Study to Assess Change in Disease Activity and Adverse Events of Oral Venetoclax With Intravenous (IV) Obinutuzumab in Adult Participants With Recurring Chronic Lymphocytic Leukemia (CLL)

Официальное название

A Multicenter, Open-Label, Phase 2 Study to Evaluate the Efficacy and Safety of Venetoclax-Obinutuzumab Retreatment in Patients With Recurring Chronic Lymphocytic Leukemia

Обзор

Chronic lymphocytic leukemia (CLL) is the most common leukemia (cancer of blood cells). The purpose of this study is to assess retreatment with venetoclax-obinutuzumab (VenG) in participants previously treated with fixed duration first-line (IL) therapy of venetoclax in combination with an anti-CD20 antibody +/- X (where X is any additional drug). Adverse events and change in disease activity will be assessed. Venetoclax is an approved drug for the treatment of CLL. Study doctors put the participants in 1 of 2 groups, called cohorts, based on when symptoms of CLL came back after previous treatment in first-line. Approximately 75 adult participants with CLL who have been treated with venetoclax in combination with an anti-CD20 antibody +/- X will be enrolled in the study in approximately 60 sites worldwide. Participants will receive intravenous (IV) obinutuzumab + oral venetoclax (VenG) in 28-day cycles for a total of 6 cycles per cohort, followed by 6 to 18 cycles of venetoclax alone, for a total treatment of 12 to 24 cycles, depending on the cohort. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Вмешательства

• Препарат Venetoclax
  Oral tablet
• Препарат Obinutuzumab
  Intravenous (IV) infusion

Первичные конечные точки

• Overall response (OR) in Cohort 1 after end of combination treatment [Срок оценки: 9 months]

Вторичные конечные точки (9)

• OR in Cohort 1 after end of combination treatment [Срок оценки: 9 months]
• OR in Cohort 1 after end of treatment [Срок оценки: 15 months]
• Time to Response (TTR) in Cohort 1 [Срок оценки: 15 months]
• Duration of Response (DOR) in Cohort 1 [Срок оценки: 15 months]
• Time to Next Treatment (TTNT) for CLL in Cohort 1 [Срок оценки: 15 months]
• Progression-free Survival (PFS) in Cohort 1 [Срок оценки: 15 months]
• Overall Survival (OS) in Cohort 1 [Срок оценки: 15 months]
• Percentage of Participants with Undetectable Minimal Residual Disease (uMRD) rate (<10^-4) in Cohort 1 after end of combination treatment [Срок оценки: 9 months]
• Percentage of Participants with Undetectable Minimal Residual Disease (uMRD) rate (<10^-4) in Cohort 1 after end of treatment [Срок оценки: 15 months]

Критерии участия

Критерии включения

• Documented diagnosis of chronic lymphocytic leukemia (CLL) that requires treatment for CLL according to International Workshop for Chronic Lymphocytic Leukemia (iwCLL) 2018 criteria.
• Previously completed venetoclax + anti-CD20 antibody +/- X regimen as a fixed duration first-line (1L) therapy and achieved documented response, defined as complete remission, complete remission with incomplete marrow recovery, partial remission, or nodular partial remission.
• More than 24 months (Cohort 1) or 12-24 months (Cohort 2) have elapsed between last dose of venetoclax and disease progression after completion of 1L treatment.

Критерии исключения

\- Received intervening treatment for CLL after completing previous treatment with a venetoclax + anti-CD20 antibody +/- X regimen.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Германия · 17 центров

• Stauferklinikum Schwaebisch Gmuend /ID# 230176 — Mutlangen
• Universitaetsklinikum Ulm /ID# 230164 — Ulm
• VK&K Studien GbR /ID# 230198 — Landshut
• Muenchen Klinik Schwabing /ID# 230197 — Munich
• Universitaetsmedizin Rostock /ID# 230190 — Rostock
• Universitaetsklinikum Koeln /ID# 230296 — Cologne
• Universitaetsklinikum des Saarlandes /ID# 248747 — Homburg
• BAG Freiberg-Richter, Jacobasch, Illmer, Wolf /ID# 230168 — Dresden
• … и ещё 9 центров

США · 15 центров

• Moores Cancer Center at UC San Diego /ID# 230157 — La Jolla
• Winship Cancer Institute of Emory University /ID# 230643 — Atlanta
• Des Moines Oncology Research Association /ID# 232606 — Des Moines
• Dana-Farber Cancer Institute /ID# 230061 — Boston
• Henry Ford Hospital /ID# 230268 — Detroit
• St. Lukes Hospital of Duluth /ID# 250021 — Duluth
• Hattiesburg Clinic /ID# 233443 — Hattiesburg
• Summit Medical Group-Florham Park /ID# 244782 — Florham Park
• … и ещё 7 центров

Австрия · 7 центров

• Universitaetsklinikum St. Poelten /ID# 243493 — Sankt Pölten
• Medizinische Universitaet Wien /ID# 230013 — Vienna
• Klinik Ottakring /ID# 230019 — Vienna
• Landeskrankenhaus Hochsteiermark, Standort Leoben /ID# 267569 — Leoben
• Ordensklinikum Linz GmbH Barmherzige Schwestern /ID# 249516 — Linz
• Landeskrankenhaus Salzburg-Universitaetsklinikum der PMU (LKH) /ID# 230015 — Salzburg
• Hanusch Krankenhaus /ID# 230010 — Vienna

Израиль · 4 центра

• Hadassah /ID# 245059 — Jerusalem
• The Chaim Sheba Medical Center /ID# 243219 — Ramat Gan
• Tel Aviv Sourasky Medical Center /ID# 243218 — Tel Aviv
• Rabin Medical Center. /ID# 243220 — Petah Tikva

Австралия · 3 центра

• Royal Adelaide Hospital /ID# 229898 — Adelaide
• Northern Hospital Epping /ID# 229847 — Epping
• Peter MacCallum Cancer Ctr /ID# 254634 — Melbourne

Бразилия · 3 центра

• Hospital de Clinicas de Porto Alegre /ID# 243657 — Porto Alegre
• Hospital Nove de Julho /ID# 243658 — São Paulo
• Instituto de Ensino e Pesquisas Sao Lucas /ID# 243659 — São Paulo

Великобритания · 3 центра

• Blackpool Victoria Hospital /ID# 267280 — Blackpool
• Norfolk and Norwich University Hospitals NHS Foundation Trust /ID# 250733 — Norwich
• Leeds Teaching Hospitals NHS Trust /ID# 250732 — Leeds

Болгария · 2 центра

• UMHAT Sveti Georgi EAD /ID# 272321 — Plovdiv
• MHAT Hristo Botev /ID# 229687 — Vratsa

Италия · 2 центра

• A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 229504 — Turin
• Azienda Ospedaliera Santa Maria Terni /ID# 229442 — Terni

Румыния · 1 центр

• Fundeni Clinical Institute /ID# 241614 — Bucharest

Испания · 1 центр

• Hospital Universitario de la Princesa /ID# 229665 — Madrid

Идентификаторы

NCT: NCT04895436 · M20-356 · 2023-504599-10-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗