Surovatamig as Consolidation Therapy in Participants With Chronic Lymphocytic Leukaemia or Small Lymphocytic Lymphoma With Unmutated Immunoglobulin Heavy Chain Variable (IGHV)

Официальное название

A Phase III, Randomised, Open-label, Multicentre, Study of Surovatamig as Consolidation Therapy Versus Observation After First-line Induction Therapy in Participants With Chronic Lymphocytic Leukaemia or Small Lymphocytic Lymphoma With Unmutated IGHV (SOUNDTRACK-C1)

Обзор

The purpose of this study is to evaluate the therapeutic benefit and safety of subcutaneous (SC) Surovatamig monotherapy as consolidation therapy in patients with Chronic Lymphocytic Leukaemia (CLL)/ Small Lymphocytic Lymphoma (SLL) with unmutated IGHV (uIGHV).

Подробное описание

This is a Phase III global, randomised, open-label, multicentre study. The study will consist of 2 sequential parts- the Dose Optimisation and Safety Run-in part and the Phase-III part.

During the dose optimisation and safety run-in part, Surovatamig will be initiated in 2 dose levels. This part will help to determine the recommended phase III dose (RP3D) of Surovatamig to be used in Phase III part. Phase III would comprise of 2 arms, Arm A where the Surovatamig dose (RP3D) will be administered as a consolidation therapy (post standard of care \[SOC\] induction therapy) and Arm B where participants will be observed. In Phase 3 participants will be randomized in a 1:1 ratio to Arm A or Arm B.

Вмешательства

• Препарат Surovatamig
  Surovatamig will be administered as a subcutaneous injection.

Первичные конечные точки

• DOSRI- Number of participants with adverse events (AEs) and Serious Adverse Events (SAEs) [Срок оценки: Up to 5 years]
• Phase III- Progression Free Survival (PFS) [Срок оценки: Until disease progression or death (up to 5 years)]
• DOSRI- Number of participants with study intervention discontinuations, dose reductions and dose delays due to AEs [Срок оценки: Up to 5 years]

Вторичные конечные точки (12)

• Objective Response Rate (ORR) [Срок оценки: Up to 5 years]
• Complete Response rate (CR rate) [Срок оценки: Up to 5 years]
• Duration of response (DoR) [Срок оценки: Up to 5 years]
• DOSRI- PFS [Срок оценки: Until disease progression or death (up to 5 years)]
• Overall Survival (OS) [Срок оценки: Up to 5 years]
• Serum concentrations of Surovatamig [Срок оценки: At pre-defined intervals from date offirst dose (C1D1) up to 30 days from last dose (approximately 5 years)]
• Maximum concentration observed (Cmax) [Срок оценки: At pre-defined intervals from date of first dose up to 30 days from last dose (approximately 5 years)]
• Time to Maximum Concentration (tmax) [Срок оценки: At pre-defined intervals from date of first dose up to 30 days from last dose (approximately 5 years)]
• Trough concentration (Ctrough) [Срок оценки: At pre-defined intervals from date of first dose up to 30 days from last dose (approximately 5 years)]
• Number of participants with Anti-drug antibodies (ADA) [Срок оценки: At predefined intervals from the date of first dose to approximately 5 years]
• Phase III- PFS [Срок оценки: Until disease progression or death (up to 5 years)]
• Phase III- Number of participants with AEs and SAEs [Срок оценки: Up to 5 years]

Критерии участия

Критерии включения

• Documented diagnosis of CLL/SLL with genomic features defined by unmutated IGHV.
• Treatment received and response at the end of 1L (first-line) finite therapy.
• Participants with SLL (except those in CR in Phase III part) must have measurable disease (nodal or extranodal) with at least one measurable target lesion.
• ECOG performance status of 0 to 2.
• Adequate haematologic, liver, renal and cardiac function.
• Female participants: must be either women not of childbearing potential or must use a highly effective form of contraception.
• Male participants who intend to be sexually active with females of childbearing potential must agree to use barrier contraception (eg, condoms).

Критерии исключения

• Suspected or confirmed transformation of CLL/SLL to a more aggressive form of lymphoma (ie, Richter's transformation, prolymphocytic leukaemia, or DLBCL).
• Evidence of active or history of Central Nervous System (CNS) involvement by CLL/SLL.
• History of or ongoing confirmed progressive multifocal leukoencephalopathy.
• Participants who have any concurrent or history of malignancy.
• Participants with:
• Active or uncontrolled infection (including Epstein-Barr virus-EBV) requiring systemic therapy.
• Participants with known history of Heamophagocytic lymphohistiocytosis (HLH).
• Human Immunodeficiency Virus (HIV) infection, or participants with chronic or active infection with Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV).
• Major cardiac abnormalities.
• Prior CLL/SLL-specific therapies.
• Requires chronic immunosuppressive therapy for active autoimmune/inflammatory condition or prior allogeneic stem cell or solid organ transplant.
• Major surgical procedure.
• Known hypersensitivity to surovatamig or any of the excipients of the product.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

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Идентификаторы

NCT: NCT07509151 · D7409C00001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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