Chidamide in Combination With Azacitidine, Liposomal Mitoxantrone, and Prednisone (CAMP Regimen) for the Treatment of Previously Untreated Nodal TFH Cell Lymphoma

Официальное название

Evaluation of Chidamide in Combination With Azacitidine, Liposomal Mitoxantrone, and Prednisone (CAMP Regimen) for Reviously Untreated Nodal T-follicular Helper (TFH) Cell Lymphoma

Обзор

This study is investigating the effectiveness (specifically the objective response rate - ORR) of a new combination therapy called CAMP (chidamide, azacitidine, liposomal mitoxantrone, and prednisone) for previously untreated angioimmunoblastic T-cell lymphoma (AITL). It's a single-arm study comparing CAMP's safety and efficacy to standard treatments. Younger patients (≤70) receive the full CAMP regimen, while older patients receive a modified version (CAMP-light). Patients are assessed via PET-CT after 4 cycles. Responders (CR/PR) receive consolidation therapy and then maintenance chidamide for 2 years. Eligible patients achieving CR after 4 cycles can get a transplant, while those with PR need 2 more cycles first. Patients with stable or progressive disease after 4 cycles are withdrawn. Progression at any time leads to study discontinuation.

Подробное описание

Main Objective:

The primary objective of this study is to investigate the objective response rate (ORR) of chidamide in combination with azacitidine, liposomal mitoxantrone, and prednisone (CAMP regimen) for the treatment of treatment-naïve angioimmunoblastic T-cell lymphoma (AITL).

Study Design:

This study employs a single-arm design, based on the hypothesis that the safety profile of the chidamide, azacitidine, liposomal mitoxantrone, and prednisone (CAMP regimen) is superior to conventional treatment regimens, and that the efficacy, as measured by ORR, is non-inferior to conventional treatment regimens. Patients meeting the inclusion/exclusion criteria will be treated according to age: patients ≤70 years old will receive the CAMP regimen as first-line therapy, while patients \>70 years old will receive a modified CAMP regimen (CAMP-light) as first-line therapy. Interim efficacy will be assessed via PET-CT scan after the 4th cycle of chemotherapy, with PET-CT results interpreted using the Deauville 5-point scale.

Treatment and Follow-up:

Patients achieving a complete response (CR) or partial response (PR) at the interim assessment will continue with 2 cycles of consolidation therapy using the CAMP regimen or CAMP-light regimen. Subsequently, they will enter single-agent chidamide maintenance therapy (≤70 years old: chidamide 30mg orally, twice weekly; \>70 years old: chidamide 20mg orally, twice weekly), which will continue for 24 months.

Patients eligible for transplantation who achieve a CR after 4 cycles of induction therapy may proceed to autologous stem cell transplantation (ASCT). Patients achieving a PR will receive 2 additional cycles of consolidation therapy before undergoing ASCT. Patients with a PR at the interim assessment will undergo a repeat PET-CT scan before transplantation to reassess efficacy. Stem cell mobilization for transplant-eligible patients will utilize steady-state mobilization with or without plerixafor.

Patients exhibiting stable disease (SD) or progressive disease (PD) at the interim assessment after 4 cycles will be withdrawn from the study.

Patients experiencing PD at any time during the treatment course will be discontinued from the study upon confirmation of progression.

Вмешательства

• Препарат Chidamide
  chidamide 30mg biw, p.o, 21 days for a cycle.
• Препарат Azacitidine
  75mg/m2, continuous i.h. on day 1-7，21 days for a cycle.
• Препарат liposomal mitoxantrone
  12mg/m2， d1,21 days for a cycle.
• Препарат prednisone
  60mg/m2，d1-5,21 days for a cycle.

Первичные конечные точки

• Objective Response Rate (ORR) [Срок оценки: 2 years post initiation of treatment]
• Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [Срок оценки: 2 years post initiation of treatment]

Вторичные конечные точки (3)

• Progression-Free Survival (PFS) [Срок оценки: 2 years post initiation of treatment]
• Duration of Response (DOR) [Срок оценки: 2 years post initiation of treatment]
• Overall Survival (OS) [Срок оценки: 2 years post initiation of treatment]

Критерии участия

Критерии включения

• Subjects must have histological confirmation of nodal T-follicular helper (TFH) cell lymphoma.
• More than 18 years of age.
• Proper functioning of the major organs: 1) The absolute value of neutrophils (≥1×10\^9/L); 2) platelet count (≥75×10\^9/L); 3) Serum total bilirubin ≤ 1.5 times ULN; 4) Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) ≤3 times ULN; 5) Serum creatinine (Cr) ≤2 ULN, or glomerular filtration rate ≥40ml/min;
• Eastern Cooperative Oncology Group (ECOG) Performance status 0-2.
• LVEF value measured by echocardiography ≥50%.
• Life expectancy > 3 months.

Критерии исключения

• Patients who have previously received chemotherapy, radiotherapy or other antitumor therapy.
• Patients with central nervous system involvement by lymphoma.
• Patients with uncontrolled cardiovascular and cerebrovascular diseases, coagulation disorders, connective tissue diseases, serious infectious diseases and other diseases.
• Pregnant or breastfeeding women.
• Presence of human immunodeficiency virus (HIV) virus infection.
• Previous history of other malignant tumors, unless the disease has been cured for 5 years or more. The following cured tumors are excluded:

• Basal cell carcinoma of the skin, squamous cell carcinoma of the skin and related localized non-melanoma skin cancers;
• Carcinoma in situ of the cervix

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Institute of Hematology & Blood Diseases Hospital — Тяньцзинь

Идентификаторы

NCT: NCT05958719 · IIT2023003

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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