Obinutuzumab in Combination With Lenalidomide in Relapsed or Refractory Follicular Lymphoma in Real World Study

Официальное название

Efficacy and Safety of Obinutuzumab in Combination With Lenalidomide in Patients With Relapsed and Refractory Follicular Lymphoma (R/R FL): A Prospective Observational Study

Обзор

This study is planned to prospectively observe and verify the efficacy and safety of induction therapy with obinutuzumab in combination with lenalidomide followed by maintenance therapy with obinutuzumab and lenalidomide in patients with R/R FL in a real-world setting in a Chinese population.

Подробное описание

Available data have shown that the combination of obinutuzumab and lenalidomide has shown good efficacy and safety in patients with R/R FL, but the efficacy and safety in Chinese patients remain to be verified.

This study is planned to prospectively observe and verify the efficacy and safety of induction therapy with obinutuzumab in combination with lenalidomide followed by maintenance therapy with obinutuzumab and lenalidomide in patients with R/R FL in a real-world setting in a Chinese population.

The main questions it aims to answer are:

* To assess the ORR in the R/R FL patient population treated with the combination of obinutuzumab and lenalidomide * To assess CRR, PFS, EFS, DOR, OS, and safety in patients with R/R FL treated with the combination of obinutuzumab and lenalidomide

Participants in this study will not and should not result in any intervention to the patient's treatment and visits. All treatments and visits for patients will be at the physician's discretion according to clinical practice

Первичные конечные точки

• overall response rate（ORR） [Срок оценки: 24 weeks]

Вторичные конечные точки (6)

• 2-year Progression free survival（PFS24） [Срок оценки: Up to 4.5 years]
• 2-year Event-free survival（EFS24） [Срок оценки: Up to 4.5 years]
• Complete response (CR) [Срок оценки: 2.5 years]
• Duration of response (DoR) [Срок оценки: Up to 4.5 years]
• Overall survival (OS) [Срок оценки: Up to 4.5 years]
• Safety(Proportion of Grade 3-4 Hematologic and Non-Hematologic Toxicities) [Срок оценки: 4.5 years]

Критерии участия

Patients must meet the following criteria for study entry::

• Signed Informed Consent Form
• Age ≥ 18 years at enrollment
• At least one prior line of systemic (Stage III-IV) follicular lymphoma therapy
• Relapsed or refractory to front-line anti-lymphoma therapy; refractory is defined as: tumor shrinkage of less than 50% or disease progression after 4 cycles of standard regimen chemotherapy; response to standard regimen chemotherapy, relapse within 24 months; 2 or more relapses, meeting one of the above criteria as refractory lymphoma.
• Conditional treatment with obinutuzumab in combination with lenalidomide

Критерии исключения

• Patients currently participating or planning to participate in any interventional clinical trial
• Any other reason that, in the opinion of the investigator, makes the patient unsuitable for this study

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Institute of Hematology and Blood Diseases Hospital ,Chinese Academy of Medical Sciences — Тяньцзинь

Идентификаторы

NCT: NCT05846763 · BDHFL2023

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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