A Study to Evaluate the Risk of Tumor Lysis Syndrome (TLS) in Adult Participants Receiving Oral Venetoclax in Combination With Intravenously Infused Obinutuzumab or Oral Acalabrutinib for Previously Untreated Chronic Lymphocytic Leukemia (CLL)

Официальное название

A Prospective, Open-Label, Phase IIb/III Study to Evaluate the Risk of TLS and Optimization of the Initiation of Venetoclax in Combination With Obinutuzumab or Acalabrutinib With Different Ramp- Up Periods in Previously Untreated Subjects With CLL

Обзор

Chronic lymphocytic leukemia (CLL) is the most common leukemia (cancer of blood cells). The purpose of this study is to assess the safety of venetoclax in combination with obinutuzumab or acalabrutinib in the treatment of CLL. Adverse events and change in disease activity will be assessed. Venetoclax in combination with obinutuzumab or acalabrutinib is being investigated in the treatment of CLL. Study doctors put the participants in 1 of 4 groups, called treatment arms. Participants will receive oral venetoclax in combination with intravenously (IV) infused obinutuzumab or oral acalabrutinib at in different dosing schemes as part of treatment. Approximately 170 adult participants with CLL who are being treated with venetoclax will be enrolled in the study in approximately 80 sites worldwide. Participants in Arm A will receive oral venetoclax in combination with IV infused obinutuzumab, with a 5 week venetoclax ramp up. Participants in Arm B will receive oral venetoclax in combination with oral acalabrutinib, with a 5 week venetoclax ramp up. Participants in Arm C and Arm D will receive oral venetoclax in combination with oral acalabrutinib, with differing venetoclax ramp up periods. The total study duration is approximately 28 months. 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 Acalabrutinib
  Oral: Tablet
• Препарат Obinutuzumab
  Intravenous Infusion

Первичные конечные точки

• Part 1: Percentage of Participants with Treatment-Emergent Laboratory Tumor Lysis Syndrome (TLS)-Venetoclax [Срок оценки: Up to 28 Months]
• Part 1: Percentage of Participants with Hyperkalemia-Venetoclax [Срок оценки: Up to 28 Months]

Вторичные конечные точки (5)

• Part 1: Percentage of Participants with Treatment-Emergent Laboratory TLS [Срок оценки: Up to 28 Months]
• Part 1: Percentage of Participants with Hyperkalemia [Срок оценки: Up to 28 Months]
• Part 1: Percentage of Participants with Treatment-Emergent TLS-Related Events [Срок оценки: Up to 28 Months]
• Part 1: Percentage of Participants with Adverse Events (AE) of TLS [Срок оценки: Up to 28 Months]
• Part 1: Percentage of Participants with Reduction of Tumor Burden from Baseline [Срок оценки: Up to 28 Months]

Критерии участия

Критерии включения

• Diagnosis of documented, previously untreated, chronic lymphocytic leukemia (CLL) requiring treatment according to the 2018 international workshop on chronic lymphocytic leukemia (iwCLL) criteria and have a life expectancy of > 6 months.
• Previously untreated small lymphocytic lymphoma (SLL) meeting the 2018 iwCLL criteria for treatment will also be equally considered as CLL for eligibility, screening, treatment and evaluation.
• Eastern Cooperative Oncology Group (ECOG) performance status <= 2.
• Adequate marrow function independent of growth factor or transfusion support within 2 weeks of screening, unless cytopenia is due to marrow involvement of CLL as listed in the protocol.
• Creatinine clearance (CrCl) >= 30 mL/min using the Cockcroft-Gault formula are eligible for inclusion.

Критерии исключения

\- Active/uncontrolled infection, no Richter's transformation, no active immune thrombocytopenia.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 32 центра

• Arizona Oncology - Tucson - Rudasill /ID# 267552 — Tucson
• Southern VA Health Care System /ID# 266254 — Tucson
• UCSF FRESNO/Community Cancer Institute /ID# 270874 — Clovis
• Valkyrie Clinical Trials /ID# 268151 — Los Angeles
• Rocky Mountain Cancer Centers - Aurora /ID# 267549 — Aurora
• Yale University School of Medicine /ID# 266224 — New Haven
• Malcolm Randall V.A. Medical Center /ID# 267825 — Gainesville
• Cancer Specialists of North Florida - Jacksonville - AC Skinner Parkway /ID# 266713 — Jacksonville
• … и ещё 24 центра

Франция · 10 центров

• Centre Hospitalier Régional Metz Thionville - Hôpital de Mercy /ID# 266852 — Metz
• Hopitaux Universitaires Henri Mondor - Hopital Henri Mondor /ID# 266270 — Créteil
• Hopitaux Universitaires Paris Centre-Hopital Cochin /ID# 267438 — Paris
• Centre Hospitalier Universitaire de Saint Etienne - Hopital Nord /ID# 266319 — St-Priest-en-Jarez
• Centre Antoine-Lacassagne /ID# 266894 — Nice
• Centre Hospitalier de la Côte Basque /ID# 266847 — Bayonne
• Centre Hospitalier Métropole Savoie - Site Hôpital de Chambéry /ID# 266854 — Chambéry
• CHU Amiens-Picardie Site Sud /ID# 266849 — Amiens
• … и ещё 2 центра

Сербия · 7 центров

• Clinical Hospital Center Zvezdara /ID# 266560 — Belgrade
• University Clinical Center Serbia /ID# 266579 — Belgrade
• Clinical Hospital Center - Bežanijska Kosa /ID# 266567 — Belgrade
• University Clinical Center Nis /ID# 266580 — Niš
• University Clinical Center Kragujevac /ID# 266568 — Kragujevac
• Institute for Oncology of Vojvodina /ID# 266556 — Kamenitz
• University Clinical Center Vojvodina /ID# 266674 — Novi Sad

Испания · 6 центров

• Complejo Hospitalario Universitario de Santiago (CHUS) /ID# 267164 — Santiago de Compostela
• Hospital Universitario Puerta de Hierro - Majadahonda /ID# 266967 — Majadahonda
• Clinica Universidad de Navarra - Pamplona /ID# 267762 — Pamplona
• CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 266969 — Madrid
• Hospital MD Anderson Cancer Center Madrid /ID# 267167 — Madrid
• Hospital Universitario Virgen del Rocio /ID# 266968 — Seville

Греция · 5 центров

• Olympion General Clinic /ID# 266819 — Pátrai
• Evangelismos Hospital /ID# 266815 — Athens
• General Hospital of Athens Laiko /ID# 266813 — Athens
• University General Hospital Attikon /ID# 266814 — Athens
• University General Hospital of Alexandroupoli /ID# 266816 — Alexandroupoli

Австралия · 4 центра

• Calvary Mater Newcastle /ID# 267408 — Waratah
• Townsville University Hospital /ID# 266954 — Townsville
• St Vincent's Hospital - Melbourne /ID# 270027 — Fitzroy
• Royal Perth Hospital /ID# 266906 — Perth

Тайвань · 4 центра

• Kaohsiung Chang Gung Memorial Hospital /ID# 267046 — Kaohsiung City
• China Medical University Hospital /ID# 267018 — Taichung
• National Taiwan University Hospital /ID# 267017 — Taipei
• Linkou Chang Gung Memorial Hospital /ID# 267045 — Taoyuan City

Пуэрто-Рико · 1 центр

• Pan American Center for Oncology Trials /ID# 266243 — Rio Piedras

Великобритания · 1 центр

• Nottingham City Hospital /ID# 266991 — Nottingham

Идентификаторы

NCT: NCT06428019 · M24-287 · 2024-512147-23-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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