Extension Study to Provide Continued Treatment for Patients With Hematologic Malignancies Previously Enrolled in Studies With Tafasitamab

Официальное название

An Open-Label, Multicenter, Extension Study to Provide Continued Treatment for Patients With Hematologic Malignancies Previously Enrolled in Studies With Tafasitamab

Обзор

This extension study is designed to enroll participants with hematologic malignancies who are receiving clinical benefit from tafasitamab treatment in a parent study with tafasitamab..

Вмешательства

• Препарат Tafasitamab
  Treatment with tafasitamab is as per the treatment dose and schedule they received in the parent protocols.

Первичные конечные точки

• Number of participants with Treatment-emergent Adverse Events (TEAEs) [Срок оценки: up to approximately 2 years]

Критерии участия

Критерии включения

• Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
• Having been enrolled and is still receiving treatment with tafasitamab at the end of a parent tafasitamab clinical study.
• Is tolerating tafasitamab treatment at the dose specified in the parent protocol as assessed by the Investigator.
• Is in complete/partial response or stable disease and is receiving clinical benefit from treatment with tafasitamab in the parent study, as assessed by the Investigator.
• Has demonstrated compliance, as assessed by the Investigator, with the parent protocol requirements.
• Willingness and ability to comply with scheduled visits, treatment plans, and any other study procedures indicated in this protocol.

Критерии исключения

• Patient who is legally institutionalized, or under judicial protection.
• Has met one or more criteria for permanent tafasitamab treatment discontinuation as stipulated in the parent protocol.
• Able to access tafasitamab outside a clinical study.
• Patient with an uncontrolled intercurrent illness or any concurrent condition that, in the Investigator's opinion, would jeopardize the safety of the patient or compliance with the protocol.
• A female patient who is pregnant confirmed by a pregnancy test prior to enrollment, breastfeeding, or a woman of childbearing potential (WOCBP) who does not agree to follow the contraceptive guidance during the treatment period and for at least 3 months after the last dose of study treatment, and does not refrain from donating oocytes during this period.
• A male patient who does not agree to use contraception as detailed in the contraceptive guidance during the treatment period and for at least 3 months after the last dose of study treatment (if they have a heterosexual partner who is a woman of childbearing potential) and who does not refrain from donating sperm during this period.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Венгрия · 1 центр

• Petz Aladar County Teaching Hospital — Győr

Италия · 1 центр

• Hospital S.M. Terni University of Perugia — Terni

South Korea · 1 центр

• Samsung Medical Center — Seoul

Испания · 1 центр

• Clinica Universitad de Navarra — Pamplona

Turkey (Türkiye) · 1 центр

• Gazi University Hospital Gazi University Faculty of Medicine — Ankara

Идентификаторы

NCT: NCT06465433 · MOR208C216 · 2022-500765-27-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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