hodgkin's lymphoma.
Eligible to receive or currently receiving Ig (IV or subcutaneous - SCIg) replacement for history of recurrent or severe infection(s) and IgG less than the lower limit of the reference range (excluding paraprotein) OR IgG<4g/L (excluding paraprotein)
Life expectancy > 12 months
Able to give informed consent