Venetoclax and Decitabine in R/R T-ALL

Официальное название

A Phase 2 Clinical Trial to Evaluate the Efficacy of VEnetoclax and DEciTabine in Relapsed/Refractory Adult T-acute Lymphoblastic lEukemia/Lymphoma

Обзор

The goal of this phase 2 clinical trial is to test the efficacy of decitabine and venetoclax combination chemotherapy in relapsed or refractory adult T-cell acute lymphoblastic leukemia/lymphoblastic lymphoma. This study use a modified regimen of decitabine and venetoclax.

Подробное описание

Our study is conducted in collaboration with Korean adult acute lymphoblastic leukemia working party (KALLWP) and consortium for improving survival of lymphoma (CISL). This study recruits adult patients with R/R T-ALL/LBL and treated with 7-day decitabine plus 3 weeks of venetoclax up to 12 cycles.

Вмешательства

• Препарат decitabine plus venetoclax
  decitabine 20mg/m2 for 7 days venetoclax 400mg daily for 21 days

Первичные конечные точки

• The rate of composite Complete remission [Срок оценки: 1 year]

Вторичные конечные точки (6)

• Composite overall response rate [Срок оценки: 1 year]
• Clinical benefit rate [Срок оценки: 1 year]
• Duration of response [Срок оценки: 1 year]
• Bridging to allogeneic hematopoietic stem cell transplantation (HSCT) [Срок оценки: 1 year]
• Progression-free survival (PFS) [Срок оценки: 1 year]
• Overall survival (OS) [Срок оценки: 1 year]

Критерии участия

Критерии включения

• Adults aged 19 years or older but less than 80 years
• Eastern Cooperative Oncology Group Performance Score (ECOG PS) ≤ 2
• Confirmed diagnosis of T-cell lymphoblastic leukemia/lymphoma according to the 2016 World Health Organization criteria, with relapse or failure to achieve complete remission despite induction chemotherapy
• Patients with peripheral blood leukocytes \<50,000/uL (reducing white blood cell count through hydroxyurea or leukapheresis prior to trial enrollment is allowed)
• At the time of screening, a calculated glomerular filtration rate (GFR) ≥ 30 mL/min according to the Cockcroft-Gault formulas, or creatinine ≤ 1.4, total bilirubin ≤ 3.0 mg/dL, and AST and ALT \< x5 upper limit of normal (ULN) (however, if bilirubin elevation is due to Gilbert\'s syndrome or liver enzyme elevation is due to infiltration of leukemia/lymphoma, enrollment may be allowed even if the above conditions are exceeded)
• Individuals who agree to the following contraceptive measures for a period of 3 months during treatment and for 3 months after completion:

Критерии исключения

• Individuals in complete remission with previous treatment, if relapse or resistance is not confirmed by bone marrow examination or imaging/tissue examination.
• Individuals who previously received venetoclax + decitabine treatment for T-lymphoblastic leukemia/lymphoma (participants who received venetoclax + decitabine treatment for a different type of cancer \[e.g., acute myeloid leukemia\] and have elapsed more than 1 year since the last treatment are allowed).
• Pregnant or breastfeeding individuals.
• Individuals who received systemic anticancer chemotherapy or participated in a clinical trial treatment within the past 2 weeks.
• Individuals with active leukemia involving the central nervous system.
• Individuals with a cancer type other than T-lymphoblastic leukemia/lymphoma that requires current active treatment (participants with a cancer type that has already been cured or is in a slow-progressing state without treatment, as determined by surgery/radiation/chemotherapy, may participate under the consultation of the clinical trial investigator).
• Individuals with active human immunodeficiency virus (HIV) infection, hepatitis B/hepatitis C infection (participants without evidence of viral particles through PCR testing may be enrolled with the consent of an infectious disease specialist or hepatologist).
• Uncontrolled bleeding.
• Uncontrolled infection (bacterial, fungal, viral).
• Uncontrolled mental illness.
• Individuals who do not understand the informed consent or have difficulty in adequate communication, making them inappropriate for participation in the clinical trial.
• Cases where the investigator judges that patient evaluation may be hindered or participation in the clinical trial is not appropriate.
• Individuals who have a negative attitude towards participating in the clinical trial or who are unwilling to comply with the treatment and specimen collection schedule specified in the study protocol.

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

South Korea · 3 центра

• Seoul National University Bundang Hospital — Seongnam-si
• Seoul National University Hospital — Seoul
• Seoul National University Hospital — Seoul

Идентификаторы

NCT: NCT06712121 · VEDETTE

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗